Test Shows How Lung Cancer Patients Respond to Therapy

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 ...
Source: MDDI - Category: Medical Devices Authors: Tags: IVD Regulatory and Compliance Source Type: news