Foundation Medicine, Inc. today announced that it received approval from the New York State (NYS) Clinical Laboratory Evaluation Program (CLEP) for its FoundationACT® blood-based circulating tumor DNA (ctDNA) assay. The CLEP regulates and seeks to ensure the accuracy and reliability of test results in clinical laboratories located in or accepting specimens from NYS. With the approval of FoundationACT, the company’s suite of comprehensive genomic profiling products is available to oncologists and patients in all 50 states.
The FoundationACT assay is designed to identify clinically-relevant genomic alterations driving the growth of a patient’s cancer. This liquid biopsy assay can help physicians identify treatment options by providing clinically actionable information about potential targeted therapies and/or available clinical trials from only a blood sample. FoundationACT is analytically validated to detect genomic alterations in more than 60 of the most clinically-relevant cancer genes in solid tumors.
“We believe New York state conducts one of the most rigorous assessments of laboratory developed tests in the nation, and its approval of FoundationACT speaks to the quality and reliability of our assay,” stated Jeffrey S. Ross, M.D., medical director for Foundation Medicine. “We’re delighted to begin offering FoundationACT to physicians and their patients in the State of New York, and most importantly, to advance access and improve treatment options for individuals living with cancer.”
Source – BusinessWire