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Foundation Medicine Secures FDA Nod for Pan Tumor Test

The liquid biopsy specialist said its test was based on analytical and clinical validation studies that included more than 7,500 samples and 30,000 unique variants across over 30 cancer types.

Foundation Medicine added another chapter to the liquid biopsy story after it won approval for a Pan-Tumor test with multiple companion diagnostic indications.

The Cambridge, MA-based company made the Foundation Liquid CDx available on Friday and said the diagnostic is covered across all solid tumors for eligible Medicare and Medicare Advantage beneficiaries.

FDA’s approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies that included more than 7,500 samples and 30,000 unique variants across over 30 cancer types. Evaluation of the platform using multiple validation methods across a broad range of tumor types demonstrated high sensitivity 1 and specificity, 2 even at the low allele frequencies often observed in clinical blood samples.

The test analyzes more than 300 cancer-related genes for alterations.

“We believe that cancer patients and their physicians deserve the highest quality genomic testing to make informed decisions about personalized treatment,” said Brian Alexander, M.D., M.P.H., Chief Medical Officer at Foundation Medicine. “Created from our scientific expertise and pioneering spirit, FoundationOne Liquid CDx underscores our commitment to advance patient care across all cancer types by bringing forward multiple FDA-approved comprehensive genomic profiling options that are increasingly essential for high-quality cancer care. We are seeking additional companion diagnostic claims for FoundationOne Liquid CDx, which, if approved, would further enhance the utility of the test in clinical practice. Additionally, this test is an important tool for the acceleration of drug development and for understanding mechanisms of resistance.”

This is the second significant approval in the field of biopsy in August. Earlier this month, Guardant Health won a nod from FDA for a liquid biopsy solution for comprehensive tumor mutation profiling across all solid cancers.

The Guardant360 CDx’s approval was based on clinical and analytical validation data from more than 5,000 samples.

 

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