Mammogen Achieves CLIA Validation of gen-TRU-breast™ Assay

World's First Early Detection Blood Test to Unlock Stage I Diagnosis of Breast Cancer

NEWPORT BEACH, Calif., Nov. 15, 2023 /PRNewswire/ -- Mammogen, a leader in women's health and bellwether subsidiary of early detection parent company IVBH, has announced the successful completion of Clinical Laboratory Improvement Amendments (CLIA) validation for its pioneering plasma-based clinical assay, genTRU-breast, a test designed to detect the earliest stages of breast cancer. This achievement represents a momentous step forward in revolutionizing breast health. 

The Science Behind genTRU-breast

genTRU-breast, a state-of-the-art real-time qPCR assay, is designed to detect early-stage breast cancer with unparalleled precision. This assay hinges on the quantification of messenger RNA (mRNA) expression profiles of proprietary gene targets, offering a powerful tool for the identification of breast cancer at its earliest, most treatable stages. The technology is based on the dynamic response of the patient, as opposed to the detection of circulating cancer cells — a hallmark of parent company IVBH's RNA-focused early detection platform.

Since the inception of the program, genTRU-breast has been extensively validated across six independent patient cohorts, totaling over 500 patients, to ensure the utmost accuracy and reliability in its results.

CLIA Validation: A Landmark Achievement

In CLIA validation, leveraging proprietary AI/ML, the genTRU-breast clinical assay achieved a statistically significant >99% sensitivity, 89% specificity in stage I breast cancer (p<0.001), with an overall accuracy reported at 94.5%. These peer-reviewed data were accepted for a poster presentation at the upcoming 2023 San Antonio Breast Cancer Symposium and selected for publication in Cancer Research later this year.

"After two decades effecting change in commercial diagnostics, this achievement is the brightest spot of my career, with a profound culmination of scientific, clinical, and social impact," stated Mammogen CEO, Elizabeth Cormier-May.

"From the beginning, Mammogen has been steadfast in our commitment to unlocking the quality-of-life preservation that exists in the earliest stages of breast cancer and being a true partner to the patients that we serve, from end-to-never-end. This unprecedented data changes everything for our community and solidifies Mammogen as the leader in accurate, affordable, scalable, and socially responsible diagnostics in women's health. We look forward to publishing and presenting this breakthrough achievement at San Antonio and accelerating this paradigm-shifting technology to market."

Commercialization and Market Impact

With CLIA validation of this assay now complete, Mammogen will work diligently to commercially launch genTRU-breast in 2H 2024, a timeline aligned with the nationwide implementation of the Mammography Quality Standards Act (MQSA). This federal regulation, set to take effect in September 2024, defines a major unmet clinical need in breast health. According to management, the MQSA ruling unlocks an estimated $2.5 billion to $12 billion in immediate market opportunity and a total addressable market exceeding $35 billion (US).

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About Mammogen

Mammogen is a female-led precision diagnostics company dedicated to radically improving the detection, diagnosis and treatment of diseases that affect some, mostly or only women. Our flagship liquid detection program, genTRU-breast, is a CLIA validated PCR-based gene expression blood test designed to detect breast cancer in the earliest stages. The genTRU-breast assay is anticipated to launch commercially as a laboratory developed test (LDT) in 2H 2024. For more information visit mammogen.bio.

About IVBH

IVBH is the world's first disease-agnostic AI-powered early detection platform, conceiving, creating and internally developing first-in-class blood tests that detect your body's response to disease in the earliest possible stages. Our mission is to unlock the quality-of-life preservation that exists at stage zero through highly accurate, affordable, and accessible diagnostic solutions, for all of humanity, at scale. For more information visit ivbh.studio.

SOURCE Mammogen