Burning Rock Biotech (BNR) Announces Exclusive in-Licensing of Risk Stratification Test for Early Stage Lung-Cancer Patients from Oncocyte (OCX) in China

December 15, 2020 6:54 AM EST

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Burning Rock Biotech Limited (NASDAQ: BNR) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE: OCX) to bring DetermaRx™, a risk stratification test for early stage lung cancer patients, to China.

Even though early-stage non-small-cell lung cancer (NSCLC) generally demonstrates a good prognosis after surgery, a significant proportion of early-stage NSCLC patients suffer from fast relapse, which is generally attributable to metastatic disease undetected at complete resection. Management of such patients depends on prognostic staging to identify the individuals most likely to have occult disease. DetermaRx is a treatment stratification test that identifies stage I-IIA non-squamous NSCLC patients at high-risk of recurrence despite ostensibly curative surgery, who may benefit from the addition of chemotherapy. The test was originally developed at the University of California, San Francisco, in a cohort of 361 patients with non-squamous NSCLC. The assay was then independently validated in a masked cohort of 433 patients with stage I non-squamous NSCLC at Kaiser Permanente Northern California hospitals, and an independently recruited cohort of 1006 patients with stage I–III non-squamous NSCLC from multiple leading Chinese cancer centers.1 In a 250-patient prospective cohort, test-identified low-risk patients had a 5-year freedom from recurrence (FFR) rate of 94.6%; test-identified high-risk or intermediate-risk patients who were treated with adjuvant platinum chemotherapy had 96.7% 5-year FFR compared to 71.7% 5-year DFS for high-risk patients who did not receive chemotherapy. Recurrence rate in molecular high-risk stage IA patients was 25%, compared to only 3% in molecular low-risk stage IA patients. In addition, the assay is independent of EGFR mutation status, and effectively segregates high- and low-risk patients among those with both EGFR wildtype and mutant tumors. 2 The test received final Medicare LCD from Palmetto in April 2020.

“This agreement with Burning Rock accelerates the ongoing expansion of our DetermaRx test to patients and physicians outside the U.S., and exemplifies our global growth strategy,” said Ron Andrews, Chief Executive Officer and President of Oncocyte. “We believe aligning with one of the largest and fastest growing companies in China’s NGS-based cancer therapy selection market speaks to the strength of DetermaRx as a valuable treatment stratification tool to help clarify this critical treatment decision point in early stage tumors. We are honored to partner with Burning Rock, whose comprehensive portfolio of molecular tests for the oncology market allows us access to the largest eligible patient population in the world as well as China’s major cancer centers. In addition to expanding our available market, this important milestone also provides us with non-dilutive capital and an ongoing revenue stream to strengthen our growth trajectory as well as help reduce our operational cash burn.”

Yusheng Han, Founder and Chief Executive Officer of Burning Rock added, “We are excited to be entering into this agreement with Oncocyte. As the leader of NGS application in oncology in China, we are committed to providing the best diagnostic solutions to Chinese patients and oncologists. China's stage I-IIA non-squamous NSCLC incidence is estimated at over 100,000 per annum.3 We believe Oncocyte’s risk stratification test fills a clear unmet need in identifying those patients who are at high risk and may benefit from adjuvant chemotherapy, versus low risk patients who do not have to undergo unnecessary chemo treatments, in a convenient and affordable manner. Combining DetermaRx with our products for genetic testing and MRD detection (currently under R&D), we can provide a comprehensive testing strategy for oncologists to ultimately benefit Chinese early-stage NSCLC patients by improving their survival and quality of life. We look forward to expanding this much-needed and promising test to the Chinese market and continuing to collaborate with Oncocyte in the future.”

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