2020-08-27| R&DTrials & Approvals

FDA Okays Foundation Medicine’s Comprehensive Liquid Biopsy Test

by Rajaneesh K. Gopinath
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On August 26th, Foundation Medicine, Inc. (F.M.I) announced the USFDA approval of its comprehensive pan-tumor liquid biopsy test, FoundationOne®Liquid CDx, which will be commercially available from as early as August 28th.

By Rajaneesh K. Gopinath, Ph.D.

The use of circulating cell-free DNA (cfDNA) in the blood has become an important option to detect key mutations and learn more about certain cancers due to its less invasive nature and better reproducibility as opposed to tissue biopsies. Furthermore, the use of liquid biopsy offers an edge when there is a limitation in tissue sample volume or when the tumor location is inaccessible.

Just weeks ago, the FDA approved Guardant360 CDx assay, the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology. Along the same lines, the agency has now approved F.M.I’s FoundationOne®Liquid CDx which covers all solid tumors that are qualified under Medicare and are eligible as per the Centers for Medicare and Medicaid Services National Coverage Decision Memo criteria.

“Liquid biopsies are becoming an increasingly important option to inform personalized treatment decisions for physicians treating certain advanced cancer patients who require minimally invasive solutions to genomic testing,” said Mark Socinski, M.D., Executive Director (Thoracic Cancer) and Medical Oncologist at the AdventHealth Cancer Institute, Orlando, Florida.

“This approval helps expand access to important genomic information needed for physicians to make more informed decisions about targeted treatment approaches for their patients and is another important step toward making comprehensive genomic testing a part of routine clinical cancer care.”


The Test

FoundationOne®Liquid CDx is a qualitative NGS-based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology to analyze over 300 genes utilizing cfDNA isolated from cancer patients. It is said to demonstrate high sensitivity and specificity, even at the low allele frequencies as evaluated by multiple analytical and clinical tests. The approval is an outcome of such rigorous validations encompassing over 7,500 samples and 30,000 unique variants across over 30 cancer types. The test is now FDA-approved to report short variants in 311 genes.

FoundationOne®Liquid CDx

As determined by a global, metastatic lung cancer trial, FoundationOne®Liquid CDx is the only liquid biopsy test with the capability to identify patients harboring ALK fusions at comparable frequencies to that of solid tumor tests. It provides mutation profiles of guideline-recommended genes, including the microsatellite instability-high (MSI-H) biomarker status, and aids in informed therapy decisions. Besides, it also establishes the predictive role of tumor mutational burden (T.M.B.) biomarker to optimize precision medicine approaches.

“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.” he added.

Multiple Uses

FoundationOne®Liquid CDx acts as:

Companion Diagnostic

  • To identify patients who may benefit from treatment with specific FDA-approved targeted therapies such as PARP or tyrosine kinase inhibitors

Tumor Type

Biomarker(s) Detected


Non-small cell lung cancer (NSCLC)

EGFR Exon 19 deletions and
EGFR Exon 21 L858R substitution

IRESSA® (gefitinib)

TAGRISSO® (osimertinib)

TARCEVA® (erlotinib)

Metastatic castration-resistant prostate cancer (mCRPC)

BRCA1, BRCA2 alterations

RUBRACA® (rucaparib)


FDA-Approved Test

  • To enable accelerated companion diagnostic development for biopharma companies developing precision therapeutics; and

Comprehensive Genomic Profiling Test

  • Emulating the success of F.M.I’s tissue test, FoundationOne®CDx, the new liquid biopsy test would report on genomic alteration results by analyzing over 300 cancer-related genes. It also would provide information on biomarker statuses such as T.M.B and MSI-H, as well as single-gene alterations, including all NTRK fusions, for patients with solid tumors.

“From a clinical perspective, I believe physicians should discuss tumor genomic profiling with every metastatic prostate cancer patient to inform the use of targeted and immunotherapies,” said Neeraj Agarwal, M.D., Director of the Genitourinary Oncology Program and Professor of Medicine at the Huntsman Cancer Institute, Salt Lake City, Utah. “This approval addresses the need for blood-based genomic testing options when tissue can be challenging to obtain.”


Future Goals

F.M.I’s comprehensive genomic profiling test, FoundationOne®CDx, has garnered numerous FDA approvals as a companion diagnostic of targeted therapies for solid tumors and is the first broad companion diagnostic approved by the agency with Medicare coverage. The company will now aim to replicate the success with FoundationOne®Liquid CDx.

Speaking exclusively to GeneOnline, Dr. Brian Alexander said it is crucial for physicians to now have the availability of both their tissue and liquid biopsy options. In the coming days, F.M.I would look forward to launching the FoundationOne®Liquid CDx more globally.

“Similar to the achievements with FoundationOne®CDx, our goal with FoundationOne®Liquid CDx is to add more companion diagnostic (indications), add more diseases, and more different kinds of therapies. We want to really increase the actionability of the liquid biopsy test” he concluded.

Related Article: Foundation Medicine Fortifies Growing Prominence in Liquid Biopsy Space by Acquiring Lexent Bio



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