Elizabeth Cormier-May routinely spends $649 out of pocket twice a year for breast MRIs, and during years involving a biopsy, costs skyrocket to well over $10,000 just to navigate what should be a standard healthcare pathway. Having no family history of breast cancer but possessing extremely dense breasts, she is betting that other women facing similar hurdles will willingly pay $500 for a specialized breast cancer blood test rather than waiting for slow insurance approvals.

That bold strategy has successfully attracted major institutional backing. In June, the Newport Beach, California-based women’s health startup revealed a Series A financing round of up to $30 million, spearheaded by an unnamed major U.S. public retirement fund. This capital injection will directly finance a robust 2,600-woman clinical trial for its flagship genTRU-breast diagnostic test. Cormier-May co-founded Mammogen alongside Marty Keiser, founder of IVBH and the startup's chief operating officer.

Dense Breast Notifications Have Ignited Unmet Patient Demand

Since September 2024, federal mandates have required all mammography facilities to officially notify patients if they have dense breast tissue. Because nearly half of all women aged 40 and older undergoing mammograms have dense tissue—making tumors much harder to detect while simultaneously increasing cancer risks—Mammogen estimates that more than 38 million American women fall into this category.

While these mandatory letters advise women to consult a physician, they typically fail to specify which type of doctor to see or what diagnostic steps should follow. Standard procedures usually involve ultrasounds, MRIs, and frequent biopsies. Cormier-May noted that people often overlook the fact that MRIs were never originally designed to function as primary screening tools.

Meanwhile, the existing healthcare system remains heavily strained. Data from a Medicus Healthcare Solutions radiology staffing survey indicates that 79% of medical practices currently experience shortages of breast imaging radiologists. Cormier-May emphasized that the current radiological infrastructure simply cannot accommodate the massive volume of women with dense breasts. Consequently, she is actively collaborating with large radiology groups that view a reliable blood test as an efficient triage tool to determine which patients require immediate imaging—an application she initially had not anticipated until industry operators proposed it.

Bypassing High Deductibles With Direct Consumer Access

While most diagnostic startups structure their entire business models around insurance reimbursement, Cormier-May takes a different perspective, noting that even after diagnostics achieve coverage, patients still must clear hefty deductibles. Government and health data from 2023 shows that 41.7% of privately insured Americans under 65 were enrolled in high-deductible health plans.

To counter this, Mammogen plans to collaborate with national and regional insurers while simultaneously establishing direct partnerships that allow women to purchase the test out of pocket. Relying solely on standard reimbursement models can force companies to wait 24 to 48 months before generating recognizable revenue. Direct-to-consumer sales accelerate revenue recognition within the diagnostics lifecycle, proving that patients are willing to pay directly for definitive answers.

Cormier-May highlights GRAIL as a prime precedent. Although its Galleri multi-cancer screening test lacks FDA approval, GRAIL reported $44.7 million in revenue during the second quarter of 2026, with approximately 70% of Galleri test volume driven by self-pay customers. In her view, GRAIL demonstrated that a blood-based cancer diagnostic can successfully enter the market without broad insurance coverage or prior FDA approval. Galleri currently lists at around $949, nearly double Mammogen’s anticipated price point.

Dr. Robert S. Epstein, a former chief medical officer at Medco who joined Mammogen as an independent board member in October, believes effective execution will be the ultimate test. He remarked that innovation alone does not transform healthcare, requiring strong leadership and discipline to translate novel concepts into meaningful clinical outcomes.

What a Public Pension Fund Sought From a Women’s Health Venture

Securing up to $30 million led by a public retirement system followed nearly a year of intensive due diligence—a process Cormier-May describes as far more flexible and adaptive than conventional venture capital agreements. Prior to this milestone round, Mammogen had raised roughly $3 million.

The institutional investor subjected the startup to nearly a year of scrutiny, marking the most rigorous evaluation of Cormier-May's entrepreneurial career. The fund, which invests across multiple sectors with a heavy healthcare emphasis, evaluated three core criteria before assessing the underlying science: potential societal impact, overall market size, and whether the executive team had a proven track record of successful exits. Cormier-May estimates the total U.S. market for her test reaches $19 billion annually at a $500 price point.

While the scientific audit mirrored traditional venture capital evaluations, the key differences lay in the investment timeline and customized deal structures. Although declining to name the investor or disclose specific financial terms, she praised the framework as highly progressive and well-suited for the modern diagnostics industry. She added that knowing the capital originates from hardworking pension contributors deepens her personal sense of responsibility to ensure the venture succeeds.

Clinical Validation and the Road Ahead for GenTRU-Breast

The genTRU-breast diagnostic analyzes 26 messenger RNA markers in the bloodstream—some representing the body's immunological reaction to cancer and others shed directly by tumors—to deliver a clear yes-or-no result. Retrospective studies encompassing approximately 600 women yielded sensitivity and negative predictive values approaching 99%, figures derived from internal analyses of patients with pre-established diagnoses.

The upcoming prospective evaluation, designated as the KATELYN-ERIN trial, will be led by Dr. Rebecca D. Kaltman, executive director of the Inova Saville Cancer Screening and Prevention Center. This study will enroll roughly 2,600 women scheduled for image-guided biopsies, comparing individual blood assay results against pathology outcomes while categorizing data by breast density. Dr. Kaltman commended Cormier-May's dedication to prospective clinical validation and her focus on integrating novel biologic tools seamlessly alongside traditional imaging modalities.

Even exceptional clinical data will not transform medical practices overnight. Cormier-May anticipates that physicians will rigorously test the test, running it alongside conventional biopsies for six to twelve months before fully trusting negative findings, mirroring the adoption curve seen with prostate cancer blood screenings. Following the clinical trial, Mammogen intends to launch genTRU-breast as a laboratory-developed test while actively pursuing breakthrough device designation from the FDA.

Strategic Takeaways for Diagnostics Entrepreneurs

Mammogen’s commercial roadmap offers three vital lessons for fellow founders: pricing diagnostics around patient deductibles rather than static insurance billing codes, identifying secondary target markets like radiology practices facing severe staffing shortages, and securing backing from investors whose funding timelines align with diagnostics requiring large-scale trials.

Ultimately, these strategies hinge entirely on whether the KATELYN-ERIN trial successfully replicates past retrospective results. Cormier-May views the mission through a deeply personal lens, noting that nothing about her own medical journey is abnormal aside from her classification as category D for extreme breast density.