Burning Rock Gains Japan Approval for Breast Cancer Diagnostic
The nod from regulators clears the way for the company's OncoGuide system to be used with AstraZeneca's capivasertib for certain cancer patients.
Burning Rock Biotech Limited (NASDAQ: BNR) saw its shares climb over 1.7% after announcing it had received regulatory clearance in a key international market. The company's OncoGuide™ OncoScreen™ Plus CDx System has secured from the Ministry of Health, Labour and Welfare (MHLW).
The approval designates the system as a companion diagnostic for capivasertib, a breast cancer treatment developed by AstraZeneca. The test is designed to guide treatment for patients with HR-positive, HER2-negative unresectable or recurrent breast cancer who have one or more specific gene alterations. By using a next-generation sequencer, the system can in a single test, helping clinicians identify patients who are most likely to benefit from the targeted therapy.
This regulatory win marks a significant step in Burning Rock's international expansion. The approval was achieved in collaboration with Riken Genesis Co., Ltd., which will now handle preparations for securing insurance coverage in Japan, a critical step for patient access and commercial adoption. The Japanese market represents a substantial opportunity for advanced cancer diagnostics, and this approval provides a foothold for Burning Rock's precision oncology portfolio.
In a statement, Burning Rock's CEO, Yusheng Han, described the approval as and emphasized its potential to optimize treatment plans and improve outcomes for breast cancer patients. Building on this momentum, the company is also actively pursuing product registration in China, signaling a broader push across key Asian markets.