Foundation Medicine’s cancer-profiling blood test approved by FDA

Foundation Medicine’s cancer-profiling blood test approved by FDA

The FDA has approved Foundation Medicine’s liquid biopsy blood test, allowing oncologists to profile the genomic mutations found within any solid tumor without needing to remove and analyze small slices of tissue, and to help assign an individual cancer patient their most correct treatment.

The comprehensive FoundationOne Liquid CDx test returns reports on more than 300 alterations in cancer-related genes, as well as biomarkers such as tumor mutational burden and microsatellite instability to predict a person’s response to certain therapies.

“Many cancer patients are unable to have a tissue biopsy,” said Foundation Medicine co-founder Levi Garraway, who currently serves as chief medical officer and head of global product development at Roche, its corporate parent.

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“FoundationOne Liquid CDx may provide a minimally-invasive option for patients who otherwise might not have benefitted from comprehensive genomic profiling,” Garraway said. “The convenience of testing a blood sample may also enable more rapid treatment decisions, so that patients can feel reassured they are not losing time to fight their disease.”

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The test—which, starting today, replaces Foundation Medicine’s current liquid biopsy diagnostic, FoundationOne Liquid—sifts through the blood to find the small pieces of floating DNA released from tumors found elsewhere in the body.

Alongside its approval as a sequencing test for understanding the genetic basis of a particular cancer—based on studies of more than 7,500 samples and over 30 tumor types—the FDA also granted the test the ability to help oncologists directly prescribe four targeted cancer treatments.

RELATED: Foundation Medicine acquires liquid biopsy developer Lexent Bio

This includes three different tyrosine kinase inhibitor therapies for non-small cell lung cancers with certain EGFR mutations: AstraZeneca’s Iressa and Tagrisso, as well as Tarceva from Roche’s Genentech division. The liquid biopsy was also approved as a companion diagnostic for Clovis Oncology’s Rubraca, for metastatic, castration-resistant prostate cancer with BRCA1 and BRCA2 alterations.

“We are seeking additional companion diagnostic claims for FoundationOne Liquid CDx, which, if approved, would further enhance utility of the test in clinical practice,” said Foundation Medicine’s chief medical officer, Brian Alexander. 

“Additionally, this test is an important tool for the acceleration of drug development and for understanding mechanisms of resistance,” Alexander added, by providing complementary insights to tissue-based testing on the differences between cancer cells, as well as how tumors evolve over time.

The approval comes shortly after the FDA’s green light earlier this month for Guardant Health’s pan-tumor profiling blood test, which uses next-generation sequencing to identify mutations in 55 genes linked to multiple cancers.

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