Cancer diagnostics firm Foundation Medicine, a member of the Roche Group, has introduced its new liquid biopsy test for solid tumours for commercial use in the US.
The blood test, called FoundationOne Liquid, is a hybrid capture-based, sequencing in vitro diagnostic device designed to detect substitutions, insertion and deletion alterations (indels), copy number alterations (CNAs) and select gene rearrangements.
The device uses a blood sample to analyse 70 genes, including homologous recombination deficiency (HRD), that increase the growth of cancer and then reports the genomic biomarker for microsatellite instability (MSI).
This analysis will assist in notifying about the use of checkpoint inhibitor immunotherapies and multiple targeted therapies such as poly (ADP-ribose) polymerase (PARP) inhibitors, as well as clinical trials for patients with advanced cancer.
Foundation Medicine chief commercial officer Tom Civik said: “With the commercial launch of FoundationOne Liquid, we are further expanding access to important genomic information that has the potential to match more patients to targeted therapies.
“For many cancer patients, traditional tissue testing is not feasible, and there is a pressing need for minimally invasive solutions to help inform personalized treatment decisions.
“FoundationOne Liquid meets our highest standards for sensitivity and analytical validation and offers providers additional insights to help guide treatment options, including immunotherapies and PARP inhibitors.
“In addition to the clinical advancements this test provides, it will also help our biopharma partners improve trial design and accelerate drug development.”
The company has evaluated the device using multiple validation methods across several tumour types and it demonstrated high sensitivity and positive predictive value.
According to the company, the device is also suitable for prior tissue-based testing methods and is claimed to offer results with longitudinal comparisons.