US approves Roche's new pan-tumour liquid biopsy test

US regulators have approved Roche's new pan-tumour liquid biopsy test for patients with solid tumours, offering a potentially more convenient option and an alternative for patients unable to have tissue biopsy.

FoundationOne Liquid CDx is a genomic profiling (CGP) test that analyses more than 300 cancer-related genes and multiple genomic signatures to identify genetic mutations within a tumour and optimise patient care.

The test analyses circulating cell-free DNA from a patient’s blood sample and uses massively parallel sequencing to detect the four main classes of genomic alterations.

Regulators have also approved the test for use as a companion diagnostic to identify patients who may benefit from treatment with certain prostate and lung cancer therapies, including Rubraca (rucaparib) and three first-line tyrosine kinase (TKI) inhibitors.

“Many cancer patients are unable to have a tissue biopsy. FoundationOne Liquid CDx may provide a minimally-invasive option for patients who otherwise might not have benefitted from comprehensive genomic profiling,” said Levi Garraway, Roche’s executive vice president, chief medical officer, head of Global Product Development and co-founder of Foundation Medicine Inc.

“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.”