Roche gets US FDA approval for 'FoundationOne Liquid CDx' test

Roche announced on Friday that the US Food and Drug Administration (FDA) has approved ‘FoundationOne Liquid CDx’, a comprehensive pan-tumour liquid biopsy test for patients with solid tumours from its Foundation Medicine division.

The Swiss drugmaker described FoundationOne Liquid CDx as a “comprehensive genomic profiling” (CGP) test that analyses more than 300 cancer-related genes and multiple genomic signatures, to optimise patient care.

It explained that cancer is a disease of the genome, driven by genetic mutations within a tumour’s DNA.

CGP is used to identify those unique mutations to determine how a tumour behaves and grows, with those insights helping physicians to determine a personalised treatment plan for each individual patient, based on the specific mutations identified.

As well as approving FoundationOne Liquid CDx as a CGP test for patients with any solid tumour, the FDA approved the test for use as a companion diagnostic to identify patients who could benefit from treatment with certain prostate and lung cancer therapies, including ‘Rubraca’, or rucaparib, a poly-polymerase (PARP) inhibitor for treatment in patients with BRCA 1/2-mutant metastatic castration-resistant prostate cancer, and three first-line tyrosine kinase (TKI) inhibitors for the treatment of patients with non-small cell lung cancer.

By incorporating multiple genes, including several companion diagnostic biomarkers, the test could help save time when compared to sequential biomarker testing.

“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.

“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.”

Roche said FoundationOne Liquid CDx 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.

The test is FDA-approved to report short variants in 311 genes, including rearrangements and copy number losses in BRCA1 and BRCA2 genes.

It said the results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies.

The report also delivers information about genomic signatures, including microsatellite instability and blood tumour mutational burden, as well as single gene alterations, including all NTRK fusions, to help inform the use of other therapies including immunotherapies, and provides relevant clinical trial information.

The FDA approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies including more than 7,500 samples and 30,000 unique variants across more than 30 cancer types.

Evaluation of the platform using multiple validation methods across a broad range of tumour types demonstrated high sensitivity and specificity, even at the low allele frequencies often observed in clinical blood samples.