Mammogen Names National Cancer Screening Leader, Dr. Rebecca Kaltman, to Lead Pivotal genTRU-breast™ Study
Executive Director of the Inova Saville Cancer Screening and Prevention Center will lead KATELYN-ERIN, Mammogen’s large prospective study evaluating its blood-based RNA assay to support breast cancer detection
NEWPORT BEACH, Calif., Oct. 20, 2026 -- Mammogen, a predictive health company, today announced that Rebecca D. Kaltman, M.D., Executive Director of the Inova Saville Cancer Screening and Prevention Center, will serve as Principal Investigator for Mammogen’s KATELYN-ERIN trial, a large prospective, multicenter study evaluating genTRU-breast™, the company’s blood-based RNA assay being developed to support earlier breast cancer detection.
KATELYN-ERIN will evaluate genTRU-breast performance within the real-world breast care pathway, comparing blood-based RNA results with biopsy-confirmed pathology. The study will also examine performance across clinically important groups, including women with dense breast tissue, where density can make cancers more difficult to detect on mammography. This clinical research program is supported by Mammogen’s Series A financing of up to $30 million, announced in June 2026.
Dr. Kaltman brings 20 years of experience spanning medical oncology, cancer prevention, clinical research, and next-generation cancer screening. She is the inaugural Executive Director of the Inova Saville Cancer Screening and Prevention Center, where she has helped advance earlier cancer detection and expand access to screening. Her experience includes participation in major blood-based cancer screening research efforts, including GRAIL’s PATHFINDER 2 study, and she serves as Principal Investigator at Inova for the NCI-supported Vanguard Study, part of the Cancer Screening Research Network. She also holds leadership roles with the American Society of Clinical Oncology and the Cancer Action Coalition of Virginia.
“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,” said Dr. Kaltman. “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.”
Inova Schar Cancer, a part of Inova Health System, will serve as a participating site for KATELYN-ERIN, with additional sites expected to open through the fall of 2026.
“Dr. Kaltman understands that the next evolution of breast cancer detection is not about replacing imaging. It is about generating the evidence needed to understand how biological information from blood can complement imaging,” said Elizabeth Cormier-May, Chief Executive Officer of Mammogen. “Her leadership in cancer prevention and next-generation screening, combined with Inova Schar Cancer’s clinical reach makes her uniquely suited to lead this rigorous prospective study and help translate its findings toward clinical practice.”
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. As the company prepared to begin the trial, Katy’s parents were asked to choose a name they felt would best honor her. They chose KATELYN-ERIN, carrying forward Katy’s story and the mission she helped inspire.
Patient enrollment for the KATELYN-ERIN trial is expected to open at Inova Fairfax later this year. Study eligibility, enrollment procedures, and additional information will be available at ClinicalTrials.gov.
Mammogen was founded within the broader IV BioHoldings (IVBH) ecosystem, an innovation platform focused on advancing scalable early detection technologies across multiple disease areas.
About the genTRU-breast Pivotal Clinical Study
The KATELYN-ERIN Trial is a prospective, multicenter clinical study designed to evaluate the performance of genTRU-breast™, Mammogen’s blood-based RNA assay being developed to support breast cancer detection. The study will enroll approximately 2,600 women who are scheduled for image-guided biopsy. Participants will provide a blood sample before biopsy, and researchers will compare the genTRU-breast RNA result with biopsy-confirmed pathology. The study is designed to evaluate the assay’s sensitivity and specificity for invasive breast cancer and to characterize performance across clinically relevant groups, including breast density, method of detection, and DCIS and benign findings. The investigational test will not replace biopsy or change participants’ medical care.
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 candidate, 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.
Media Contact - Mammogen
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