Oncocyte said it has completed Clinical Laboratory Improvements Amendments (CLIA) validation for its DetermaIO. The Irvine, CA-based company said the diagnostic, which was previously known as the Insight Genetics IM Score Test, is used in lung cancer patients to identify individuals more or less likely to respond to anti-PD-1/PD-LI immunotherapy.

Oncocyte said the DetermaIO test differentiates itself from the current leading immunotherapy diagnostic tests by having the capability to determine if the immune microenvironment is active (“hot”) or quiescent (“cold”).

The firm said data presented at the Society for Immunotherapy of Cancer (SITC) in 2019, suggested DetermaIO may be superior to two currently marketed predictive companion diagnostic tests for immunotherapy selection, PD-L1 IHC staining (22c3, Dako) and tumor mutational burden (TMB).

Oncocyte CEO Ron Andrews said in a release, “the promising solid performance characteristics of DetermaIO will allow us to simultaneously pursue a CE mark Kit strategy in Europe where we can access the installed base of the leading PCR platform manufacturers. This type of test democratization is essential for pharma to ensure patients around the world have access to the testing that will qualify them for the most appropriate course of a particular therapy. I continue to be enthusiastic about our organizational velocity as we advance multiple product efforts simultaneously.”

Oncocyte inherited the test from Insight Genetics. It announced it was acquiring Insight in January and closed on the deal in February. In September of 2019, the company was involved in another acquisition. The firm picked up Brisbane, CA-based Razor Genomics, which has a test that enables the identification of lung cancer patients at high risk for recurrence and allows them to be treated at a time when their cancer can still be responsive to adjuvant chemotherapy.