NEW YORK (GenomeWeb) – Molecular diagnostics firms Foundation Medicine and Guardant Health both announced today that they are partnering with Mirati Therapeutics to use their assays to select lung cancer patients for a Phase 2 clinical trial of Mirati's investigational drug glesatinib. The collaborations also pave the way for development of the technologies as companion diagnostics to the drug.
The two assays — Guardant Health's ctDNA sequencing test Guardant360, and Foundation Medicine's tumor-tissue sequencing assay Foundation One — are each being used to identify non-small cell lung cancer patients with genomic alterations in the MET pathway that have been shown in prior clinical research to confer a higher likelihood of response to glesatinib.
Foundation Medicine said in its statement that its agreement with Mirati reflects a "coordinated regulatory strategy" that is expected to facilitate a submission to the U.S. Food and Drug Administration of a premarket approval for Foundation One as a companion diagnostic to glesatinib. This PMA submission would be made concurrently with Mirati's new drug application for the drug, Foundation Medicine added.
"In collaboration with Foundation Medicine, we expect to develop a companion diagnostic based upon their comprehensive genomic profiling assay that will detect all the relevant mutations in a single assay from a single biopsy, and provide patients with data to make the best treatment decisions," said Mirati CEO Charles Baum in a statement.
In its own announcement, Guardant Health said that its parallel collaboration with Mirati in the new Phase 2 trial could also result in a regulatory submission and approval of the Guardant360 test as a companion diagnostic.
Guardant Health co-founder and CEO Helmy Eltoukhy said in a statement that Guardant360 is "particularly useful for cancers driven by evolved mutations like MET amplifications."
According to Baum, identifying patients with MET mutations or gene amplification is key to Mirati's patient selection strategy. "Collaborating with Guardant on a ctDNA assay means that we expect to be able to detect these mutations in a blood sample. This will enable the more than 30 percent of non-small cell lung cancer patients, who have insufficient tumor tissue for biopsy, to be screened for genetic alterations that may be driving their cancer and to seek treatment that could lead to improved outcomes," he added.