Foundation Medicine's tumor test scores yet another companion diagnostic nod, for Genentech's Rozlytrek

Foundation Medicine’s flagship cancer diagnostic is designed to detect substitutions and alterations in more than 300 genes—and the company seemingly won’t rest until the test has been cleared for use alongside just as many cancer drugs.

The FoundationOne CDx test has already racked up more than two dozen companion diagnostic approvals from the FDA, and the list just got longer. Foundation announced Thursday that it received yet another agency from the nod, allowing the test to be used alongside Rozlytrek, a drug developed by Foundation’s fellow Roche subsidiary Genentech.

The approval makes Foundation’s test the first companion diagnostic cleared for use with Rozlytrek, the brand name for the drug entrectinib.

The FoundationOne CDx test assesses tissue samples to spot mutations in any of 324 genes and gene arrangements. It’s able to analyze all solid tumors and can complete the analysis within about 12 days from when Foundation receives the sample.

In its new use alongside Rozlytrek, it’ll specifically look for signs of ROS1-positive non-small cell lung cancer or NTRK fusion-positive solid tumors. Rozlytrek was cleared to treat patients with either of those indications in August 2019.

ROS1 gene fusions occur in 1% to 2% of non-small cell lung cancer diagnoses—which make up the vast majority of all lung cancer cases—and cause cancer cells to grow and spread uncontrollably. NTRK fusions, meanwhile, are very rare but are associated with a wide range of solid tumor types including in breast, colorectal, pancreatic and several other cancers.

“Comprehensive and validated genomic testing is critical to identify patients with ROS1 or NTRK gene fusions as they are rare and can be missed when more limited or unvalidated testing panels are used to profile a patient’s tumor,” said Mia Levy, M.D., Ph.D., Foundation’s chief medical officer. “We’re proud that this companion diagnostic will enable broader access to genomic testing and this breakthrough therapy, ultimately allowing more patients to benefit from precision medicine.”

In handing down its latest companion diagnostic approval, the FDA also tasked Foundation with conducting a post-approval study confirming the FoundationOne CDx test’s ability to spot patients with ROS1-positive non-small cell lung cancer who may respond well to Rozlytrek. Foundation said it’ll complete that research using a database of more than 100,000 genomic profiles that it has constructed in partnership with Flatiron Health.

The Rozlytrek companion diagnostic nod isn’t the test’s first foray into either indication. FoundationOne CDx has already been approved to be used alongside Bayer’s Vitrakvi for NTRK fusions and a handful of drugs targeting a variety of biomarkers for non-small cell lung cancer—though none specifically looking for ROS1 gene fusions.

Beyond those, the test has also been approved to match patients to drugs for melanoma and cholangiocarcinoma as well as breast, colorectal, ovarian and prostate cancers.