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Friday, August 28, 2020

FDA OKs Roche pan-tumor liquid biopsy test

The FDA approves Roche (OTCQX:RHHBY) unit Foundation Medicine’s FoundationOne Liquid CDx, a comprehensive pan-tumor liquid biopsy test for solid tumors. The genomic profiling test analyzes more than 300 cancer-related genes and multiple genomic signatures based on circulating cell-free DNA in a blood sample using massively parallel sequencing to detect the four main classes of genomic alterations.

It is also approved as a companion diagnostic for Clovis Oncology’s (NASDAQ:CLVS) PARP inhibitor Rubraca (rucaparib) for certain prostate cancer patients and three first-line tyrosine kinase inhibitors for non-small cell lung cancer.


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