The study will assess the feasibility of conducting a successful randomized clinical trial using multi-cancer detection screening tests.
BETHESDA, MD., June 5, 2025 –
The IVD Regulatory Consulting Team at Precision for Medicine has been selected by the National Institutes of Health (NIH), to support regulatory submissions for the National Cancer Institute’s Vanguard Study, a pivotal initiative in multi-cancer detection research.
The Vanguard Study is a four-year pilot program led by the NIH/NCI Cancer Screening Research Network (CSRN) that aims to evaluate the feasibility of implementation of blood-based multi-cancer detection (MCD) tests into future randomized controlled trials. With up to 24,000 participants, the study will provide critical insights to inform a larger-scale randomized controlled trial investigating whether MCD tests enable earlier cancer detection—when treatment is most effective.
“The Vanguard Study will assess whether MCD tests can provide a meaningful new cancer screening approach enabling life-changing treatments in the early stages of cancer." said Kennon Daniels, PhD, Vice President of IVD Regulatory Consulting at Precision for Medicine. “Precision was selected for our extensive IVD Regulatory expertise in assay regulatory strategy and submission development, having successfully authored more than 180 Q-Submissions and 50 IDE application approvals in the United States."
As part of its role, Precision for Medicine supported the Pre-Investigational Device Exemption (IDE) Q-Submission for the Vanguard Study and facilitated meeting with the U.S. Food and Drug Administration (FDA). Precision has managed the application preparation, review, and submission of all regulatory materials required for the study’s IDE application with the FDA. The IDE received approval within 30 days on April 24, 2025. The team also led communications to ensure all regulatory requirements are met, facilitating a smooth study launch.
For more information on the Vanguard Study, visit the NCI/NIH press release.
About Precision for Medicine
Precision for Medicine is the first biomarker-driven clinical research and development services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Precision for Medicine applies a transformational approach to clinical research that integrates clinical trial design and execution with deep scientific knowledge, laboratory expertise and advanced data intelligence. This convergence is driving faster clinical development and approval. Precision for Medicine is part of Precision Medicine Group, with 3,500 people in 40 locations globally across North America, Europe and Asia-Pacific. For more information, visit PrecisionForMedicine.com.
About the National Cancer Institute (NCI):
NCI leads the National Cancer Program and NIH’s efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website at cancer.gov or call NCI’s contact center, the Cancer Information Service, at 1-800-4-CANCER (1-800-422-6237).
Contact
Brad Epstein
Chief Marketing Officer
Precision for Medicine
brad.esptein@precisionformedicine.com