NEW YORK – Personal Genome Diagnostics said today that it has received an Investigational Device Exemption (IDE) approval from the US Food and Drug Administration for the use of its elio tissue complete assay in a Merck trial of pembrolizumab-based combination therapy.
Elio tissue complete, a 507-gene NGS test that detects all classes of gene alterations and also reads out measures of microsatellite instability and tumor mutation burden, is being used in the trial to direct patient enrollment and stratification.
PGDx performs the assay in its CAP/CLIA certified laboratory and has also developed a kit version for which it hopes to garner FDA approval for clinical use across customer laboratories. Over the last year, the company has shifted its strategy away from in-house clinical testing to serving mainly pharma customers through its own lab while preparing to launch elio tissue and plasma IVDs.
Most recently, it announced that the elio tissue complete kit had received a CE mark enabling it to be marketed in Europe and other countries that recognize the CE mark. Its complementary liquid biopsy version met the same milestone last March. Neither have yet been endorsed by the FDA for clinical use, however.
PGDx CEO Doug Ward said in a statement that the agency's decision to grant the IDE for elio tissue in its work with Merck "validates the robustness of the test and reinforces the role of diagnostic biomarkers in investigating treatment strategies for patients living with cancer."
The company previously announced it was working with Merck, saying this January that it would test patients in the enrollment portion of the company's phase II KeyImpact study, exploring pembrolizumab (Keytruda) combination strategies.
John Simmons, PGDx's VP of translational medicine, confirmed today that the new IDE is for this same frontline lung cancer trial. Having it in place means that the elio test can also provide for certain exclusion criteria in the trial, which include the presence of alterations associated with ALK, EGFR, BRAF, and ROS1 in approved targeted therapies. Prior to the exemption, patients recruited to the trial would have had to have in hand other existing test results indicating that they did not carry one of these alterations.