Mercy Halo™ Test demonstrates 82% sensitivity
and 98% specificity in a retrospective blinded analysis of
prospectively collected samples from 1300 asymptomatic
women
WALTHAM, Mass., May 23, 2024 /PRNewswire/ -- Mercy BioAnalytics,
Inc., a pioneer in extracellular vesicle-based liquid biopsy for
the early detection of cancer, will present data at the American
Society of Clinical Oncology Annual Meeting next month
demonstrating the first significant improvement in the early
detection of ovarian cancer using a locked assay since CA125 serum
biomarker testing and transvaginal ultrasound imaging were
introduced nearly 40 years ago. In a large blinded, retrospective
analysis of prospectively collected samples from more than 1,300
asymptomatic postmenopausal women, the Mercy Halo™ test
detected 82% of high grade serous ovarian cancer (HGSC) cases up to
one year prior to diagnosis with 98% specificity.
Mercy, in collaboration with the team at the Medical
Research Council Clinical Trials Unit (MRC CTU) at University
College London (UCL), analyzed samples from the UK Collaborative
Trial of Ovarian Cancer Screening (UKCTOCS) in which over 200,000
women were enrolled, randomized to no screening or annual
screening, and followed for up to 20 years. All trial participants
donated a blood sample at the time of enrollment. Mercy analyzed
blood samples from trial participants to assess the sensitivity and
specificity of the Mercy Halo test for detecting ovarian cancer up
to three years prior to clinical diagnosis.
Despite decades of effort, no test method has demonstrated the
sensitivity and specificity to merit broad use in screening. CA125
serum biomarker testing and transvaginal ultrasound imaging fail to
detect many early-stage ovarian cancers and too often incorrectly
classify healthy women as potentially having cancer, resulting in
unnecessary diagnostic workup. In this study, Mercy Halo
outperformed CA125 in both the ability to detect HGSC (82% vs 63%)
and specificity (98% vs 96%), significantly increasing the number
of cancers identified, and reducing the number of false positives
by almost half.
"This breakthrough is a testament to Mercy's dedication to the
development of innovative approaches to early cancer detection,"
said Mercy BioAnalytics Board Chair Stanley
Lapidus, a longtime life sciences executive whose
innovations helped revolutionize colorectal and cervical cancer
screening in the U.S. through founded companies including Exact
Sciences and Cytyc. "These highly encouraging results suggest the
Mercy Halo test may finally address this major unmet need and
potentially save many lives."
Ovarian cancer is one of the leading causes of cancer death
among women and will kill nearly 13,000 women in the U.S. this
year. More than 70% of ovarian cancer is diagnosed in women over 50
years of age, and nearly 80% of ovarian cancer is diagnosed at an
advanced stage of disease, when survival is poor. Unfortunately,
legacy diagnostic test methods have not shown adequate clinical
performance to enable broad adoption for ovarian cancer
screening.
The Mercy Halo test achieves high performance through the
simultaneous detection of multiple cancer-related biomarkers
co-localized on the surface of individual tumor-associated
extracellular vesicles. The high abundance of extracellular
vesicles in circulation enables the Mercy Halo test to be run on a
very small volume of serum or plasma with a simple qPCR-based
read-out, unlike cell-free DNA-based tests which typically require
a larger volume of blood and next-generation sequencing to generate
results.
"One in 78 women will develop ovarian cancer in her lifetime,
and today most of these women will die from their disease. Early
detection creates an opportunity to change this paradigm." said
Dawn Mattoon, Ph.D., Mercy's Chief
Executive Officer. "Mercy has made rapid progress developing high
quality, low-cost tests for cancer screening, and this study brings
us closer to the day when we can provide women with another
effective tool to help proactively manage their health."
"The superior performance of the Mercy Halo test in comparison
to serum CA125 in this initial study is promising, given the rigor
of evaluation and the use of the best possible CA125 cut-off for
this population, unlike previous studies. We look forward to
working with Mercy to further evaluate the test using samples from
the multimodal screening arm of UKCTOCS," said Professor
Usha Menon at MRC CTU at UCL, Chief
Investigator of UKCTOCS.
The Mercy ovarian cancer data will be shared on June 3rd in a poster titled "Evaluation of a
novel extracellular vesicle (EV) based ovarian cancer (OC)
screening test in asymptomatic postmenopausal women." The abstract
is available today on ASCO's website.
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
Stage I 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.
UKCTOCS
UKCTOCS is the largest ovarian cancer
screening trial to date. Over 200,000 eligible postmenopausal women
from the general population, aged 50–74 years, with intact ovaries
were recruited between 2001 and 2005 and randomly allocated (2:1:1)
to no screening or annual screening (multimodal screening or
ultrasound screening) until Dec 31,
2011. Follow-up was through national registries until 2020.
There was no reduction in deaths due to ovarian cancer in either
screening arms compared to no screening. However, in the multimodal
screening arm, fewer women with high grade serous ovarian cancer
were diagnosed with advanced stage disease and had improved
short-term outcomes. While the trial findings do not support
ovarian cancer screening using CA125 and ultrasound, they suggest
that novel approaches that can detect more women earlier in the
course of the disease are likely to positively impact
mortality.
CONTACT: Josh Gralapp, josh.gralapp@mercybio.com
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SOURCE Mercy BioAnalytics