Lynx Dx's Biomarker Test Offers Market-Leading
Accuracy in Prostate Cancer Risk Assessment
ANN
ARBOR, Mich., April 18,
2024 /PRNewswire/ -- Lynx Dx, a leader in
innovative diagnostic solutions, hailed new peer-reviewed research
published today in the Journal of the American Medical
Association (JAMA) Oncology that validates the efficacy of
MyProstateScore 2.0 (MPS2), the company's groundbreaking prostate
cancer risk assessment test. The findings signify a major
advancement in the ability to make highly accurate, comprehensive
and personalized predictions by raising the performance standard
for urine biomarker tests intended to detect clinically significant
prostate cancer.
Unmet Need
Prostate cancer is the most common cancer and the second leading
cause of cancer death in American men, affecting nearly one in
eight. The prostate specific antigen (PSA) blood test has long been
considered the gold standard for early detection of prostate
cancer, but because PSA levels can be elevated for many unrelated
reasons, it offers an incomplete picture. Further, more than 75% of
men with an elevated PSA will have a biopsy negative for clinically
significant cancer.
Clinical Validation
In the clinical validation of MPS2 published in JAMA
Oncology, scientists evaluated whether MPS2 could improve
prostate cancer screening outcomes relative to existing
biomarkers.
Key findings from the paper include:
- MPS2 was clinically validated separately in patients presenting
for initial biopsy (i.e., biopsy naïve) and those presenting for a
repeat biopsy (i.e., prior negative biopsy).
- Use of the test would safely identify 42% to 51% of patients
who would not have clinically significant prostate cancer found on
biopsy, while maintaining high sensitivity for high-grade
cancers.
- The test was validated for use as a biomarker-only test or
inclusive of optional clinical risk factors.
- The test performed significantly better compared to existing
biomarker tests.
The research was funded by the Michigan-Vanderbilt Early
Detection Research Network Biomarker Characterization Center (grant
U2C CA271854) and the Early Detection Research Network Data
Management and Coordinating Center (EDRN) (grant U24 CA086368).
Study analysis and validation occurred in the EDRN.
"The research findings confirm the role of MPS2 to guide a more
informed decision about whether to proceed with a prostate biopsy –
a decision that is notoriously difficult to get right," said Lynx
Dx Chief Medical Officer Spencer
Heaton, MD, MBA. "Lynx Dx's goal is to provide best-in-class
diagnostic tests that enable urologists and patients to make
confident decisions, while greatly improving the rate of
life-saving early detection."
MPS2
MPS2 is a urine test designed to predict the presence of
clinically significant prostate cancer by analyzing expression of
18 unique gene transcripts. The test optimizes diagnostic
accuracy for both biopsy naïve patients and those with a prior
negative biopsy. Additionally, it provides diagnostic flexibility
with optional assessment of personalized risk factors known to
influence the development of clinically significant prostate
cancer.
Lynx Dx has an exclusive license from the University of Michigan to commercialize the
groundbreaking science that is the foundation for MPS2.
The paper's first authors are Jeffrey J. Tosoian, M.D.,
M.P.H., who is now at Vanderbilt
University, and Yuping Zhang,
Ph.D., and Lanbo Xiao, Ph.D., at
U-M. Additional authors are Cassie
Xie; Nathan L. Samora, M.D.;
Yashar S. Niknafs, Ph.D.;
Zoey Chopra; Javed Siddiqui; Heng Zheng, M.D.; Grace Herron; Neil
Vaishampayan; Hunter S.
Robinson, M.D.; Kumaran Arivoli; Bruce J. Trock, Ph.D.; Ashley E. Ross, M.D., Ph.D.; Todd M. Morgan, M.D.; Ganesh S. Palapattu, M.D.;
Simpa S. Salami, M.D., M.P.H.; Lakshmi P. Kunju, M.D.; Scott A. Tomlins, M.D., Ph.D.; Lori J. Sokoll, Ph.D.; Daniel W. Chan, Ph.D.; Sudhir Srivastava, Ph.D.; Ziding Feng, Ph.D.;
Martin G. Sanda, M.D.; Yingye Zheng,
Ph.D.
Funding for this work is from the Michigan-Vanderbilt Early
Detection Research Network Biomarker Characterization Center and
Data Management and Coordinating Center, which are through the
National Cancer Institute grants U2C CA271854 and U24 CA086368.
Additional funding is from NCI grants P50 CA186786, R35 CA231996,
U24 CA115102, U01 CA113913; Prostate Cancer Foundation; Howard
Hughes Medical Institute; and the American Cancer Society. Any
mention of specific products, services, companies or organizations
does not imply endorsement by these organizations.
Disclosures: Chinnaiyan serves on the advisory boards of Tempus,
Lynx Dx, Ascentage Pharmaceuticals, Medsyn therapeutics, Esanik and
RAAPTA therapeutics. Tomlins is an equity holder and chief medical
officer of Strata Oncology. Lynx Dx has obtained an exclusive
license from the University of Michigan
to commercialize MPS2 and the TMPRSS2-ERG gene fusion. Tosoian and
Chinnaiyan are equity holders and scientific advisers to Lynx Dx.
Siddiqui, Zhang, Xiao and Niknafs have served as scientific
advisers to Lynx Dx.
Paper cited: "Development and Validation of an 18-Gene
Urine Test for High-Grade Prostate Cancer," JAMA Oncology.
doi:10.1001/jamaoncol.2024.0455
About Lynx Dx
Using technology developed at the University of Michigan, Lynx Dx provides
best-in-class diagnostic testing services to help people live
healthy and productive lives. The company's mission is to develop
superior genomic tests where there is clear patient need. Lynx Dx
produces tests with the highest degree of accuracy and efficiency
combined with an unparalleled customer experience. For more
information about Lynx Dx and MyProstateScore 2.0, please visit
www.lynxdx.com.
Media Contact
Stephanie
Fraser
public.relations@lynxdx.com
734-233-1483
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