Mammogen Taps Imaging Leader to Advance RNA-Based Breast Cancer Test

NEWPORT BEACH, Calif. – June 24, 2026 – Predictive health company Mammogen has appointed Dr. Elise Berman, a renowned physician executive and breast imaging leader, as its new Chief Medical Officer. The move signals a pivotal moment for the female-led firm as it prepares to commercialize genTRU-breast™, a novel RNA-based blood test designed to revolutionize early breast cancer detection. Coming on the heels of a $30 million Series A financing round, Dr. Berman’s appointment is a strategic play to accelerate the technology’s path from clinical validation to market adoption, with a sharp focus on addressing one of modern screening’s most persistent challenges: detecting cancer in women with dense breast tissue.

A Strategic Bridge Between Imaging and Molecular Biology

Dr. Berman joins Mammogen from a distinguished career spanning more than two decades, where she has been at the forefront of breast cancer diagnostics. Her experience provides a unique bridge between the established world of radiological imaging and the emerging frontier of molecular biology. For 22 years, she was a leader at Fairfax Radiological Consultants (FRC), one of the nation's largest private radiology practices. There, as Medical Director and Chief of Breast Imaging, she was instrumental in building a premier breast imaging program, establishing one of the region’s first and largest breast MRI programs, and leading a dedicated team of specialists.

More recently, she served as Chief Medical Officer at Delphinus Medical Technologies, where she led clinical development for an FDA-approved breast imaging platform specifically designed for women with dense breasts. This deep, practical expertise in the limitations of traditional imaging is precisely what makes her a critical asset for Mammogen.

“Elise brings together breast cancer detection expertise, diagnostic development experience, and proven clinical leadership,” said Elizabeth Cormier-May, Chief Executive Officer of Mammogen. “She has spent her career evaluating and advancing technologies designed to improve breast cancer detection and understands both the strengths and limitations of imaging alone. Bringing her in to lead our clinical strategy is a defining moment for the company and an important step forward in our mission.”

Dr. Berman, who previously served as a senior medical advisor to Mammogen, shaping its clinical trial design, echoed this sentiment. “For women with dense breasts and others at elevated risk, imaging alone does not always provide a clear path forward,” she stated. “Despite remarkable advances, clinicians still have limited biologic information to help guide breast cancer detection. Mammogen is developing a new approach designed to bring molecular biology into the breast diagnostic pathway.”

The Science Behind genTRU-breast™

Mammogen’s genTRU-breast™ is not just another diagnostic test; it represents a fundamental shift in approach. It is a blood-based assay that utilizes real-time quantitative Polymerase Chain Reaction (qPCR) to analyze cell-free RNA (cfRNA) in a patient's plasma. Unlike many liquid biopsies that focus on cell-free DNA (cfDNA), which often requires significant tumor shedding to be detectable, cfRNA provides a more dynamic, real-time snapshot of the body's active biological processes. This includes signals from both the tumor itself and the body's systemic response to the disease, potentially enabling detection at a much earlier stage.

The test is designed to act as a non-invasive triage tool. Following a standard mammogram that identifies a woman as having dense breast tissue, the genTRU-breast™ test can provide a clinically actionable biological signal. This can help physicians guide patients toward the most appropriate next step, potentially avoiding unnecessary and often anxiety-inducing follow-up imaging like ultrasounds or MRIs, which have high false-positive rates. For patients with a high-risk signal, it can accelerate the path to more definitive diagnostic procedures.

In extensive clinical validation studies across six independent patient cohorts totaling over 500 patients, the technology has shown remarkable promise. The results, presented at the 2023 San Antonio Breast Cancer Symposium, demonstrated over 99% sensitivity and 89% specificity for detecting Stage I breast cancer, with an overall accuracy of 94.5%. This level of precision in early-stage detection is a significant step toward improving patient outcomes.

Addressing the Dense Breast Dilemma

The market need for a solution like genTRU-breast™ is both vast and urgent. Nearly half of all women in the U.S. over 40—more than 38 million—have dense breast tissue. This condition not only increases a woman’s risk of developing breast cancer but also severely compromises the effectiveness of mammography. The dense, fibrous tissue appears white on a mammogram, the same color as potential tumors, creating a “masking effect” that can cause cancers to be missed. The sensitivity of mammography can drop from 93% in fatty breasts to as low as 30% in extremely dense breasts.

This challenge is now at the forefront of public health policy. In September 2024, a new federal mandate under the Mammography Quality Standards Act (MQSA) will require all U.S. imaging centers to notify women if they have dense breasts. This regulation is expected to create a surge in demand for reliable supplemental screening tools. Mammogen is strategically timing its commercial launch of genTRU-breast™ as a Laboratory Developed Test (LDT) for the second half of 2024 to meet this anticipated need.

Funding Growth and Navigating the Market

Mammogen’s ambitious plans are backed by significant financial and strategic support. The recently closed $30 million Series A round was led by a major, undisclosed U.S. public retirement system, providing the capital necessary to fund a pivotal prospective clinical study and scale commercial operations. This funding builds on the company’s foundation within the IV BioHoldings (IVBH) ecosystem, a bio-innovation studio designed to industrialize biology and accelerate the development of early detection technologies.

The LDT pathway allows Mammogen to bring genTRU-breast™ to market relatively quickly by leveraging existing CLIA-certified laboratories. The company aims for an accessible price point at or below $500, a fraction of the cost of many advanced cancer diagnostics. While the competitive landscape for liquid biopsies is intensifying, with players like Exai Bio and others also exploring RNA-based technologies, Mammogen’s specific focus on the dense breast population and its integration as a triage tool alongside existing imaging provides a distinct market position. The leadership of Dr. Berman, with her deep understanding of clinical workflows and regulatory pathways, will be crucial in navigating this complex market, driving physician adoption, and ultimately securing reimbursement to ensure broad patient access.