Foundation Medicine, Inc. today announced that FoundationOne®Liquid, its next-generation liquid biopsy test for solid tumors, is commercially available in the United States. Using a blood sample, FoundationOne Liquid analyzes 70 genes known to drive cancer growth, including homologous recombination deficiency (HRD) genes, and reports the genomic biomarker for microsatellite instability (MSI),1 to help inform the use of checkpoint inhibitor immunotherapies and multiple targeted therapies, including poly (ADP-ribose) polymerase (PARP) inhibitors, as well as clinical trials for patients with advanced cancer.
“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,” said Tom Civik, Chief Commercial Officer at Foundation Medicine. “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.”
FoundationOne Liquid is a hybrid capture-based, next-generation sequencing in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations (indels), copy number alterations (CNAs) and select gene rearrangements using circulating cell-free DNA (cfDNA) isolated from plasma derived from peripheral whole blood. The FoundationOne Liquid test expands upon the previous version of the Company’s liquid biopsy test, FoundationACT®, which has been analytically validated across the four main classes of genomic alterations. Evaluation of the platform using multiple validation methods across a broad range of tumor types demonstrated high sensitivity2 and positive predictive value3, even at the low allele frequencies often observed in clinical samples.4
“This is an important new option for metastatic cancer patients with insufficient tumor tissue specimens or for those at risk for invasive biopsy,” said Tianhong (Tina) Li, MD, PhD, University of California Davis Comprehensive Cancer Center. “FoundationOne Liquid expands the ability of clinicians to select the most appropriate cancer therapy based on individual patients’ molecular and immune biomarker profile at initial diagnosis and as the disease progresses.”
FoundationOne Liquid represents the latest advance in Foundation Medicine’s long-standing commitment to develop innovative liquid biopsy technologies. In April 2018, the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation for the Company’s liquid biopsy assay currently in development that includes the genomic biomarker blood tumor mutational burden (bTMB). If approved, this forthcoming test could be the first FDA-approved liquid biopsy test to incorporate multiple companion diagnostics (CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.
FoundationOne Liquid can also be used to complement prior tissue-based testing methods, providing results with longitudinal comparisons to previous Foundation Medicine test results. Foundation Medicine offers an option to automatically reflex to FoundationOne Liquid if tissue is insufficient for tissue-based testing.
Source – Foundation Medicine
- MSI status will be reported for samples determined to have high microsatellite instability.
- >99% sensitivity for base substitutions, indels and rearrangements at >0.5% mutant allele frequency (MAF). Sensitivity for copy number variations is >95% when the tumor fraction is ≥20%. Internal data on file.
- >99% PPV for all alterations, calculated as a weighted average of the PPV for each class of alteration, with the weighting based upon the frequency with which FoundationACT detects each class of alteration. The PPV for copy number variations at ≥20% tumor fraction is 97.6%. Internal data on file.
- Clark et al. Analytical validation of a hybrid capture-based next-generation sequencing clinical assay for genomic profiling of cell-free circulating tumor DNA. The Journal of Molecular Diagnostics. 2018. doi: https://doi.org/10.1016/j.jmoldx.2018.05.004