Burning Rock Biotech Ltd. and Riken Genesis Secure Japan's Approval for OncoScreen™ Plus CDx System as Companion Diagnostic for Breast Cancer Treatment
Reuters
Sep 24
<a href="https://laohu8.com/S/BNR">Burning Rock Biotech</a> Ltd. and Riken Genesis Secure Japan's Approval for OncoScreen™ Plus CDx System as Companion Diagnostic for Breast <a href="https://laohu8.com/S/CTHZ">Cancer Treatment</a>
Burning Rock Biotech Ltd. has announced that its OncoGuide™ OncoScreen™ Plus CDx System has received Manufacturing and Marketing Approval from Japan's Ministry of Health, Labour and Welfare (MHLW) as a companion diagnostic for AstraZeneca's capivasertib in breast cancer. This approval, achieved in partnership with Riken Genesis, marks the first for a combination medical device product by the two companies. The CDx System is designed to guide treatment decisions for adult patients with unresectable or recurrent hormone-receptor $(HR)$-positive, HER2-negative breast cancer by detecting PIK3CA, AKT1, and PTEN gene alterations. The system's approval supports patient selection for capivasertib in combination with fulvestrant, aiming to improve precision diagnostics and expand therapeutic opportunities for breast cancer patients in Japan.
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