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Oncocyte Announces New Prospective Data Demonstrating That Treatment Informed by DetermaRx™ Significantly Improves Lung Cancer Patient Survival

Data to be Presented by Dr. Gavitt Woodard of Yale University at the IASLC 2020 North America Conference on Lung Cancer Results and Clinical Utility to be Discussed During KOL Webinar on October 22nd at 11:00 am PT

· 10/14/2020 08:04

Data to be Presented by Dr. Gavitt Woodard of Yale University at the IASLC 2020 North America Conference on Lung Cancer

Results and Clinical Utility to be Discussed During KOL Webinar on October 22nd at 11:00 am PT featuring Dr. Woodard and Dr. David Gandara of UC Davis

IRVINE, Calif., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Oncocyte Corporation (NYSE:OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced that new prospective data on DetermaRx™ will be presented at the IASLC 2020 North America Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer. These data will be presented by Gavitt Woodard, M.D., Assistant Professor, Yale School of Medicine, and lead author on the study. DetermaRx is a treatment stratification test that identifies stage I-IIA non-small cell lung cancer (NSCLC) patients at high-risk of recurrence despite ostensibly curative surgery, who may benefit from the addition of chemotherapy. The test is reimbursed by Medicare and has seen rapid adoption in its first year of launch across seventy hospitals, including National Comprehensive Cancer Network (NCCN) and National Cancer Institute (NCI) cancer centers.

Presentation highlights from the prospective study of 250 consecutive stage I-IIA non-squamous NSCLC patients that received the DetermaRx test include:

  • High-risk status as identified by the DetermaRx test was used to inform the use of adjuvant chemotherapy, and strikingly, 94% of patients who selected adjuvant chemotherapy were cancer-free after five years of follow-up. In contrast, one in three high-risk patients who elected to forego chemotherapy had a recurrence.
  • No DetermaRx-identified low-risk patients were treated with chemotherapy, and only 5% of them reported a cancer recurrence, suggesting that this test may also inform the choice to avoid potentially unnecessary but toxic chemotherapy.
  • These data expand and reinforce the strong survival benefit previously demonstrated in the first 100 patient study previously published.
  • EGFR status was not prognostic when data was evaluated in a cohort of 150 patients
  • DetermaRx identified high-risk patients who responded to adjuvant chemotherapy, independent of EGFR status
  • Data presented at the annual ASCO meeting from the ADUARA trial, reported improved survival rates in surgically resected NSCLC patients with an EGFR mutation treated with the targeted therapy osimertinib (Tagrisso®) These results inform the usage of the targeted therapy osimertinib in conjunction with chemotherapy, in EGFR positive patients.

“We are very pleased that the initial data showing this test’s impact on cancer recurrence was maintained in the 250-patient expanded data set. This result establishes DetermaRx as the post-surgical treatment standard for patients diagnosed with NSCLC,” said Dr. Edgardo S. Santos, M.D., Florida Precision Oncology, a Division of Genesis Care and an early adopter of the test. “The integration of testing for targeted therapy, including EGFR mutation status and chemotherapy selection by DetermaRx on the same sample, will enable oncologists to optimize and sequence treatment post-surgery. In my opinion, these two tests together close the few remaining gaps that we currently face in deciding adjuvant therapy for early-stage adenocarcinoma of the lung. With these results, I would feel confident initiating chemotherapy, followed by targeted therapy for the EGFR-positive, DetermaRx high-risk patients I see in my practice.”

Key takeaways include:

  • Combining DetermaRx risk status with EGFR mutation status may help inform optimal treatment strategies for non-small cell lung cancer (NSCLC) patients who are EGFR-mutation-positive.
  • DetermaRx may inform the usage of chemotherapy, in addition to osimertinib, in the approximately 33% of EGFR positive patients who DetermaRx also identified as high-risk for cancer recurrence.
  • Given these data, Oncocyte will be offering EGFR mutation testing and DetermaRx on the same sample starting this quarter.

Padma Sundar, Senior Vice President, Commercial at Oncocyte, commented, “Coming off a very strong third quarter (during which we received final Medicare pricing within our expected range, and saw DetermaRx order volumes more than double from the second quarter), we are extremely excited about the release of the new prospective data. We believe these data expand the utility of DetermaRx for both chemotherapy and targeted therapy selection, ultimately facilitating continued rapid market adoption. As DetermaRx is the only validated test for guiding standard of care adjuvant chemotherapy post-surgery, we will continue to add other actionable markers to our testing as more therapy options become available for these patients. The addition of EGFR testing for osimertinib is an exciting first step in that direction.”

Results from the study will be discussed at a KOL webinar on October 22nd at 11:00 am PT led by Gavitt Woodard, M.D., Assistant Professor, Yale School of Medicine, cardiothoracic surgeon and lead author on the study, and David Gandara, M.D., Professor of Medicine Emeritus at the University of California, Davis, and Director of Thoracic Oncology at the UC Davis Comprehensive Cancer Center (UCDCCC).

For more details on the webinar and to register, please click here