Oncocyte Corporation (NYSE:OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced the presentation of data on its DetermaIO™ test at the Association for Molecular Pathology (AMP) 2020 Virtual Conference being held virtually November 16-20. DetermaIO is a CLIA validated test currently available for research use in clinical trials. The test uses real-time PCR to measure expression of 27 genes and a proprietary immune-oncology (IO) algorithm with demonstrated predictive capabilities for patient response to immune checkpoint inhibitor (ICI) therapies in non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). The biology behind the test, which assesses the entire tumor microenvironment, may identify resistance mechanisms that may be overcome by second generation therapies.
These new data being presented at AMP demonstrate that the test is reproducible at tissue inputs compatible with small tissue samples, thus potentially increasing the number of patients who would qualify for testing. As little as 2mm2 of tissue, or a single slide, was required to generate reproducible results in the study. This tissue requirement is as much as ten-fold lower than required for some marketed NGS gene panel tests. For example, PD-L1 testing requires 3-5 slides while tumor mutational burden (TMB) requires as many as ten slides for testing, often times exhausting the tumor tissue available. In lung cancer, it is estimated that 15-30% of samples from biopsies have insufficient tissue for standard molecular tests. The Company believes that these data, together with an anticipated turnaround time of three to five business days for test results, could position DetermaIO as a convenient and practical choice when the test becomes available for use in routine clinical testing.
“Managing late stage cancer patients and guiding therapy decisions can be challenging due to limited tissue samples and the large amount of tissue required to run NGS testing and other molecular diagnostics,” said Doug Ross, M.D., Ph.D., Chief Medical Officer of Oncocyte. “In lung cancer, we are often limited to a fine needle aspirate, which leads to over 25% of patients not able to receive targeted panel or TMB testing. These data presented at AMP add to the growing body of evidence on the checkpoint inhibitor predictive capability of DetermaIO and importantly, as a PCR-based test, may allow its rapid adoption regardless of the quantity of tissue available. The minimal tissue requirements for successful test performance reported at AMP mean that a large number of patients could potentially qualify for testing with DetermaIO, overcoming challenges sometimes seen with targeted testing. In addition, preserving precious tissue samples may allow pathologists to also perform other important tests which could aid in a more thorough initial diagnosis and therapy decisions. We look forward to moving this work forward as we increase the adoption of DetermaIO in the research setting in pharma and academia, with an ultimate goal of making the test available in the clinical setting to provide comprehensive IO solutions to patients and physicians.”
Details on Oncocyte’s poster presentation:
Title: Tissue Requirements of a Novel 27-Gene Immuno-Oncology Algorithm Measuring Tumor Microenvironment to Predict Response to Immunotherapies
Authors: Tyler J Nielsen, Frank B McMahon, Jeremy Spille, David R Hout, Kim Dickinson, Brock L Schweitzer