US Market News
1週前
Personalis Highlights Early Colorectal Cancer Recurrence Detection and Ultrasensitive MRD Performance Across a Broad Set of Tumor Types at ASCO 2026June 2, 2026 6:00 AM
Business Wire NeXT Personal® MRD test showed 100% sensitivity for CRC recurrence during surveillance and 82% landmark sensitivity 4 weeks post-surgery Ultrasensitive NeXT Personal performance was demonstrated across 6 different solid tumor types Personalis, Inc. (Nasdaq: PSNL) today announced clinical data from the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting establishing the clinical importance of ultrasensitive MRD detection across six solid tumor types, led by the VICTORI colorectal cancer and TRACERx lung cancer studies. “Our ASCO data continues to build on a compelling body of evidence, including recent landmark publications, that show ultrasensitive MRD detection with NeXT Personal enables early detection of patients at risk for relapse, across a broad set of solid tumor types,” said Richard Chen, MD, MS, President and Chief Medical Officer of Personalis. “These data, along with our recent Medicare approvals, further our mission to provide cancer patients with the precision MRD testing they need to help guide clinical management.” Key clinical themes and data presented at the meeting included: Exceptional Performance in Colorectal Cancer The prospective VICTORI study (Abstract #396), led by the University of British Columbia, monitored over 100 Stage I-IV resectable CRC patients with NeXT Personal. Highlights from the interim analysis include: 100% sensitivity for cancer relapse during surveillance, ahead of imaging: NeXT Personal successfully detected 100% of all patient relapses in the cohort ahead of clinical imaging, including all distant metastases in historically difficult-to-detect regions like the lung. 82% landmark sensitivity at 4 weeks after surgery: Just four weeks after surgery, the test detected 82% of patients who later relapsed, providing clinicians with a highly reliable early signal of cancer to inform treatment pathways. Importance of Sub-10 ppm Sensitivity in Lung Cancer In an oral podium presentation (Abstract #8017), investigators from University College London utilized the landmark TRACERx cohort to analyze 431 Stage IA-IIIB non-small cell lung cancer (NSCLC) patients using NeXT Personal. The study demonstrated the clinical utility of detecting ctDNA at ultra-low thresholds: Consistent Ultra-Low Limits of Detection: NeXT Personal demonstrated consistent detection of ctDNA at ultra-low levels in this study, achieving a median limit of detection (LOD) of 1.66 ppm. Prevalence of Sub-10 ppm Detections: Building on prior NeXT Personal publications showing approximately 40% of TRACERx detections were in the ultrasensitive range (80% landmark sensitivity as early as four weeks post-surgery, serve as a non-invasive alternative to other diagnostic procedures (such as SLL), inform treatment pathways, evaluate treatment response, or predict patient outcomes; future clinical data differing from the clinical data previously presented or expected results; the rate of adoption and use of the NeXT Personal test; changes in health care policy, which could increase Personalis’ costs, decrease Personalis’ revenue, and impact sales of and reimbursement for Personalis’ tests; Personalis’ ability to obtain Medicare coverage and reimbursement and the timing thereof; the impact of competition and macroeconomic factors on Personalis’ business; the partnering and/or collaboration arrangements that Personalis has entered into or may enter into in the future may not be successful, or may terminate, which could adversely impact Personalis’ business or affect its ability to develop and commercialize its services and products; having a limited number of suppliers; and customer concentration. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (SEC) on February 26, 2026, and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 7, 2026. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260602445979/en/ Investor Relations:
Caroline Corner
US Market News
2週前
Personalis to Highlight Breadth of NeXT Personal® Ultra-Sensitive ctDNA Data at ASCO 2026 Annual Meeting, Including Podium Presentation from TRACERx ConsortiumMay 26, 2026 6:00 AM
Business Wire Abstracts span six cancer types, including new data on single-digit parts-per-million ctDNA detection Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced that six clinical abstracts demonstrating the broad use of its NeXT Personal® test will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 to June 2 in Chicago. Highlights include an oral podium presentation from the landmark TRACERx study, which demonstrates the clinical impact of NeXT Personal’s single-digit parts-per-million (ppm) sensitivity in early-stage non-small cell lung cancer (NSCLC). By detecting circulating tumor DNA (ctDNA) at these ultra-low thresholds, NeXT Personal continues to set new benchmarks for MRD test performance. “At ASCO, our collaborators will present data that underscores the critical importance of ultrasensitive MRD testing across six distinct solid tumor types, including exceptional new data in colorectal and lung cancer,” said Richard Chen, MD, President and Chief Medical Officer of Personalis. “This data builds upon foundational evidence from our landmark publications in breast cancer, lung cancer, and immunotherapy monitoring, confirming that the ultrasensitive detection provided by NeXT Personal enables early identification of recurrence and precise assessments of therapy response.” Key clinical highlights at ASCO include: Ultrasensitive Colorectal Cancer Data (VICTORI Study): Updated results from the prospective VICTORI surveillance cohort, led by the University of British Columbia, highlight NeXT Personal’s strong performance in detecting ctDNA among Stage I-III colorectal cancer patients. The test achieved 100% longitudinal sensitivity for recurrence—including difficult-to-detect metastatic sites—and >80% landmark sensitivity as early as four weeks post-surgery. Clinical Importance of Ultrasensitive ctDNA Detection at Single-Digit Levels (TRACERx Podium Presentation): Utilizing samples from the TRACERx lung cancer cohort, investigators demonstrate that NeXT Personal ctDNA detections at the very lowest levels 80% landmark sensitivity as early as four weeks post-surgery. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to Personalis’ ability to demonstrate attributes, advantages or clinical validity or utility of the NeXT Personal test, including the NeXT Personal MRD assay remaining unique in its ability to detect traces of cancer in the ultrasensitive range; future clinical data differing from the clinical data previously presented or expected results; the rate of adoption and use of the NeXT Personal test; changes in health care policy, which could increase Personalis’ costs, decrease Personalis’ revenue, and impact sales of and reimbursement for Personalis’ tests; Personalis’ ability to obtain Medicare coverage and reimbursement in additional indications and the timing thereof; the impact of competition and macroeconomic factors on Personalis’ business; the partnering and/or collaboration arrangements that Personalis has entered into or may enter into in the future may not be successful, or may terminate, which could adversely impact Personalis’ business or affect its ability to develop and commercialize its services and products; having a limited number of suppliers; and customer concentration. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on February 26, 2026, and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 7, 2026. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law. Not affiliated with or endorsed by ASCO. View source version on businesswire.com: https://www.businesswire.com/news/home/20260526794601/en/ Investors:
Caroline Corner
US Market News
3週前
Personalis Secures Fourth Medicare Coverage Decision for NeXT Personal®, Expanding Breast Cancer Coverage to Pre-Surgical Treatment MonitoringMay 20, 2026 6:00 AM
Business Wire Expanded coverage enables Medicare beneficiaries with Stage II-III TNBC or HER2+ breast cancer to access ultrasensitive MRD testing to monitor response to neoadjuvant therapy Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced that the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostic Services Program (MolDX) has expanded coverage for the company’s NeXT Personal minimal residual disease (MRD) test. The new coverage determination is for monitoring treatment response to neoadjuvant therapy (NAT) in patients diagnosed with Stage II-III Triple-Negative Breast Cancer (TNBC) or HER2-positive (HER2+) breast cancer. This decision marks Personalis’ fourth Medicare coverage milestone for NeXT Personal, expanding the test's clinical use in breast cancer. While previous coverage enabled post-surgical recurrence surveillance, this new milestone extends Medicare coverage into the neoadjuvant setting, allowing clinicians to utilize NeXT Personal's ultrasensitive technology to actively monitor therapy effectiveness before a patient undergoes surgery. The coverage determination is underpinned by clinical evidence from the prospective PREDICT-DNA study, recently published in the Journal of Clinical Oncology (JCO). The study followed 227 patients with TNBC and HER2+ breast cancer across more than 24 leading US cancer centers. Data from that study demonstrated that ultrasensitive ctDNA monitoring with NeXT Personal allows accurate tracking of neoadjuvant therapy response and outperforms traditional clinical metrics in predicting long-term patient outcomes. "Securing our fourth Medicare coverage decision for NeXT Personal is another milestone that moves our technology into active treatment management," said Chris Hall, Chief Executive Officer of Personalis. "We are focused on enabling a better outcome for patients by using our ultrasensitive MRD technology to help guide decisions throughout their clinical journey." A key finding of the PREDICT-DNA study was the clinical necessity of the ultrasensitive range for accurately tracking patient response to neoadjuvant therapy. Nearly half of all ctDNA detections following NAT occurred at levels below 100 parts per million (PPM)—low-level traces of cancer that less sensitive MRD assays can miss. "The clinical data published in JCO clearly show that neoadjuvant monitoring benefits from a highly quantitative, ultrasensitive test to capture treatment response dynamics. NeXT Personal’s unique ability to track up to ~1,800 patient-specific variants provides the resolution physicians need to confidently track treatment response," said Richard Chen, MD, President and Chief Medical Officer at Personalis. "With neoadjuvant therapy as the standard of care in a number of breast cancer settings, we are thrilled to expand access to NeXT Personal for those patients and take another step forward in our mission to transform cancer care through personalized testing.” About Personalis, Inc. At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts, including statements relating to: the attributes, advantages, sensitivity, and clinical relevance of the NeXT Personal test, the duration of Medicare coverage in the neoadjuvant therapy monitoring setting, our ability to drive a new paradigm for cancer management and the design of Personalis’ products. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to Personalis’ ability to demonstrate attributes, advantages or clinical validity of the NeXT Personal test, including the NeXT Personal MRD assay remaining unique in its ability to detect traces of cancer in the ultrasensitive range, and the ability of the NeXT Personal test to evaluate treatment response and predict outcomes in patients undergoing neoadjuvant therapy; future clinical data differing from the clinical data previously presented or expected results; the rate of adoption and use of the NeXT Personal test; changes in health care policy, which could increase Personalis’ costs, decrease Personalis’ revenue, and impact sales of and reimbursement for Personalis’ tests; Personalis’ ability to obtain Medicare coverage and reimbursement in additional indications and the timing thereof; the impact of competition and macroeconomic factors on Personalis’ business; the partnering and/or collaboration arrangements that Personalis has entered into or may enter into in the future may not be successful, or may terminate, which could adversely impact Personalis’ business or affect its ability to develop and commercialize its services and products; having a limited number of suppliers; and customer concentration. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (SEC) on February 26, 2026, and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 7, 2026. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260520448802/en/ Investor Relations:
Caroline Corner
US Market News
2月前
Personalis Highlights Clinical Impact of Ultrasensitive ctDNA Monitoring and New Therapy Resistance Tracking at AACR 2026April 21, 2026 6:00 AM
Business Wire
Podium presentation on NeXT Personal® monitoring neoadjuvant therapy in colorectal cancer;
Real-world data from 10,000 patients reinforce industry-leading sensitivity;
Data presented for a new NeXT Personal feature for monitoring resistance mutations
Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced the successful presentation of clinical data at the American Association for Cancer Research (AACR) Annual Meeting. The data, spanning one oral podium presentation and three posters, underscore the use of the NeXT Personal ultrasensitive ctDNA assay in monitoring treatment response, identifying early recurrence, and tracking the emergence of therapy resistance.
Neoadjuvant Monitoring in Colorectal Cancer. A highlight was the oral podium presentation of the NEOPRISM-CRC trial, delivered by Dr. Jiang from the University College London, which utilized NeXT Personal to monitor patients with high-risk stage II-III dMMR/MSI-H colorectal cancer (CRC) receiving neoadjuvant pembrolizumab. In addition to 100% sensitivity for disease at baseline, the study identified three distinct groups of patient response to neoadjuvant treatment: super molecular responders, dynamic molecular responders, and poor molecular responders. Notably, 100% of "super molecular responders"—those who cleared ctDNA by the second cycle of treatment—also achieved pathological complete response (pCR). Conversely, of “poor molecular responders”—patients with relatively stable ctDNA levels during neoadjuvant treatment—100% did not achieve pCR. These findings could provide clinicians with a critical window to adjust treatment strategies prior to surgery. Post-surgery, the test achieved a 100% negative predictive value (NPV) and 100% specificity for disease relapse.
"The data presented at AACR confirm ultrasensitive ctDNA detection with NeXT Personal as a promising therapy monitoring tool in neoadjuvant colorectal cancer treatment,” said Dr. Richard Chen, President and Chief Medical Officer at Personalis. "By measuring molecular response with high resolution, we are providing the tools needed to explore ctDNA-guided management of colorectal cancer patients receiving neoadjuvant therapy."
Ultrasensitivity in Real-World Data. In a large-scale analysis of nearly 25,000 plasma samples from 10,000 real-world patients, NeXT Personal demonstrated consistent ultrasensitive performance with a median limit of detection of 1.92 PPM. The study also revealed that 39% of all positive MRD detections occurred in the ultrasensitive range below 100 PPM, with 14.6% below 10 PPM—detections that could be missed with less sensitive assays. This study also highlights the robust ultrasensitive performance of the NeXT Personal assay in real-world testing conditions across more than 14 cancer types, stage I-IV disease, and a variety of challenging sample types.
Innovation in Therapy Resistance Tracking. Personalis also debuted analytical validation and real-world data for a new opt-in feature of its NeXT Personal MRD test: Real-Time Variant Tracker™. This feature allows for the simultaneous monitoring of MRD and the longitudinal tracking of specific resistance-associated mutations, such as ESR1. With a specificity of >99.9%, resistance and other clinical mutations were identified in 38% of MRD-positive patients across the real-world cohort, offering a new tool for tracking treatment resistance as it emerges.
Monitoring Immunotherapy Response in NSCLC. The DARWIN 2 study results in metastatic non-small cell lung cancer (NSCLC) demonstrated NeXT Personal’s ability to stratify risk in patients receiving immunotherapy. Patients who achieved a durable molecular complete response (dmCR) remained 100% progression-free at three years, whereas patients who failed to achieve molecular clearance were five times more likely to experience disease progression.
Together, these studies illustrate Personalis’ commitment to improving cancer management through ultrasensitive MRD testing throughout the patient journey.
About Personalis, Inc.
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and can generally be identified by terms such as “believe,” “expect,” “if,” “may,” “will” or similar expressions. These statements include those relating to: the use, clinical impact or real-world clinical performance of NeXT Personal, the ability of NeXT Personal or the Real-Time Variant Tracker feature to inform cancer monitoring or patient management, predict or track therapy response, detect resistance or other clinical mutations, predict relapse, or predict or impact patient outcomes. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to Personalis’ ability to demonstrate attributes, advantages or clinical validity or utility of the NeXT Personal test and the Real-Time Variant Tracker option, including the NeXT Personal MRD assay remaining unique in its ability to detect traces of cancer in the ultrasensitive range and its ability to monitor mutations; future clinical data differing from the clinical data previously presented or expected results; the rate of adoption and use of the NeXT Personal test; changes in health care policy, which could increase Personalis’ costs, decrease Personalis’ revenue, and impact sales of and reimbursement for Personalis’ tests; the impact of competition and macroeconomic factors on Personalis’ business; the partnering and/or collaboration arrangements that Personalis has entered into or may enter into in the future may not be successful, or may terminate, which could adversely impact Personalis’ business or affect its ability to develop and commercialize its services and products; having a limited number of suppliers; and customer concentration. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on February 26, 2026. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.
Not affiliated with or endorsed by AACR.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260421790003/en/
Investors:
Caroline Corner
investors@personalis.com
415-202-5678
Media Contact:
pr@personalis.com
Original: Personalis Highlights Clinical Impact of Ultrasensitive ctDNA Monitoring and New Therapy Resistance Tracking at AACR 2026
US Market News
2月前
Personalis and Collaborators to Highlight Ultrasensitive ctDNA Data and New Therapy Resistance Tracking Capabilities at AACR 2026April 13, 2026 6:00 AM
Business Wire
Oral podium presentation to highlight NeXT Personal® in colorectal cancer; Personalis to debut first data for Real-Time Variant Tracker™ to monitor therapy resistance during NeXT Personal MRD testing
Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced today that an oral podium presentation featuring colorectal cancer data for the company’s NeXT Personal ultrasensitive ctDNA assay and three posters will be presented at the American Association for Cancer Research (AACR) Annual Meeting April 17-22, 2026, in San Diego, California.
A focus of this year’s data is the introduction of a new NeXT Personal MRD test option, Real-Time Variant Tracker, a first-of-its-kind feature in tumor-informed clinical MRD testing, designed to longitudinally track therapy resistance mutations.
"We are thrilled to present the first NeXT Personal data on the Real-Time Variant Tracker. The AACR data highlights how tracking therapy resistance mutations like ESR1 during MRD testing has the potential to inform patient management once cancer recurrence is detected," said Dr. Richard Chen, President and Chief Medical Officer at Personalis. “In addition, the data presented at AACR further reinforces that ultrasensitive ctDNA detection with NeXT Personal can impact how colorectal cancer is monitored and managed. Both of these studies are examples of our unwavering commitment to innovation to drive better outcomes for patients."
Presentations at AACR highlighting the use and clinical impact of the ultrasensitive NeXT Personal MRD test include:
Oral Podium Presentation: Neoadjuvant pembrolizumab stratified by tumor mutation burden in high-risk stage II-III dMMR/MSI colorectal cancer (NEOPRISM-CRC): Perioperative ultrasensitive ctDNA monitoring and tumor-infiltrating TCR repertoire for treatment response prediction.
Focus: Highlights the ultrasensitive ctDNA detection of NeXT Personal for predicting and tracking response to neoadjuvant immunotherapy in CRC patients.
Time: April 20, 2026, 2:35 PM–2:45 PM
Location: Room Hall H - Ground Level
Poster Presentation: Monitoring ESR1 and other mutations linked to resistance with a tumor-informed MRD test: Analytical validation and real world data.
Focus: Presents the analytical validation and real-world case studies of the new Real-Time Variant Tracker feature of NeXT Personal enabling detection of resistance and other clinical mutations during MRD testing.
Time: April 20, 2026, 9:00 AM–12:00 PM
Location: Section 46, Poster #2588
Poster Presentation: Enhancing MRD detection through an ultrasensitive ctDNA test: Insights from real-world clinical data.
Focus: A deep analysis of the real-world clinical performance of NeXT Personal across a large patient cohort. The data highlights the ability for NeXT Personal to consistently achieve ultrasensitive ctDNA detection levels below 100 parts per million (ppm) and 10 ppm, across a diverse set of solid tumor types, stages, and challenging real-world testing conditions.
Time: April 20, 2026, 2:00 PM–5:00 PM
Location: Section 45, Poster #8225
Poster Presentation: Ultrasensitive ctDNA monitoring predicts early response of immunotherapy in recurrent metastatic non-small cell lung cancer.
Focus: Demonstrates the performance of NeXT Personal for predicting relapse and outcomes in advanced NSCLC patients receiving immunotherapy.
Time: April 20, 2026, 2:00 PM–5:00 PM
Location: Section 45, Poster #3851
About Personalis, Inc.
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and can generally be identified by terms such as “believe,” “expect,” “if,” “may,” “will” or similar expressions. These statements include those relating to: the use, clinical impact or real-world clinical performance of NeXT Personal, the ability of NeXT Personal or the Real-Time Variant Tracker feature to inform cancer monitoring or patient management, predict or track therapy response, detect resistance or other clinical mutations, predict relapse, or predict or impact patient outcomes. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to Personalis’ ability to demonstrate attributes, advantages or clinical validity or utility of the NeXT Personal test and the Real-Time Variant Tracker option, including the NeXT Personal MRD assay remaining unique in its ability to detect traces of cancer in the ultrasensitive range and its ability to monitor mutations; future clinical data differing from the clinical data previously presented or expected results; the rate of adoption and use of the NeXT Personal test; changes in health care policy, which could increase Personalis’ costs, decrease Personalis’ revenue, and impact sales of and reimbursement for Personalis’ tests; the impact of competition and macroeconomic factors on Personalis’ business; the partnering and/or collaboration arrangements that Personalis has entered into or may enter into in the future may not be successful, or may terminate, which could adversely impact Personalis’ business or affect its ability to develop and commercialize its services and products; having a limited number of suppliers; and customer concentration. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on February 26, 2026. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.
Not affiliated with or endorsed by AACR.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260413770148/en/
Investors:
Caroline Corner
investors@personalis.com
415-202-5678
Media Contact
pr@personalis.com
Original: Personalis and Collaborators to Highlight Ultrasensitive ctDNA Data and New Therapy Resistance Tracking Capabilities at AACR 2026
US Market News
2月前
Personalis to Participate in the 25th Annual Needham Virtual ConferenceApril 1, 2026 4:01 PM
Business Wire
Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced today that its management team will be participating in the 25th Annual Needham Virtual Conference on Wednesday, April 15, 2026.
About Personalis, Inc.
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).
View source version on businesswire.com: https://www.businesswire.com/news/home/20260401441917/en/
Investor Relations:
Caroline Corner
investors@personalis.com
415-202-5678
Media:
pr@personalis.com
Original: Personalis to Participate in the 25th Annual Needham Virtual Conference
US Market News
3月前
Personalis Appoints Dr. Richard Chen as President to Further Accelerate MRD AdoptionMarch 17, 2026 4:00 PM
Business Wire
Dr. Chen expands his leadership role to serve as President while continuing to serve as Chief Medical Officer (CMO), unifying R&D innovation with operational execution as Personalis defines the next era of ultrasensitive MRD testing
Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced the promotion of Richard Chen, M.D., M.S., to the position of President. Dr. Chen will continue to serve as CMO of Personalis in addition to his new role.
The appointment comes at a critical inflection point as Personalis transitions from a pioneering R&D powerhouse into a market leader in Minimal Residual Disease (MRD) testing. Under Dr. Chen’s scientific leadership, Personalis developed and accelerated adoption of the NeXT Personal® platform, which set a new industry benchmark for ultrasensitive MRD testing, detecting cancer at levels far below those previously achievable.
"Personalis is no longer just participating in the MRD market; we are defining its future," said Chris Hall, Chief Executive Officer of Personalis. "Rich has been the principal architect of our most significant product and technology leaps, including NeXT Personal, and designed the clinical evidence strategy that has accelerated adoption of our ultrasensitive MRD tests. By elevating him to President, we are aligning our visionary R&D with the need to integrate the technology into pharmaceutical drug trials and physician workflows to help patients fight cancer."
As President, Dr. Chen will oversee the integration of the company’s R&D capabilities, biopharma services, reimbursement, quality systems and medical affairs to capitalize on the technical excellence of the Personalis platform and accelerate revenue growth.
"The work we have done with NeXT Personal has proven that ultra sensitivity is central to enabling earlier detection and intervention for cancer patients, and, just as important, more peace of mind for patients with a negative test result," said Dr. Chen. "We have pioneered a new path in the market and I am excited to step into this expanded role to help lead the scaling of the company. Our goal is clear: to make ultrasensitive MRD testing the standard of care for every cancer patient, ensuring earlier detection and better outcomes."
Dr. Chen’s promotion reinforces the company’s commitment to scientific rigor as it scales its commercial footprint. His deep expertise in genomic medicine and machine learning, and his track record of moving innovative R&D projects into high-growth clinical products, make him the ideal leader to help drive this next phase of the company's evolution.
About Personalis, Inc.
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and can generally be identified by terms such as “believe,” “expect,” “if,” “may,” “will” or similar expressions. These statements include those relating to: Personalis’ role in defining the future of the MRD market; the expected benefits of aligning research and development capabilities with integration of Personalis’ technology into pharmaceutical drug trials and physician workflows, including ultrasensitive MRD testing becoming the standard of care, earlier detection, better outcomes and future revenue growth; and Personalis’ market leadership, performance, plans and expectations. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to Personalis’ ability to demonstrate attributes, advantages or clinical validity or utility of the NeXT Personal test, including the NeXT Personal MRD assay remaining unique in its ability to detect traces of cancer in the ultrasensitive range; the integration of R&D capabilities, biopharma services, reimbursement, quality systems and medical affairs under Dr. Chen's leadership translating into accelerated revenue growth; the rate of adoption and use of the NeXT Personal test; changes in health care policy, which could increase Personalis’ costs, decrease Personalis’ revenue, and impact sales of and reimbursement for Personalis’ tests; the impact of competition and macroeconomic factors on Personalis’ business; having a limited number of suppliers; and customer concentration. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on February 26, 2026. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260317575420/en/
Investor Relations:
Caroline Corner
investors@personalis.com
415-202-5678
Media Contact:
Patrick Schmidt
pr@personalis.com
630-290-2787
Original: Personalis Appoints Dr. Richard Chen as President to Further Accelerate MRD Adoption
US Market News
3月前
Personalis Announces New Publication Advancing Neoadjuvant Treatment Monitoring in Breast Cancer with NeXT Personal®March 12, 2026 6:00 AM
Business Wire
Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced the publication of the PREDICT-DNA study in the Journal of Clinical Oncology. The article, "The Pathologic Response Evaluation and Detection In Circulating Tumor-DNA (PREDICT-DNA) study: Ultrasensitive ctDNA Assessment of Breast Cancer Minimal Residual Disease," showed that ultrasensitive molecular residual disease (MRD) testing with NeXT Personal can perform better than current standard approaches in predicting patient outcomes following neoadjuvant therapy (NAT).
The prospective study followed 227 patients with Triple-Negative (TNBC) and HER2+ breast cancer across more than 24 leading US cancer centers. The results demonstrate the ability of NeXT Personal to provide a more precise risk-stratification for patients who have received NAT.
A key finding of the study was the necessity of the ultrasensitive range for accurately tracking patient response to neoadjuvant therapy. Of note, 55% of all ctDNA detections following NAT occurred at levels below 100 parts per million, detections that could be missed with less sensitive tests.
“Many breast cancer patients receive neoadjuvant therapy as standard of care, prior to surgery. The results of this study suggest that an ultrasensitive ctDNA assay like NeXT Personal could help patients better understand their response to neoadjuvant therapy, with the potential to help inform the need for additional therapy,” said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. “The publication of this data is important as we look to expand reimbursement and improve the tools used in neoadjuvant monitoring.”
Key study highlights include:
High Prognostic Power: Detectable ctDNA post-NAT was associated with a 4 to 9 times higher likelihood of relapse.
Superior to Traditional Metrics: In multivariate analyses, ctDNA status was the most significant independent prognostic signal, performing better than nodal status, tumor grade, and pathologic complete response (pCR) status. In addition, ctDNA detection post-NAT was a stronger predictor of recurrence than pCR status.
Identification of Low Risk: Patients who were ctDNA-negative post-NAT showed excellent outcomes, regardless of pCR status.
Post-Surgical Relapse Prediction: Patients with detectable ctDNA up to 12 months post-surgery were more than 100 times more likely to experience disease recurrence.
“We partnered with Personalis because their technology offers a level of sensitivity down to 1 to 3 parts per million that allows for a higher cancer detection rate," said Dr. Ben Park, MD, PhD, Director of the Vanderbilt-Ingram Cancer Center. "The PREDICT-DNA results show that if a patient clears their ctDNA, their outcomes are excellent even if residual disease is found at surgery. Conversely, detectable ctDNA signals a very high risk. These insights allow us to more precisely risk-stratify breast cancer patients in future trials and clinical practice.”
The findings reinforce the NeXT Personal test’s ability to detect ctDNA at ultrasensitive levels, providing a window for earlier clinical intervention that other approaches may miss. The NeXT Personal test achieves ultrasensitive detection of small traces of ctDNA from a patient’s blood sample using a personalized approach that tracks up to ~1,800 tumor-specific variants unique to each patient’s tumor.
About Personalis, Inc.
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts, including statements relating to the attributes, advantages, sensitivity, and clinical relevance (including prognostic power, risk-stratification capabilities and superiority to traditional metrics) of the NeXT Personal test and the potential impact or expected benefits of the PREDICT-DNA study. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to Personalis’ ability to demonstrate attributes, advantages or clinical validity or utility of the NeXT Personal test, including the NeXT Personal MRD assay remaining unique in its ability to detect traces of cancer in the ultrasensitive range; future clinical data differing from the clinical data previously presented or expected results; the ability of Personalis to expand reimbursement for, or the rate of adoption and use of, the NeXT Personal test; changes in health care policy, which could increase Personalis’ costs, decrease Personalis’ revenue, and impact sales of and reimbursement for Personalis’ tests; the impact of competition and macroeconomic factors on Personalis’ business; the partnering and/or collaboration arrangements that Personalis has entered into or may enter into in the future, which may not be successful, or may terminate, which could adversely impact Personalis’ business or affect its ability to develop and commercialize its services and products; having a limited number of suppliers; and customer concentration. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (SEC) on February 26, 2026. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260312182084/en/
Investor Relations:
Caroline Corner
investors@personalis.com
415-202-5678
Media Contact:
Patrick Schmidt
pr@personalis.com
630-290-2787
Original: Personalis Announces New Publication Advancing Neoadjuvant Treatment Monitoring in Breast Cancer with NeXT Personal®
US Market News
4月前
Personalis to Participate in the TD Cowen 46th Annual Healthcare ConferenceFebruary 17, 2026 4:01 PM
Business Wire
Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced today that its management team will be attending the TD Cowen 46th Annual Healthcare Conference on Tuesday, March 3, 2026 at the Boston Marriott Copley Place in Boston, MA.
About Personalis, Inc.
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).
View source version on businesswire.com: https://www.businesswire.com/news/home/20260217655785/en/
Investor Relations:
Caroline Corner
investors@personalis.com
415-202-5678
Media:
pr@personalis.com
Original: Personalis to Participate in the TD Cowen 46th Annual Healthcare Conference
US Market News
4月前
Personalis Announces New Publication Expanding Evidence for Ultrasensitive ctDNA Monitoring of Cancer Immunotherapy Response Across Solid TumorsFebruary 2, 2026 6:00 AM
Business Wire
Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced the publication of a new study in npj Precision Oncology highlighting the power of its ultrasensitive molecular residual disease (MRD) assay, NeXT Personal®, in monitoring immunotherapy response across a broad range of advanced cancers.
The study, titled "Ultrasensitive ctDNA monitoring reveals early predictors of immunotherapy response in advanced cancer," was led by oncology researchers at UC San Diego Moores Cancer Center.
The findings reinforce the NeXT Personal test’s ability to detect circulating tumor DNA (ctDNA) at ultrasensitive levels, providing a window for earlier clinical intervention that other approaches may miss. The NeXT Personal test achieves ultrasensitive detection of small traces of ctDNA from a patient’s blood sample using a personalized approach that tracks up to ~1,800 tumor-specific variants unique to each patient’s tumor.
While immunotherapy has transformed cancer care, only ~10-40% of patients achieve durable benefit, making it critical to monitor how patients are responding to therapy. This interim analysis of the ongoing study includes 39 patients with advanced solid tumors—across nine different cancer types—treated with immune checkpoint inhibitors alone or in combination with other therapies. Key findings include:
Early identification of therapy response: Molecular response—defined by ctDNA dynamics—was detectable early, a median of 23 days after starting immunotherapy. Patients achieving an early molecular response had significantly longer progression-free survival.
Lead time over imaging: For patients whose disease progressed, NeXT Personal identified molecular progression a median of 161 days (over five months) before imaging.
Criticality of the ultrasensitive range in advanced tumors: The study found that even in advanced tumors where ctDNA shedding can be higher, 33% of positive ctDNA detections occurred in the ultrasensitive range (below 100 PPM). These are detections that could be missed with a less sensitive test.
Strong correlation with outcomes: Patients who achieved molecular complete response (ctDNA clearance) had seven times higher overall survival than patients who did not achieve ctDNA clearance.
"We continue to expand the clinical evidence that NeXT Personal can be used to monitor therapy response in advanced cancer patients on immunotherapy," said Richard Chen, M.D., M.S., Chief Medical Officer and Executive Vice President of R&D at Personalis. “This pan-cancer study builds on our recent publication in Clinical Cancer Research, similarly showing the impact of ultrasensitive ctDNA testing in late-stage cancers. With immunotherapy, an important pillar of cancer treatment in advanced cancer patients, the need for better tools to evaluate patient response is increasingly important. These findings show how NeXT Personal and ultrasensitive ctDNA testing can potentially play an important role in impacting care across a broad spectrum of solid tumors."
About Personalis, Inc.
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts, including statements relating to: the attributes, advantages, sensitivity, and clinical relevance of the NeXT Personal test and the potential impact or expected benefits of the UCSD study. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to Personalis’ ability to demonstrate attributes, advantages or clinical validity of the NeXT Personal test, including the NeXT Personal MRD assay remaining unique in its ability to detect traces of cancer in the ultrasensitive range; future clinical data differing from the clinical data previously presented or expected results; the rate of adoption and use of the NeXT Personal test; changes in health care policy, which could increase Personalis’ costs, decrease Personalis’ revenue, and impact sales of and reimbursement for Personalis’ tests; the impact of competition and macroeconomic factors on Personalis’ business; the partnering and/or collaboration arrangements that Personalis has entered into or may enter into in the future, which may not be successful, or may terminate, which could adversely impact Personalis’ business or affect its ability to develop and commercialize its services and products; having a limited number of suppliers; and customer concentration. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on February 27, 2025 as updated by Personalis’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 4, 2025. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260202837412/en/
Investor Relations:
Caroline Corner
investors@personalis.com
415-202-5678
Media Contact
Patrick Schmidt
pr@personalis.com
630-290-2787
Original: Personalis Announces New Publication Expanding Evidence for Ultrasensitive ctDNA Monitoring of Cancer Immunotherapy Response Across Solid Tumors
MiamiGent
2年前
LOL, folks, putzkpz is here! He's the Jim Cramer of ihub. EVERY call (and there have been so many) he makes against my plays, loses.
Then he goes away to save up money, comes back to bet it against my play, loses, and then ..... I don't where he goes to get fresh money, maybe picks up work at McDonalds. I know he spends a lot of time in ihub jail.
putzkpz, I'm too old and busy for your chronic nonsense. I'm going to have to put you in the Ignore Stable with that pompous burro here from yesterday, "tt". I hope you two can get along. He's delusional, thinks he's a "master chartist" (his words) but can't see on the chart a stock coming out of consolidation, and you're just bat-chit crazy.
Play nice together. I don't provide adult supervision of the donkeys in my Ignore Stable.