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Burning Rock's System Approved in Japan as Companion Diagnostic for AstraZeneca's Capivasertib
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Burning Rock's System Approved in Japan as Companion Diagnostic for AstraZeneca's Capivasertib
Sep 24, 2025 3:48 AM

06:27 AM EDT, 09/24/2025 (MT Newswires) -- Burning Rock Biotech ( BNR ) said Wednesday its OncoGuide OncoScreen Plus CDx System based on OncoScreen Plus has received manufacturing and Marketing approval from Japan's Ministry of Health, Labour and Welfare.

The system is intended to be used as a companion diagnostic for AstraZeneca's ( AZN ) capivaertib, which is intended for breast cancer.

According to the company, the CDx System is a combination medical device consisting of the OncoGuide OncoScreen Plus CDx Kit and the OncoGuide OncoScreen Plus CDx Analysis Program.

Burning Rock's partner, Riken Genesis, will begin preparations for insurance coverage, the company said.

Burning Rock Biotech ( BNR ) shares were up more than 3% in recent premarket activity Wednesday.

Price: 9.50, Change: +0.32, Percent Change: +3.49

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