Foundation Medicine Secures FDA Nod for Pan Tumor TestFoundation 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.

Omar Ford

August 28, 2020

1 Min Read
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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.

 

About the Author

Omar Ford

Omar Ford is a veteran reporter in the field of medical technology and healthcare journalism. As Editor-in-Chief of MD+DI (Medical Device and Diagnostics Industry), a leading publication in the industry, Ford has established himself as an authoritative voice and a trusted source of information.

Ford, who has a bachelor's degree in print journalism from the University of South Carolina, has dedicated his career to reporting on the latest advancements and trends in the medical device and diagnostic sector.

During his tenure at MD+DI, Ford has covered a wide range of topics, including emerging medical technologies, regulatory developments, market trends, and the rise of artificial intelligence. He has interviewed influential leaders and key opinion leaders in the field, providing readers with valuable perspectives and expert analysis.

 

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