Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced the completion of the Clinical Validation study of DetermaDx™, the Company’s liquid biopsy test intended to clarify whether a lung nodule is suspicious or likely benign. Findings from the Clinical Validation study demonstrated that the performance of DetermaDx did not meet the predetermined endpoints for the study.

“DetermaDx represents Oncocyte’s legacy work on the first step of the cancer care continuum – diagnosis. Appropriate management of incidentally identified lung nodules is critical, as early diagnosis of lung cancer has a significant impact on patient survival,” said Ron Andrews, Chief Executive Officer of Oncocyte. “We had one main criteria for the launch of our test in designing our clinical validation study: statistically significant improvement over and above the clinical factors being utilized by physicians today to help with the diagnosis of intermediate risk nodules, particularly in the 0.8-2.2cm nodule size range. Unfortunately, DetermaDx did not achieve that endpoint in Clinical Validation.”

Mr. Andrews continued, “Based on the results of the Clinical Validation study, we have made the decision to cease further investment in DetermaDx and focus our efforts on maximizing the significant opportunities that we see for our two more advanced commercial tests. We have a balanced portfolio of tests in market launch phases and are enthusiastic about the Company’s progress over the last year and our future prospects.”

The Company made two important acquisitions over the last year and has commercialized two tests in 2020. DetermaRx, intended for treatment selection in early stage lung cancer management, is launched for clinical use. It is covered by Medicare, has been reimbursed by several commercial payers and is gaining traction in community-based health systems despite the challenges in the macroenvironment relating to the COVID-19 pandemic. This test has a global opportunity of more than 350,000 patients annually and a worldwide market size of over $500M.

The second test is DetermaIO for immunotherapy response prediction, with studies completed in non-small cell lung cancer and triple negative breast cancer by researchers at the West Clinic and MD Anderson Cancer Center, respectively, with results presented at SITC 2019 and the ASCO 2020 annual meetings. This test is currently available for biopharma diagnostic development and research use only and has significant potential as a companion test to select patients for clinical trials and, ultimately, as a full companion diagnostic for clinical use of immunotherapies in patient management. With close to 800,000 patients eligible to receive immunotherapies in the U.S. alone, and no robust test available that provides a clear understanding of which patients are most likely to have a sustained response to these costly therapeutics, we believe this may represent a significant opportunity for DetermaIO.

Concluding, Mr. Andrews said, “The strategic vision of being a one lab resource for physicians managing lung cancer patients remains intact despite today’s news. We look forward to continuing our current organizational velocity as we now focus on gaining commercial traction with our recently launched tests.”

Source: Company Press Release