OncoCyte Corporation, a developer of novel tests for the early diagnosis and management of lung cancer, today announced the successful completion of the CLIA Validation study of DetermaDx (previously DetermaVu), its liquid biopsy test in development to aid in ruling-out malignancy in lung nodules and potentially avoiding unnecessary invasive lung biopsies. With the completion of CLIA Validation, the Company will commence Clinical Validation, which, if successful, will establish the independent clinical performance of the test prior to commercial launch. Once Clinical Validation is completed and performance parameters are established, OncoCyte will begin preparations for commercial availability, including publication of the Clinical Validation results needed for CMS reimbursement dossier submission as well as the execution of additional clinical utility studies.
“We are encouraged by the completion of the CLIA Validation study, which demonstrates the successful transfer of the research assay to the rigorous environment of our commercial CLIA laboratory, including demonstration of excellent reproducibility,” said Lyndal Hesterberg, Ph.D., Chief Scientific Officer of OncoCyte. “Every year more than 1.6 million lung nodules are detected on imaging, but a majority of these nodules are found to be benign following an invasive diagnostic procedure such as a tissue biopsy, which can be associated with serious complications. DetermaDx has the potential to reduce the number of unnecessary procedures by identifying patients with likely benign nodules who could be routed to surveillance instead of an invasive diagnostic procedure.”
Dr. Hesterberg continued, “With lung cancer being the leading cause of cancer death, primarily due to late diagnosis, we believe DetermaDx has the potential to significantly change the paradigm for early stage lung cancer patients. This is a significant step towards making DetermaDx available to physicians and patients looking for actionable information that may be helpful for managing either incidental lung nodules or those detected by screening. We’re looking forward to continuing to advance DetermaDx, along with DetermaRx (previously the Razor treatment stratification test) for chemotherapy benefit prediction in early stage patients, to enable the diagnosis and treatment of lung cancer at its earliest stages when it is more treatable, thereby improving patient survival rates for this deadliest cancer.”
DetermaDx is a multigene assay that measures gene expression in circulating blood cells and, in conjunction with certain clinical factors, may help rule out cancer in patients with lung nodules identified by CT scans. The completion of the CLIA Validation study confirms the reproducibility, accuracy and precision of the gene measurements and the combined multivariate assay. OncoCyte tested approximately 120 samples previously used in its R&D development study and successfully reproduced the results in the Company’s CLIA laboratory.
DetermaDx is OncoCyte’s liquid biopsy test currently in development which has the potential to identify lung nodules that are likely benign, enabling patients to avoid potentially risky invasive biopsy procedures. The test utilizes a proprietary immune system interrogation approach and algorithm to integrate the results from RNA sequencing and clinical factors to deliver actionable findings to physicians, identifying a nodule as “likely benign” or “suspicious”. OncoCyte estimates that a $1.8 billion annual market could develop in the U.S. for DetermaDx, depending on market penetration and reimbursable pricing.
Source – Globe Newswire