Publications describe foundational technology
and the verification of the Mercy Halo™ ovarian cancer screening
test
WALTHAM,
Mass., Sept. 30, 2024 /PRNewswire/ -- The
Journal of Molecular Diagnostics has published two companion papers
describing a novel technology platform and clinical verification of
an ovarian cancer test based on the platform from Mercy
BioAnalytics, Inc., a pioneer in blood-based detection of
early-stage cancer.
Only a handful of cancer screening tests have been broadly
adopted because of the high performance bar that must be achieved.
Tests must be sensitive enough to detect nearly all cancers but
specific enough to protect against unnecessary anxiety and
intervention. Additionally, test costs must be low enough to enable
routine screening of the entire at-risk population. Mercy
BioAnalytics has embraced these challenges, and these publications
provide compelling preliminary evidence of significant progress
toward the development of a safe and effective ovarian cancer
screening test for postmenopausal women, the group most affected by
the disease.
The Mercy Halo Technology Platform
The first publication, "Colocalization of cancer-associated
biomarkers on single extracellular vesicles for early detection of
cancer" details Mercy's groundbreaking technology platform.
Mercy's key insight is that tumor-derived extracellular vesicles
(EVs) are among the most abundant biomarkers in the blood, offering
significant advantages for detecting early-stage cancers compared
to lower-abundance markers like circulating tumor DNA. By measuring
co-localized membrane proteins on the surface of these
tumor-associated EVs, the platform enables a highly sensitive and
specific determination of cancer presence or absence. The
combination of a simple assay design and a qPCR readout also
enables low-cost testing. This innovative combination of features
allows the Mercy Halo platform to achieve the high performance and
broad accessibility required for a population-wide cancer screening
test. Mercy has used this foundational technology platform to
generate promising clinical data for the early detection of ovarian
cancer, reported in a second companion paper.
Clinical Verification of The Mercy Halo Platform for Ovarian
Cancer Screening
Ovarian cancer is one of the leading causes of cancer-related
death among women, with nearly 13,000 deaths expected in the U.S.
this year. More than 80% of ovarian cancer cases are diagnosed in
women 50 and older, and nearly 75% are detected at an advanced
stage, where survival rates are poor. The majority of deaths are
linked to high-grade serous carcinoma (HGSC), making early
detection of this subtype especially critical. Given the low
incidence and high mortality of ovarian cancer, any screening test
must be both highly sensitive and highly specific to be
effective.
Despite decades of research, no test has demonstrated the
necessary sensitivity and specificity to merit broad use in ovarian
cancer screening. CA125 serum biomarker testing and transvaginal
ultrasound imaging frequently miss early-stage ovarian cancers and
often produce false positives, incorrectly classifying healthy
women as potentially having cancer, leading to unnecessary and
invasive diagnostic procedures.
The second publication, titled "Improving specificity for
ovarian cancer screening using a novel extracellular vesicle-based
blood test – Performance in a training and verification cohort"
demonstrates that the Mercy Halo technology can detect HGSC with
both high sensitivity and specificity. Mercy's test offers the
potential for significant improvement over existing approaches and
may be suitable for ovarian cancer screening.
A HGSC case-control training clinical sample set from 397 women
obtained from the Ontario Tumor Bank (OTB) and the Ovarian Cancer
Research Program (OVCARE) was used to lock down the test design,
the data interpretation algorithm, and establish the cut-off
between cancer and non-cancer in the Mercy Halo assay. Test
performance was then verified in an independent blinded
case-control study with 390 serum samples obtained at diagnosis
from the MRC Clinical Trials Unit (CTU) at UCL UK Ovarian Cancer
Population Study (UKOPS) biobank. In the verification study, the
test showed 97.0% specificity, 97.0% HGSC sensitivity, and an AUC
of 0.97. This included a sensitivity of 84.6% for stage I and 100%
for stage II, with a specificity of 97%. Compared to CA125, this
test produced fewer false positives in patients with benign ovarian
tumors, non-ovarian cancers, and inflammatory conditions,
suggesting it may be a promising tool for ovarian cancer
screening.
"These two seminal publications mark a significant step forward
in our efforts to reduce suffering and save lives through the early
detection of cancer." said Dawn
Mattoon, Ph.D., Mercy's Chief Executive Officer. "They
validate the incredible potential of our Mercy Halo technology
platform and demonstrate our dedication to improving patient
outcomes, starting with ovarian cancer."
"The superior performance of the Mercy Halo test in comparison
to serum CA125 is promising. We look forward to further evaluation
of the test using samples prior to clinical diagnosis from the
United Kingdom Collaborative Trial of Ovarian Cancer Screening
(UKCTOCS)," said Professor Usha
Menon at MRC CTU at UCL, Chief Investigator of UKCTOCS.
These articles are available online at the Journal of Molecular
Diagnostics (paper 1 here and paper 2 here) and will be featured in
an upcoming print issue.
About Mercy BioAnalytics
Mercy BioAnalytics, Inc. is
on a mission to relieve suffering and save lives through the early
detection of cancer. Early-stage cancer is difficult to detect, but
when found, is more often amenable to curative therapy. The
patented Mercy Halo™ liquid biopsy platform utilizes biomarker
co-localization to interrogate highly abundant, blood-based
extracellular vesicles that carry unique cancer signatures from
their parent cells. The Mercy Halo platform is designed to detect
early-stage cancer, when it is most treatable, and enhance the
quality of life for cancer patients and their families. Mercy's
initial focus is the early detection of ovarian and lung cancers.
Ovarian cancer, the most lethal gynecological cancer, typically
goes undetected until it is too late to cure. Lung cancer, the
number one cancer killer, takes more lives than breast and prostate
cancers combined.
About Medical Research Council Clinical Trials Unit at
University College London
The MRC CTU at UCL is at the
forefront of resolving internationally important questions in
infectious diseases and cancer and delivering swifter and more
effective translation of scientific research into patient benefits.
It does this by carrying out challenging and innovative studies,
and developing and implementing methodological advances in study
design, conduct and analysis.
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SOURCE Mercy BioAnalytics