Mammogen Unveils CLIA-Validated genTRU-breast for Breast Cancer Detection

Mammogen has achieved CLIA validation for genTRU-breast, a groundbreaking blood test for early Stage I breast cancer detection. Utilizing advanced qPCR technology to analyze mRNA profiles, it shows over 99% sensitivity and 89% specificity. Set for commercial launch in 2024, this test aligns with new MQSA regulations and opens a significant market in women's health, revolutionizing early breast cancer diagnosis.

Mammogen, has achieved Clinical Laboratory Improvement Amendments (CLIA) validation for its innovative plasma-based clinical assay, genTRU-breast. This assay is the first of its kind to facilitate the early detection of Stage I breast cancer through a blood test, marking a revolutionary step in breast health management.

Elizabeth Cormier-May, CEO of Mammogen, described this milestone as the highlight of her two-decade career in commercial diagnostics, emphasizing the assay's scientific, clinical, and social impact.

“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. 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.”

The Science of genTRU-breast

Employing advanced real-time qPCR technology, genTRU-breast focuses on detecting early-stage breast cancer with exceptional precision. The test analyses messenger RNA (mRNA) expression profiles of specific gene targets, enabling the identification of breast cancer at its most treatable stage. Unlike traditional methods that seek out circulating cancer cells, genTRU-breast leverages the dynamic response of the patient's body, reflecting parent company IVBH's emphasis on RNA-focused early detection.

Prior to its validation, genTRU-breast underwent extensive testing across six independent patient cohorts, involving over 500 patients, to guarantee accuracy and reliability.

Achieving CLIA Validation

The CLIA validation of genTRU-breast is a notable accomplishment, with the assay demonstrating more than 99% sensitivity and 89% specificity for Stage I breast cancer. Overall, its accuracy stands at an impressive 94.5%. These groundbreaking results, supported by AI and machine learning, are set to be presented at the 2023 San Antonio Breast Cancer Symposium and will feature in the Cancer Research journal later this year.

Impact and Future Plans

With CLIA validation in hand, Mammogen is on track to commercially launch genTRU-breast in the second half of 2024. This aligns with the upcoming implementation of the Mammography Quality Standards Act (MQSA) in September 2024. The MQSA addresses a critical need in breast health, and Mammogen anticipates tapping into a market opportunity ranging between $2.5 and $12 billion, with a total addressable market exceeding $35 billion in the U.S.