SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Freenome, the AI genomics company seeking to empower everyone with the tools they need to detect, treat, and ultimately prevent their diseases, announced two major milestones on its path toward a commercially available screening test – the commencement of its first clinical validation study and the hiring of Mike Nolan, previously of Foundation Medicine, as its Chief Commercial Officer.
Freenome’s AI-EMERGE Study, part of its AI-PATTERNS series of clinical studies, marks the first time an artificial intelligence (AI)-based cancer screening study is being conducted in a fully intended-use population, with patients ages 50-84, at average risk for colorectal cancer. AI-EMERGE represents an important step on the course to FDA approval.
“Doing this study in the intended use population is the most rigorous and responsible way to assess the accuracy of the test in a true screening population. In this way, we’re addressing many of the clinical and commercial limitations associated with other designs, such as retrospective or even prospective case-control studies,” said Girish Putcha, MD, PhD, Chief Medical Officer of Freenome. “Our study was specifically designed in preparation for a pre-market approval study with the FDA, a necessity for securing broadscale coverage and reimbursement from the nation’s payors.”
AI-EMERGE is being conducted in partnership with Health Decisions, the contract research organization that managed DeeP-C, the FDA premarket-approval study conducted by Exact Sciences for its stool-based colorectal screening test. The study aims to collect samples from up to 3,000 patients at sites throughout the US and Canada.
Bringing the first AI-genomics blood test for CRC to market for patients and healthcare providers will fall to clinical diagnostics veteran, Mike Nolan, Freenome’s new Chief Commercial Officer. Mike oversees global commercial and strategic partnerships, leads reimbursement strategy, and is building a commercial team that can scale and engage effectively with primary care and specialist physicians.
Most recently, Mike was Senior Vice President of Commercial Operations at Foundation Medicine, where he helped expand the use of next-generation sequencing technologies in cancer. He brings more than 25 years of global experience in the strategic management and commercial leadership of teams at companies such as Thermo Fisher Scientific, Life Technologies, Luminex, and Roche Diagnostics.
“Mike has a proven track record of building and leading teams that consistently deliver results. He has also demonstrated throughout his career the unique skill of bringing new and transformative healthcare solutions to market,” according to Gabe Otte, CEO of Freenome.
Mike joins Lena Cheng, MD, VP of Marketing, formerly of leading digital health company Doctor On Demand, where she oversaw enterprise marketing efforts for self-insured employers, health plans, and health systems. Lena also has extensive experience in healthcare advertising and direct-to-physician marketing from past roles as co-lead of the West Coast office of AgencyRx (now DDB Health), and as a key leader of the medical marketing team at Nektar Therapeutics.
About Freenome’s AI-PATTERNS Oncology Studies:
By using AI to recognize disease-associated patterns among billions of circulating, cell-free biomarkers, Freenome is developing simple, accurate, and noninvasive blood tests for early-cancer screening and treatment selection. Freenome’s AI-PATTERNS Studies are a series of rigorous clinical development and validation studies across a diverse range of cancer types. The first in the series, AI-EMERGE, is focused on colorectal cancer.
For additional details about AI-EMERGE, email clinicalstudy@freenome.com.
For more information about Freenome, visit www.freenome.com.
About Health Decisions: The Leading Full-Service Diagnostics CRO
Health Decisions is a full-service Clinical Research Organization (CRO) specializing in the clinical development of drugs, diagnostics, and medical devices in Women’s Health and related areas. Over its 29-year history, Health Decisions has conducted clinical diagnostic studies in oncology, infectious disease and obstetrics and gynecology among many others, achieving several PMA approvals and 510(k) clearances. The company is headquartered in Research Triangle Park, N.C. For more information, visit www.healthdec.com.
