Guardant Health Receives EU IVDR Certification for Guardant360® CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications
2024年5月21日 - 9:05PM
ビジネスワイヤ(英語)
- Blood-based test for comprehensive genomic profiling of solid
cancers meets requirements under stricter EU In Vitro Diagnostic
Regulation
- IVDR certification from TÜV SÜD enables broader adoption of
guideline-recommended genomic profiling to inform optimal therapy
selection for patients with advanced cancer
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology
company, today announced certification for its Guardant360® CDx
blood test under the European Union’s In Vitro Diagnostic
Regulation (IVDR 2017/746). The certification from TÜV SÜD Product
Service is for tumor mutation profiling in patients with any solid
cancerous tumor and for companion diagnostic indications to
identify patients who may benefit from certain targeted therapies
for advanced non-small cell lung cancer and breast cancer.
Under the previous EU regulatory framework (IVD Directive
98/79/EC), manufacturers were able to self-certify most of their
molecular assays. Under the IVDR most must obtain a conformity
assessment and certificate from an accredited company, called a
notified body, such as TÜV SÜD. Guardant360 CDx is a next
generation sequencing (NGS)-based assay that detects genomic
alterations using circulating tumor DNA from blood. The test allows
clinicians to use tumor mutation profiling, also known as
comprehensive genomic profiling (CGP), to identify somatic
mutations in solid tumors from a simple blood draw to inform
personalized treatment decisions for their patients with advanced
cancer.
“The IVDR certification for the Guardant360 CDx liquid biopsy is
a significant milestone for cancer care in the EU, as the test
provides faster access to comprehensive genomic profiling for
oncologists and, more importantly, for the patients they treat,”
said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “We are
confident that this certification will help accelerate wider
adoption of guideline-recommended genomic profiling, pave the way
for the development of new targeted therapies, and increase the
number of advanced cancer patients who receive potentially
life-changing treatments.”
More than 1.2 million people are predicted to die from cancer in
the EU in 2024,1 many of whom could benefit from comprehensive
genomic profiling to guide a more personalized treatment plan,
based on the growing availability of effective CGP-informed
targeted therapies. Clinical studies show that patients receiving
targeted therapies have improved progression-free survival and
higher overall response rates relative to chemotherapy or
immunotherapy.2-8
“Clinical adoption of targeted therapies lags behind medical
guidelines due to several factors, including insufficient tissue
for molecular profiling, which is the case for as many as 30
percent of solid cancer patients,” said Nicola Normanno, MD,
scientific director of IRCCS Romagna Institute for the Study of
Tumors (IRST) "Dino Amadori" in Meldola, Italy.9-11 “Expanding the
use of genomic profiling with IVDR-certified liquid biopsy will
help the cancer care community establish more clinically relevant
biomarkers to improve diagnosis and quickly identify the
personalized therapies that patients can benefit from.”
Under the IVDR, Guardant360 CDx is certified as a companion
diagnostic to identify patients with non-small cell lung cancer who
may benefit from treatment with TAGRISSO® (osimertinib), RYBREVANT®
(amivantamab), or LUMYKRAS® (sotorasib), and advanced breast cancer
patients with ESR1 mutations who may benefit from treatment with
ORSERDU™ (elacestrant).
Personalized medicines such as these have been life-changing for
many cancer patients who have targetable mutations and are thus
most likely to benefit from a particular therapy. IVDR
certification for Guardant360 CDx is significant because it ensures
continued broad access in the EU to comprehensive genomic
profiling, which plays a critical role in helping biopharma
companies identify patients to enroll in clinical trials and
helping oncologists match patients to new precision medicines that
target solid tumors.
“I am pleased that the new IVDR framework provides strict and
high quality standards for diagnostic tools, because this will
contribute to better standard of care and clinical trial
protocols,” said Peter Fasching, MD, professor of Obstetrics and
Gynecology and coordinator of the Breast Cancer Center and the
Gynecological Cancer Center at the Comprehensive Cancer Center
Erlangen-EMN, Germany. “Using IVDR-certified liquid biopsy more
broadly will allow us to find more biomarkers that can be targeted
in the future and gives clinicians confidence that they are using a
highly validated tool to select the optimal individualized
treatment plan for the patient.”
Since being introduced, the Guardant360 test has become widely
accepted for blood-based comprehensive genomic profiling, with more
than 400 peer-reviewed publications. It has been used by more than
12,000 oncologists, with more than 500,000 tests performed to
date.
About Guardant360 CDx
The first FDA-approved blood test for complete genomic testing,
Guardant360 CDx received U.S. FDA approval in August 2020 and CE
mark for tumor mutation profiling in March 2021. For oncologists,
the test provides comprehensive genomic results from a simple blood
draw in seven days, helping them move beyond the limitations of
tissue biopsies to rapidly obtain clinically relevant information
in time to match patients to the optimal personalized treatment.
Guardant360 CDx covers all genes recommended by the National
Comprehensive Cancer Network, including those most relevant to
clinical care and NSCLC treatment guidelines. For more information,
visit guardant360cdx.com.
About Guardant Health
Guardant Health is a leading precision oncology company focused
on guarding wellness and giving every person more time free from
cancer. Founded in 2012, Guardant is transforming patient care by
providing critical insights into what drives disease through its
advanced blood and tissue tests, real-world data and AI analytics.
Guardant tests help improve outcomes across all stages of care,
including screening to find cancer early, monitoring for recurrence
in early-stage cancer, and helping doctors select the best
treatment for patients with advanced cancer. For more information,
visit guardanthealth.com and follow the company on LinkedIn, X
(Twitter) and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of federal securities laws, including statements
regarding the potential utilities, values, benefits and advantages
of Guardant Health’s liquid biopsy tests or assays, which involve
risks and uncertainties that could cause the actual results to
differ materially from the anticipated results and expectations
expressed in these forward-looking statements. These statements are
based on current expectations, forecasts and assumptions, and
actual outcomes and results could differ materially from these
statements due to a number of factors. These and additional risks
and uncertainties that could affect Guardant Health’s financial and
operating results and cause actual results to differ materially
from those indicated by the forward-looking statements made in this
press release include those discussed under the captions “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operation” and elsewhere in its Annual
Report on Form 10-K for the year ended December 31, 2023, and any
current and periodic reports filed with or furnished to the
Securities and Exchange Commission thereafter. The forward-looking
statements in this press release are based on information available
to Guardant Health as of the date hereof, and Guardant Health
disclaims any obligation to update any forward-looking statements
provided to reflect any change in its expectations or any change in
events, conditions, or circumstances on which any such statement is
based, except as required by law. These forward-looking statements
should not be relied upon as representing Guardant Health’s views
as of any date subsequent to the date of this press release.
References
- https://pubmed.ncbi.nlm.nih.gov/38286716/
- Shaw AT, Riely GJ, Bang Y-J, et al. Crizotinib in
ROS1-rearranged advanced non-small-cell lung cancer (NSCLC):
updated results, including overall survival, from PROFILE 1001. Ann
Oncol. 2019;30(7):1121-1126.
- Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator
EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA):
Final overall survival analysis. Ann Oncol. 2019;30(5):
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- Garon EB, Hellmann MD, Costa EC, et al. Five-year long-term
overall survival for patients with advanced NSCLC treated with
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- Camidge DR, Dziadziuszko R, Peters S, et al. Updated Efficacy
and Safety Data and Impact of the EML4-ALK Fusion Variant on the
Efficacy of Alectinib in Untreated ALK-Positive Advanced Non–Small
Cell Lung Cancer in the Global Phase III ALEX Study. J Thorac
Oncol. 2019;14(7):1233-1243.
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Accessed March 1, 2021.
- Gadgeel SM, Garassino MC, Esteban E, et al. KEYNOTE-189:
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vs placebo plus chemo for metastatic nonsquamous NSCLC. J Clin
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- Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin
alone or with bevacizumab for non-small-cell lung cancer. N Engl J
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- Hagemann IS, Devarakonda S, Lockwood CM, et al. Clinical
Next-Generation Sequencing in Patients with Non–Small Cell Lung
Cancer. Cancer. 2015;121:631-639.
- Parsons HA, Beaver JA, Cimino-Mathews A, et al. Individualized
Molecular Analyses Guide Efforts (IMAGE): A Prospective Study of
Molecular Profiling of Tissue and Blood in Metastatic
Triple-Negative Breast Cancer. Cancer Res. 2017;23(2);
379–386.
- Wyatt AW, Annala M, Aggarwal R, et al. Concordance of
Circulating Tumor DNA and Matched Metastatic Tissue Biopsy in
Prostate Cancer. J Natl Cancer Inst. 2018;110(1):djx118.
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Investor Contact: Zarak Khurshid
investors@guardanthealth.com
Media Contact: Michael Weist press@guardanthealth.com +1
650-647-3643
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