On November 4, 2021 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer, reported the clinical launch of its DetermaIOTM test (Press release, Oncocyte, NOV 4, 2021, View Source [SID1234594571]). DetermaIO is a proprietary gene expression test that assesses the tumor immune microenvironment (TIME) to predict response to immunotherapy. In multiple clinical studies evaluating hundreds of patients across multiple tumor types, including lung, breast, bladder and renal cancers, the test has demonstrated the ability to predict response to immune checkpoint inhibitors (ICI) which has the potential to help inform the optimal use of immunotherapy treatment for more than one million eligible patients annually in the United States alone.
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"For my patients with lung cancer, there are myriad treatment options including mono immunotherapy, combination immunotherapy with chemotherapy, and even a combination of two immunotherapies, each with their benefits and risks in terms of toxicity and side effects," said Dr. Nagdala Abdel-Karim, Director of the Thoracic Oncology Multidisciplinary Clinic and Medical Director of the Georgia Cancer Centers Clinical Trials Program. "Therefore, selecting the right immunotherapy regimen for the patient is a very complex decision. We use PD-L1 and occasionally tumor mutational burden (TMB), but neither biomarker is completely accurate or takes into account both the tumor and its microenvironment, which is important as both determine response to immunotherapy. I am impressed with the DetermaIO data, especially the superior progression free survival relative to legacy biomarkers and feel confident it will enable us to better navigate the immunotherapy decision."
In studies in multiple solid tumors presented at oncology congresses around the world, including at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and American Association of Cancer Research (AACR) (Free AACR Whitepaper), and in a peer-reviewed publication with authors from MD Anderson and Yale, DetermaIO has demonstrated superior utility in identifying patients who may respond to immunotherapy compared to alternative biomarkers in development. DetermaIO has also demonstrated superior utility in identifying patients who are unlikely to benefit from these immune therapies which can cause serious, long-lasting side effects. In a study presented at the recent ESMO (Free ESMO Whitepaper) congress, triple negative breast cancer patients randomized to receive either neoadjuvant chemotherapy alone or chemotherapy combined with an immune checkpoint inhibitor, DetermaIO positive patients had a 20% higher pathologic complete response only when an ICI was added to standard of care chemotherapy (71% response compared to 51%), while those patients who were DetermaIO negative showed no additional benefit from the addition of immunotherapy to a standard of care regimen. This study confirmed findings in a previously published study where ICI given in combination with standard neoadjuvant chemotherapy showed far superior benefit in DetermaIO positive patients compared to DetermaIO negative.
Padma Sundar, Chief Commercial Officer of Oncocyte, said, "Given the data presented to date, there is strong interest among physicians to access this test and incorporate it into their practice to aid in the complex decision making for immunotherapy treatment. We are launching the test initially as part of an early access program to optimize sample processing and logistics, targeting sites that have successfully partnered with Oncocyte on prior tests. Recruitment for the early access program is ahead of schedule and clinical samples are expected to begin coming in before the end of the year. Demonstrating test adoption is an important step towards pursuing Medicare reimbursement, along with peer reviewed publications which are in progress, and we remain committed to deliver our reimbursement dossier in the first half of 2022."
Ms. Sundar continued, "The next step in our menu roll out is to combine DetermaIO with DetermaTx, a DNA/RNA based comprehensive genomic profiling test, which already has established Medicare reimbursement rates. With both tests performed on a single sample, we will deliver the most complete and differentiated biomarker information needed to make both immunotherapy and targeted therapy decisions to treating physicians, while conserving precious sample and minimizing turnaround time. This, combined with DetermaCNI, our blood-only test for treatment resistance monitoring currently in clinical trials, builds on our ‘one-lab’ offering, and will differentiate us with oncologists. Our one lab and sample sparing approach strengthens our position as an emerging leader in precision oncology testing."
The launch of DetermaIO is built on the growing body of evidence on the clinical applications of the test, suggesting a potential pan-cancer and pan-immunotherapy utility in both primary and metastatic settings. In combination with the Company’s robust pipeline of diagnostic and monitoring tools, as well as its recently-launched real world cancer registry in early stage NSCLC for DetermaRx, this launch underscores Oncocyte’s commitment to driving rigorous science in order to empower surgeons, physicians, and their patients to better manage the oncology patient journey.
About DetermaIO
DetermaIO is a 27-target multivariate gene expression test performed on FFPE biopsy specimens that measures the presence of subtypes of infiltrating inflammatory cells, and the presence or absence of a differentiated stromal microenvironment. DetermaIO’s proprietary algorithm combines mRNA gene expression data to interpret the physiology of both the tumor and its surrounding micro-environment in order to predict the response to immuno-oncology therapies. For more information, visit www.oncocyte.com/products/determa-io.