A: OncoCyte is a molecular diagnostics company whose mission is to provide actionable answers to physicians and patients at critical decision points across the cancer care continuum, with the goal of accelerating and optimizing diagnosis and treatment and improving patient outcomes.

We have very clear and stringent criteria for where we will participate. These are a) a high unmet medical need, b) high degree of scientific evidence, c) significant opportunity to improve patient outcomes and d), reduce overall healthcare costs.

We chose to first focus on lung cancer because despite all the advancements in screening and new treatments like immunotherapy, lung cancer continues to be the number one cancer killer in the U.S.

A: We are developing a comprehensive suite of proprietary, high value molecular diagnostics. The two diagnostics we currently have in development, DetermaVuDx and the treatment stratification test we recently acquired from Razor Genomics, are our first two initiatives aimed at providing answers at critically underserved decision points.

Our treatment stratification test identifies which patients with early stage lung cancer are at high risk for recurrence and could benefit most from chemotherapy. Despite having “curavtive surgery,” 30-50% of patients with early stage lung cancer die within five years. This test has the potential to change that reality. High-risk patients identified by the test and treated with chemotherapy post resection had a 92% disease free survival rate, compared to a 49% disease free survival rate in high-risk untreated patients.

Our goal is to deliver results to physicians and patients right when they need it, before they are required to make major decisions about their treatment. The results from this test will be made available to the treating medical oncologist, in time for a patient’s first post surgery appointment with their doctor to discuss a treatment plan.

DetermaVuDx is a liquid biopsy in development that can help physicians distinguish between benign and malignant lung nodules, thereby allowing patients to avoid risky, unnecessary lung biopsies. This test also addresses a major unmet need. Of the more than 1.6 million suspicious lung nodules detected annually via screening or incidentally, 3 out of 4 are are found to benign. A recent JAMA publication reported that 1 in 5 patients undergoing invasive diagnostic procedures experience complications, including serious complications such as bleeding and lung puncture (pneumothorax).

A: Our recent acquisition of the Razor treatment stratification test transitions OncoCyte into a commercial-stage company that is actively providing solutions to patients and physicians, a milestone of which we are exceptionally proud. We are looking forward to making the test widely available in the first half of 2020.

The Centers for Medicare Services (CMS), which covers nearly 70% of the patients who are eligible for this test, has proposed coverage for this test. We are very pleased with CMS’ decision to make this important test accessible to patients.

The Razor acquisition is just the beginning, as we are aiming to develop a comprehensive suite of tests that will position OncoCyte as a “go-to” solution when patients and physicians need answers to critical questions across the cancer care continuum. Stay tuned to the OncoCyte story as we continue making steps in this direction.

A: Most molecular tests today detect alterations at the DNA level. It is now well established that this approach has insufficient sensitivity for early-stage cancers. There is just not enough ‘signal’ to detect early stage cancers.

We are taking a different approach.

The treatment stratification test examines gene expression changes in early stage lung cancer and incorporates an extensively validated algorithm- published in some of the most respected peer-reviewed journals including, The Lancet, JAMA and JTO, to deliver actionable results to the physician.

DetermaVuDx leverages the exquisite sensitivity of the immune system’s response to early-stage cancer to measure gene expression changes in the blood that are indicative of the presence, or absence, of cancer. We are conducting perhaps the most extensive studies in this space across 64 sites in the U.S. to validate this test.

A: Significant issues exist in the current lung cancer diagnosis and treatment paradigm, chief among which is the fact that lung cancer survival rates have not increased in 50+ years, demonstrating a severe unmet need in the space. Additionally, methods of diagnosis (lung biopsies) are risky. Finally, lung cancer is uniquely complex – due to the lung’s vasculature, lung cancer is an incredibly metastatic disease. We desperately need solutions that help us diagnose lung cancer earlier and get these patients the correct treatment more efficiently.

While our current focus is lung cancer, we do believe our molecular diagnostics may be applicable in other cancer types, and we’re looking forward to continuing to explore this possibility.

A: We’re looking forward to making our treatment stratification test commercially available in 2020 and are also excited to share additional data from our CLIA validation study of DetermaVuDx in the coming months. We’re also actively engaged in continuing to advance our goal of developing a comprehensive suite of tests that can addresss significant decision points across the lung cancer care continuum.

With our strong leadership team, we believe we are well positioned to achieve these goals and make significant contributions in the lives of patients by developing tests that reduce the pain and anxiety associated with the diagnostic and treatment process.