Mammogen and MammoLink Partner to Advance a New Model for Community-Based Breast Cancer Detection
MammoLink joins Mammogen’s KATELYN-ERIN trial, expanding community access to a prospective study evaluating blood-based RNA biology for breast cancer detection
NEWPORT BEACH, Calif., Oct. 27, 2026 (GLOBE NEWSWIRE) — Mammogen, a predictive health company pioneering blood-based RNA diagnostics for women’s health, today announced a clinical research partnership with MammoLink, a specialized women’s health imaging provider founded by breast imaging radiologist Dr. Ryan Polselli. The partnership will bring Mammogen’s KATELYN-ERIN trial into communities across Florida through MammoLink’s mobile 3D mammography network, pairing molecular biology with an infrastructure built to move breast care closer to the women it serves.
Mammogen’s genTRU-breast™, a blood-based RNA assay, has demonstrated strong Stage I breast cancer detection performance in earlier clinical studies. KATELYN-ERIN now moves that science into a prospective study of approximately 2,600 women, evaluating assay performance against biopsy-confirmed pathology within the real-world breast care pathway. The KATELYN-ERIN trial is named in honor of Katy Shea-Butts, whose breast cancer diagnosis at age 29 helped inspire Mammogen’s founding mission to develop blood-based tools for earlier cancer detection.
MammoLink brings a unique community-based perspective to this work. Its mobile network of six 3D mammography units across Florida is designed to bring breast imaging closer to women in their communities. Through KATELYN-ERIN, the partnership will evaluate genTRU-breast while exploring a future in which blood-based biology could complement imaging to make breast cancer detection more accessible and actionable.
“The science behind genTRU-breast has demonstrated promising, powerful signals of breast cancer at its earliest stages. KATELYN-ERIN is about taking that science into the real world, at scale,” said Elizabeth Cormier-May, Chief Executive Officer of Mammogen. “At the heart of our approach is dual-source RNA biology, allowing us to interrogate signals from both the tumor and the host response to disease. Imaging tells us what we can see, while biology tells us what is happening in real time. Bringing those two dimensions together could fundamentally expand what we know about a woman’s breast health, particularly when density limits what mammography alone can reveal.”
That distinction is particularly important for women with dense breasts, where density can make cancers more difficult to detect on mammography. Today, clinicians largely rely on anatomical information to determine what can be seen and whether additional evaluation is warranted. Adding a biological layer to that care pathway creates the potential to assess disease from an entirely different dimension, one that is not constrained by breast density, and could provide meaningful new information alongside imaging to support clinical decision-making.
“Our mission has always been to save lives by making advanced breast imaging easier for women to access,” said Dr. Ryan Polselli, Founder of MammoLink. “Mammogen widens the reach of that vision. If we can bring imaging closer to women and ultimately layer meaningful biological information into that same experience, we have an opportunity to make the breast care journey simpler and potentially far more powerful.”
Together, Mammogen and MammoLink are using the KATELYN-ERIN trial to explore a broader vision for breast health, one in which imaging, molecular diagnostics and community-based access are interwoven rather than experienced as separate steps in a patient’s journey.
About Mammogen
Mammogen is a predictive health company developing RNA-powered molecular diagnostics designed to detect real-time biological signals of disease earlier and with greater accessibility across the landscape of women’s health, starting with breast cancer. The company’s lead product, genTRU-breast™, is a blood-based assay being developed to provide a real-time biologic signal that could complement imaging and support breast cancer detection, particularly in women with dense breast tissue. Mammogen’s platform is built on scalable RNA biomarker discovery and computational interpretation, with a pipeline designed to expand into additional women’s health applications over time.
About IV BioHoldings (IVBH)
IV BioHoldings (IVBH) is a technology-driven science innovation lab built to industrialize biology, turning blood-based molecular signals into scalable early detection. IVBH applies advanced computation to biomarker discovery and launches and supports operating companies that translate platform discoveries into real-world clinical products across multiple disease areas. Active programs include lung health, metabolic health and women’s health, with a defined roadmap for expansion into new verticals.
About MammoLink
MammoLink is a physician-owned breast imaging company founded by fellowship-trained breast imaging radiologist Dr. Ryan Polselli. Through a statewide network of mobile 3D mammography units and expanding fixed-site services, MammoLink brings screening mammography, diagnostic mammography and breast ultrasound closer to the women and communities it serves. Its care model combines advanced imaging, fellowship-trained interpretation and same-day results, with a focus on reducing delays and helping patients move quickly through the breast care process.
Media Contact – Mammogen
Jessica Starman
mammogen@elev8newmedia.com
888-461-2233
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