- Surgery alone does not cure 30-50% of patients with early-stage lung cancer; a better means of assessing recurrence risk is needed.
- The DetermaRx test has been validated in over 1600 patients to provide this enhanced risk discrimination and identify patients who are most likely to benefit from chemotherapy.
- DetermaRx is covered by Medicare and has experienced rapid clinical adoption in recent months with availability at 47 U.S. community and academic medical centers, and international availability in Israel, India, the Middle East and Africa.
- Clinical trials like ADAURA are ushering in additional adjuvant therapy options for early-stage non-small cell lung cancer, and Oncocyte plans to offer EGFR testing paired with DetermaRx from a single sample.
2020 has ushered in two important milestones in early-stage lung cancer.
First, CMS approved DetermaRxTM a molecular test that identifies patients with Stage I-IIA non-squamous NSCLC who are at high-risk of recurrence, and may benefit from adjuvant chemotherapy.
In this webinar, we reviewed these latest research findings as well as ongoing clinical trials on the use of chemotherapy, targeted therapy, and immunotherapy in early-stage NSCLC.
The webinar also showcased new data and real world usage of DetermaRx, Oncocyte’s treatment stratification test that identifies patients with early-stage lung cancer at high-risk for recurrence post-surgical resection and may benefit from adjuvant chemotherapy. DetermaRx is the only predictive molecular test for the management of early-stage lung cancer.
About our speakers:
Dr. David Gandara is a world-renowned medical oncologist who is the Director of the Thoracic Oncology Program and Senior Advisor to the Director of the UC Davis Comprehensive Cancer Center. A recognized thought leader in lung cancer molecular diagnostics, Dr. Gandara has over 100 peer-reviewed publications including influential papers in NEJM, JAMA, and Nature. His research interests focus on developmental therapeutics of new anti-cancer agents as well as preclinical modeling and clinical research in lung cancer. He is the principal investigator on an Early Therapeutics award from the National Cancer Institute (NCI), where he leads an interdisciplinary team of clinical oncologists, pharmacologists, molecular biologists and statisticians in developing new anti-cancer agents in a variety of novel drug classes. He also leads a multispecialty team in the Southwest Oncology Group (SWOG), an NCI-funded national clinical research organization, in studies related to improving therapies for lung cancer and developing predictive biomarkers of therapeutic efficacy. Dr. Gandara received his M.D. from the University of Texas at Galveston and his B.A. from the University of Texas at Austin.
Dr. Johannes Kratz is the Director of Minimally Invasive and Robotic Thoracic Surgery and Van Auken Endowed Chair in Thoracic Oncology at the University of California, San Francisco (UCSF). Dr. Kratz played a pivotal role in the development of the DetermaRx test during his time working with David M. Jablons, M.D. and Michael Mann, M.D. as a research fellow in the Thoracic Oncology Lab at UCSF, and is now a Principal Investigator researching the genetic and immunological mechanisms that drive early-stage lung cancer. His work has been published in leading medical journals including the Lancet, JAMA, and the Journal of Thoracic Oncology. Dr. Kratz has been the recipient of numerous awards and honors including the Partners Healthcare Resident/Fellow as Teacher Award, Willard M. Daggett Award, Edward Churchill Surgical Research Fellowship, Wyeth Scholarship of the American College of Surgeons, John E. Thayer Scholarship Award, Howard Hughes Medical Fellows Program Continued Support Award, Howard Hughes Medical Student Research Fellowship, and designation as a Soma Weiss Scholar. He graduated magna cum laude from Harvard Medical School and holds a Masters in Philosophy from Stanford.
Oncocyte Forward Looking Statements
Oncocyte cautions you that this press release contains forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to the commercial launch of DetermaRx, development of DetermaIO, unexpected expenditures or assumed liabilities or other unanticipated difficulties resulting from acquisitions, implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future opportunities for Oncocyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on our financial and operational results, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of our third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to our supply chain, the need and ability to obtain future capital, maintenance of intellectual property rights, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests we commercialize, and risks inherent in acquisitions such as failure to realize anticipated benefits, unexpected expenditures or assumed liabilities, unanticipated difficulties in conforming business practices including accounting policies, procedures and internal controls, greater than estimated allocations of resources to develop and commercialize technologies, or failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
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