ARTICLE | Regulation

Sept. 2 Quick Takes: Owkin receives EU approval for two AI-based cancer diagnostics

Plus FDA panel to discuss GSK’s anemia drug daprodustat, and updates from Neukio, Abivax and more

September 3, 2022 1:39 AM UTC

Owkin Inc. received the European Union’s CE-IVD approval for two cancer diagnostics based on AI analysis of digital pathology slides, which could scale up biomarker testing and precision treatment strategies for more patients. One of the tests, dubbed Owkin Dx RlapsRisk, predicts the risk that patients with early ER+/HER2- breast cancer will relapse, and thus may benefit from additional treatment, without requiring molecular or genetic testing. The other, Owkin Dx MSIntuit, identifies microsatellite stable (MSS) samples, allowing pathologists looking for patients with microsatellite instability (MSI) to focus their resource- and sample-consuming tests on the samples most likely to be MSI high, a biomarker for response to immunotherapy.

FDA’s Cardiovascular and Renal Drugs Advisory Committee will convene Oct. 26 to discuss the NDA for Duvroq daprodustat from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis. The PDUFA date is Feb. 1, 2023. The oral HIF-PH inhibitor is approved in Japan to treat patients with renal anemia and is under review in Europe...