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FDA Approves Foundation Medicine Blood Test as CDx for Rozlytrek

NEW YORK – Foundation Medicine said Wednesday its FoundationOne Liquid CDx test has received approval from the US Food and Drug Administration as a companion diagnostic for Genentech's Rozlytrek (entrectinib).

Foundation Medicine and Genentech are both subsidiaries of Roche.

Oncologists will be able to use FoundationOne Liquid CDx, a blood-based liquid biopsy test, to identify patients with ROS1-positive non-small cell lung cancer and patients with NTRK fusion-positive solid tumors who don't have a tissue sample available to see if they are appropriate for treatment with Rozlytrek, a targeted therapy that treats those cancer mutations.

The test, which is a next-generation sequencing-based in vitro diagnostic test, analyzes more than 300 cancer-related genes based on a patient's blood sample. It's already approved as a companion diagnostic for nine targeted therapies, including Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).

FoundationOne Liquid CDx is the only blood-based companion diagnostic approved for Rozlytrek, the firm said.

"Liquid biopsies can make molecular testing possible for patients when tissue is not available," said Mia Levy, chief medical officer at Foundation Medicine, in a statement.

The FDA approval follows the approval of Foundation Medicine's tissue-based comprehensive genomic profiling test, FoundationOne CDx, as a companion diagnostic for Rozlytrek in July.

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