The U.S. Food and Drug Administration (FDA) has approved FoundationOne Liquid CDx, a blood test that can be used to identify cancer patients who may benefit from certain targeted therapies, including the FDA-approved prostate cancer therapy Rubraca (rucaparib).
The test became commercially available on Aug. 28, and is covered by Medicare and Medicare Advantage for qualifying individuals across all solid tumors.
“We believe that cancer patients and their physicians deserve the highest quality genomic testing to make informed decisions about personalized treatment,” Brian Alexander, MD, chief medical officer at Foundation Medicine, which developed the test, said in a press release.
Understanding the genetic profile of a tumor can provide useful data about prognoses, as well as indicate what treatments may or may not be appropriate. For instance, Rubraca is specifically approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC) that harbors mutations in BRCA genes. Traditional genetic analyses have typically required a biopsy of the tumor tissue itself, which isn’t always feasible.
An alternative to tumor biopsies are liquid biopsies, such as FoundationOne Liquid CDx. The overarching concept is to identify cancer cells and circulating DNA in blood, and use these cells for analyses. Since the test is done on a blood sample, only a blood draw is needed, which is less invasive than a tumor biopsy.
“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, MD, a medical oncologist at the AdventHealth Cancer Institute.
“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,” he added.
The approval also addresses the need for blood-based genomic testing options when tissue is challenging to obtain, said Neeraj Agarwal, MD, a professor at the University of Utah’s Huntsman Cancer Institute.
“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,” he said.
The blood test can also be used as a companion diagnostic for three FDA-approved targeted therapies that treat non-small cell lung cancer.
“All patients should have access to high-quality genomic insights about what is driving their tumor to help inform personalized treatment planning,” said Andrea Ferris, president and CEO of LUNGevity Foundation. “Blood-based biomarker testing options can help to expand access to these actionable genomic insights in patients with advanced cancer.”
Beyond delivering information about the suitability of targeted therapies, FoundationOne Liquid CDx also provides other genetic information about the tumor, including data about more than 300 genes of interest, as well as the overall tumor mutational burden.
The FDA’s approval was based on studies that included more than 7,500 samples of at least 30 cancer types. Using a range of validation methods, researchers found the test showed high sensitivity and specificity in identifying relevant genetic features.
“We are seeking additional companion diagnostic claims for FoundationOne Liquid CDx, which, if approved, would further enhance utility of the test in clinical practice,” Alexander said. “Additionally, this test is an important tool for the acceleration of drug development and for understanding mechanisms of resistance.”