FNIH Biomarkers Consortium Launches Project that will Standardize the Measurement of Genetic Blood Tests to Track Cancer

September 24, 2019 — The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium has launched a new project under its Cancer Steering Committee that will standardize the assessment of genetic tests that use blood samples to track cancer in hospitals and laboratories across the United States. In particular, the project will develop tools to enable clinicians to measure and confidently compare circulating tumor DNA (ctDNA) test results across different laboratories.

ctDNA is genetic material released by a tumor into the blood that reveals important cancer mutations for therapies to target, making it the most widely-used biological marker (biomarker) obtained through a blood test to monitor cancer. However, the measurement of ctDNA is not standardized and the same sample can produce conflicting results when tested in multiple laboratories. “The Identification and Validation of ctDNA Quality Control Materials” project will address this challenge by developing reference materials so that clinical sites can produce universally-recognizable ctDNA measurements and confidently interpret them.

The project team includes experts from the FNIH, National Cancer Institute, National Institute of Standards and Technology, U.S. Food and Drug Administration, not-for-profit organizations, commercial control companies and the pharmaceutical industry. The team will evaluate these reference materials through validation studies at independent laboratories. Development of these standards will pave the way for more effective cancer treatment and provide a framework that can streamline development and regulatory approval of tests that evaluate genetic material in cancer patients.

For more information about the project, click here.

Public Partners:
Frederick National Laboratory for Cancer Research*
National Cancer Insitute
National Institute of Standards and Technology*
U.S. Food and Drug Administration

Private Partners:
American Society of Clinical Oncology
Association for Molecular Pathology
AstraZeneca*
College of American Pathologists
Genentech, a Member of the Roche Group*
Horizon Discovery Ltd*
Janssen*
Merck Sharpe & Dome Corp.*
Pfizer Inc*
SeraCare Life Sciences, Inc., an LGC Group Company*
Thermo Fisher Scientific*

Academic Partners:
Dana-Farber Cancer Institute
Harvard University
Mayo Clinic

*provides financial or in-kind support for this program.

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