First Comprehensive Next-gen Sequencing based Pan-Tumor Liquid Biopsy Test Approved

The U.S. Food and Drug Administration (FDA) has approved FoundationOne^® Liquid CDx, a comprehensive pan-tumor liquid biopsy test developed by Foundation Medicine. The qualitative next-generation sequencing-based in vitro diagnostic test analyzes more than 300 genes and genomic signatures.

The test works 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), 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), osimertinib (Tagrisso®, AstraZeneca) and erlotinib (Tarceva®, OSI Pharmaceuticals) for the treatment of patients with non-small cell lung cancer whose tumor has EGFR Exon 19 deletion and EGFR Exon 21 L858R substitution.

Foundation Medicine’s test also works as a comprehensive genomic profiling test that reports genomic alteration results, including genomic signatures such as blood tumor mutational burden (bTMB) and high microsatellite instability (MSI), as well as single-gene alterations, including all NTRK fusions, for patients with any solid tumor as an aid in patient care.

Insurance and Costs
The diagnostic test is commercially available in the United States with costs covered across all solid tumors for eligible Medicare and Medicare Advantage beneficiaries in accordance with the Centers for Medicare and Medicaid Services National Coverage Decision Memo criteria.

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

“We believe that cancer patients and their physicians deserve the highest quality genomic testing to make informed decisions about personalized treatment,” said Brian Alexander, M.D., M.P.H., Chief Medical Officer at Foundation Medicine.

“Created from our scientific expertise and pioneering spirit, FoundationOne Liquid CDx underscores our commitment to advance patient care across all cancer types by bringing forward multiple FDA-approved comprehensive genomic profiling options that are increasingly essential for high-quality cancer care. We are seeking additional companion diagnostic claims for FoundationOne Liquid CDx, which, if approved, would further enhance the utility of the test in clinical practice. Additionally, this test is an important tool for the acceleration of drug development and for understanding mechanisms of resistance,” Alexander added.

Data delivery
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 tumor.

For many patients, getting a tissue biopsy is not an option due to tumor 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.

Analytical and clinical validation
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 tumor 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 hybridization-based capture technology to analyze 324 genes utilizing 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 labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product.

The use of the FoundationOne®Liquid CDx 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 tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if available.

FoundationOne®Liquid CDx
Indication and Technical information [Complete Label]

Featured Image: Foundation Medicine laboratory staff.  Photo courtesy: ® 2020 Foundation Medicine. Used with permission.