Mammogen raises up to $30M to advance RNA blood test for early breast cancer detection

The Newport Beach, California diagnostics company Mammogen has raised up to $30 million in Series A financing led by a major U.S. public retirement system to advance genTRU-breast. The technology is an RNA-powered blood test for earlier breast cancer detection in women with dense breast tissue, where mammograms are harder to read and patients often cycle through repeat ultrasounds, MRIs and biopsies.

The aim of detecting breast cancer at stage 1

The company is positioning genTRU-breast as a triage tool after mammography identifies dense breast tissue. Elizabeth Cormier-May, CEO of Mammogen, said the test is intended to help separate women who should move quickly to MRI or biopsy from those who may be able to avoid some additional imaging. “They just know they’re seeing something. It could be cancer, could be calcification, could be a cyst,” she said of MRI and ultrasound findings. “That’s why we end up in breast biopsy, and thankfully the vast majority of us have negative biopsies.”

The test is designed to add molecular information after a mammogram flags dense tissue, the point where imaging gets more difficult to read because dense tissue and tumors can both appear white on the scan. “We do not want to supplant mammography, because it gives us important information, first and foremost our breast density category,” Cormier-May said.

A low result lets a woman avoid some of the supplemental imaging she would otherwise cycle through and likely avoids an unnecessary biopsy, Cormier-May said, while a high result would send her to MRI to look for and characterize a suspected cancer before biopsy. “That test can help us decide what comes next,” she said. “The biggest difference we make by detecting disease early is offering optionality in treatment.” For a patient with cancer, “that could be everything from needing a mastectomy to not needing one, because we caught it at stage 1 or earlier,” she said.

Beyond surgical choices, Cormier-May emphasized that early detection grants women a window of time. Catching the disease early allows patients of childbearing age the opportunity to consult with reproductive endocrinologists, and gives all women the time to seek second opinions or research reconstructive surgery options.

An underserved market and a costly diagnostic pathway

Roughly half of women have dense breast tissue, where dense tissue and tumors both read as white on a mammogram and the scan can miss cancer up to 70% of the time in women with extremely dense breasts, by Cormier-May’s account. In 2023 the FDA finalized breast density notification requirements under the Mammography Quality Standards Act, with enforcement beginning in September 2024, so for the first time under a national federal standard, imaging centers must tell a woman when her breasts are dense. That mandate created a large, newly informed population facing the same next question: now what? The current answer routes them into supplemental ultrasound, MRI and, frequently, biopsy, a pathway Cormier-May pegged at $11 billion a year, most of those biopsies coming back negative.

A decentralized trial and a balance-sheet investor

The round backs what Cormier-May described as an IRB-approved pivotal study already underway, with the new money meant to ramp enrollment. The “hybrid decentralized” design lets Mammogen enroll women through the usual radiology centers and hospital networks and also outside them, sending phlebotomists to a participant’s home so she never has to route through a physician or sit in a lab.

Beyond the trial, Cormier-May said the capital goes toward market preparation and a set of clinical and commercial partnerships. The company plans to run the test through existing CLIA-certified lab infrastructure and is targeting a price at or below $500, a fraction of the $3,000 to $5,000 Cormier-May said is typical of cancer diagnostics.

In 2023, Mammogen announced it received CLIA validation of the assay, which the company said had been tested across six independent cohorts totaling more than 500 patients. The pivotal trial now enrolling is the prospective step meant to confirm those results.

Before the Series A, Mammogen had raised roughly $3 million in prior capital (a $2 million seed in 2021 plus $1 million from parent IVBH). Cormier-May described the new lead investor, a public retirement system with more than $100 billion under management, as a balance-sheet partner.

Marty Keiser, IVBH’s founder and Mammogen’s chief operating officer, framed the cash infusion in mission terms. “It’s the fuel we need for the rocket to actually shoot for the moon,” he said. “A lot of promising early science never reaches market because it lacks the capital and the ability to grow, scale, and support it.”