- Cancer diagnostics firm Foundation Medicine is expanding its suite of blood-based gene sequencing tools, announcing Monday the commercial launch of its new liquid biopsy test for solid tumors.
- The assay covers 70 oncogenes as well as the biomarker for microsatellite instability, which has become newly relevant following approval of Merck & Co.'s immunotherapy Keytruda in any tumor type harboring the genetic trait.
- Now wholly owned by Swiss pharma Roche, Foundation has built its business upon rising demand for advanced genomic profiling, which is needed to match patients with the immunotherapies and targeted therapies currently reshaping cancer treatment. Liquid biopsies are the next frontier in that push.
FoundationOne Liquid, as the test is called, expands on Foundation's previous liquid biopsy test and arrives ahead of an experimental version that the company is advancing toward potential approval by the Food and Drug Administration.
Like FoundationACT, which came to market in 2016, Foundation's newly launched assay can pick up genetic alterations from DNA fragments shed by tumors into the blood. From two tubes of blood, the company says the liquid biopsy is able to pinpoint whether a tumor's growth is driven by known oncogenes like BRCA, KRAS, MET and TP53.
In a notable expansion, FoundationOne Liquid also includes several homologous recombination deficiency genes — which refer to a process used by cells to repair breaks in the twisting double strands of DNA. Changes in these genes are especially relevant to inform treatment with a class of drugs called PARP inhibitors, which induce the death of cancer cells by blocking a DNA repair mechanism.
The test has been available to select physicians since early September, but Foundation chose to officially debut it during the World Conference on Lung Cancer in Toronto.
Physicians can order the test, which costs $5,800, for their patients through Foundation. Results are usually available within two weeks, the company said.
While liquid biopsies have garnered growing interest from both oncologists and drugmakers, tissue-based tests are still the standard choice for most patients. But, in some cases, an accurate blood-based test can be preferable.
"Today, we think the best place for liquid biopsy falls into three areas," explained Tom Civik, chief commercial officer at Foundation Medicine, pointing to patients with inaccessible tumors, individuals who are too sick to undergo a tissue biopsy and those with insufficient tumor tissue to sample.
Accuracy is more difficult with liquid biopsies, as detecting circulating tumor DNA in the blood requires highly sensitive detection capabilities. Foundation says its laboratory and computational processes enable FoundationOne Liquid to deliver sensitivity between 90% and 100% when mutant allele frequency is above 0.5%.
Foundation isn't alone in its push to develop more expansive and accurate liquid biopsies. Guardant Health, a main rival, markets a blood-based test covering a similar 73 cancer genes, while others like Qiagen are developing assays as well.
A key piece of Foundation's strategy is developing its tests — both tissue and liquid — as companion diagnostics to drugs made by pharmaceutical companies. Guardant also partners with drugmakers.
To that end, Foundation is advancing another version of its liquid biopsy, for which it aims to apply for FDA approval. The regulator granted the experimental assay Breakthrough Device Designation in April.
"[FDA approval] offers us the opportunity to also add significant number of companion diagnostics to the claims we're able to make for the test," Civik said.
The third generation liquid biopsy would also cover blood tumor-mutation burden, a biomarker Bristol-Myers Squibb is relying on to make up for lost ground with its immunotherapy Opdivo (nivolumab) in non-small cell lung cancer.
Foundation hopes to be the first company with an FDA-approved liquid biopsy covering bTMB.