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FDA Approves First Comprehensive Pan-Tumour Liquid Biopsy Test for Patients with Advanced Cancer

A qualitative next generation sequencing based in vitro diagnostic test analyzes more than 300 genes and genomic signatures
03 Sep 2020
Personalised medicine

On 26 August 2020, the Foundation Medicine, Inc. announced that the US Food and Drug Administration (FDA) approved FoundationOne®Liquid CDx, the comprehensive pan-tumour liquid biopsy test. It acts as:

  • a companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies, including an indication for rucaparib (Rubraca, Clovis Oncology, Inc), a poly (ADP-ribose) polymerase inhibitor for treatment in patients with BRCA1/2-mutant metastatic castration-resistant prostate cancer, and three first-line tyrosine kinase inhibitors gefitinib (Iressa, AstraZeneca AB Corporation), osimertinib (Tagrisso, AstraZeneca AB Corporation) and erlotinib (Tarceva, OSI Pharmaceuticals, LLC) for the treatment of patients with non-small cell lung cancer whose tumour have EGFR Exon 19 deletion and EGFR Exon 21 L858R substitution;
  • an FDA-approved test to enable accelerated companion diagnostic development for biopharma companies developing precision therapeutics; and
  • a comprehensive genomic profiling test that reports genomic alteration results, including genomic signatures such as blood tumour mutational burden (bTMB) and high microsatellite instability (MSI), as well as single gene alterations, including all NTRK fusions, for patients with any solid tumour as an aid in patient care.

It is commercially available from 28 August 2020 and is covered across all solid tumours for eligible Medicare and Medicare Advantage beneficiaries in accordance with the Centers for Medicare and Medicaid Services National Coverage Decision Memo criteria.

The company is seeking additional companion diagnostic claims for FoundationOne Liquid CDx, which, if approved, would further enhance utility of the test in clinical practice.

FoundationOne Liquid CDx results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies and, within its professional services section, delivers information about the genomic signatures MSI and bTMB, as well as single gene alterations, including all NTRK fusions, to help inform the use of other therapies including immunotherapies. The report also provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumour.

For many patients, getting a tissue biopsy is not an option due to tumour location or the patient’s health status, or a patient may simply prefer not to have an additional procedure. Blood-based biomarker testing options can help to expand access to these actionable genomic insights in patients with advanced cancer.

The FDA’s approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies that included more than 7,500 samples and 30,000 unique variants across over 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.

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridisation-based capture technology to analyze 324 genes utilising circulating cell-free DNA isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients.

The test is FDA-approved to report short variants in 311 genes, including rearrangements and copy number losses in BRCA1 and BRCA2, and is a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies in accordance with the approved therapeutic product labelling. Additional genomic findings may be reported and are not prescriptive or conclusive for labelled use of any specific therapeutic product.

Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumour tissue testing and mutation status confirmed using an FDA-approved tumour tissue test, if available.

The complete label, including companion diagnostic indications and complete risk information is available here.

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