Diagnostics developer Mammogen has named Dr. Rebecca Kaltman to lead its prospective KATELYN-ERIN trial evaluating the blood-based RNA assay genTRU-breast. The multicenter study will enroll approximately 2,600 women scheduled for image-guided biopsies, comparing molecular test results against biopsy pathology to improve detection, particularly for patients with dense breast tissue.
Dr. Rebecca Kaltman to Lead KATELYN-ERIN Trial at Inova Schar Cancer
Mammogen selected Dr. Rebecca Kaltman, Executive Director of the Inova Saville Cancer Screening and Prevention Center, to serve as principal investigator for the KATELYN-ERIN study. Bringing 20 years of experience spanning medical oncology, cancer prevention, clinical research, and next-generation cancer screening, Dr. Kaltman additionally contributes her expertise through leadership positions with the Cancer Action Coalition of Virginia and the American Society of Clinical Oncology.
The study evaluates genTRU-breast, Mammogen’s blood-based RNA assay designed to support earlier breast cancer detection by capturing real-time biological signals. The clinical program builds on Mammogen’s Series A financing of up to $30 million announced in June 2026.
Detecting breast cancer earlier and with greater precision has been the focus of my career, which is what makes the potential of genTRU-breast so compelling. Women with dense breast tissue represent one of the most underserved populations in cancer screening today. This trial will help us determine whether a blood-based RNA signal can provide meaningful biologic information alongside imaging and ultimately help give women and their physicians clearer answers earlier.
Dr. Rebecca Kaltman, Executive Director of the Inova Saville Cancer Screening and Prevention Center
Study Design and Patient Enrollment Across 2,600 Scheduled Biopsies
The multicenter trial is designed to enroll approximately 2,600 women scheduled for image-guided biopsies. Participants provide blood samples prior to their biopsy procedures, allowing researchers to evaluate genTRU-breast performance against biopsy-confirmed pathology. The investigation will evaluate performance across clinically important groups, including women with dense breast tissue.
Operating as a participating site for KATELYN-ERIN, Inova Schar Cancer is part of Inova Health System, while further locations are anticipated to launch through the fall of 2026.
MammoLink Partnership Expands Trial Reach Through Mobile 3D Mammography
To broaden community access, Mammogen established a clinical research alliance with MammoLink, a specialized women’s health imaging provider established by breast imaging radiologist Dr. Ryan Polselli. The collaboration integrates MammoLink’s mobile network of six 3D mammography units across Florida into the trial infrastructure.
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.
Dr. Ryan Polselli, Founder of MammoLink
Honoring Katy Shea Butts and the Mission Behind Mammogen
The KATELYN-ERIN trial derives its name from Katy Shea Butts, whose breast cancer diagnosis at 29 years old helped inspire Mammogen’s founding mission centered on creating blood-based technologies for earlier cancer detection.
Operating as part of the IV BioHoldings (IVBH) ecosystem, Mammogen emerged from this broader innovation platform dedicated to advancing scalable early detection technologies spanning various disease areas.