Original from: Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the European Union In Vitro Diagnostic Regulation (IVDR) approval of several label expansions for the VENTANA® MMR RxDx Panel, an immunohistochemistry (IHC) companion diagnostic test that aids in identifying a cancer patient’s mismatch repair (MMR) status. MMR is a process that scans a person’s genetic code and fixes errors to prevent mutations that can lead to cancer. The test evaluates a panel of MMR proteins in tumours to provide this important treatment information to clinicians.
“By providing a standardised testing option for mismatch repair status with our VENTANA MMR RxDx Panel, we are empowering clinicians to make more informed decisions and expanding access to important therapies for patients across multiple solid tumor types,” said Laura Apitz, Head of Pathology Lab at Roche Diagnostics. “This milestone exemplifies our dedication to delivering high-medical-value solutions that help improve patient outcomes through precision medicine."
The VENTANA MMR RxDx Panel is now available in countries regulated by IVDR as a companion diagnostic for the following therapies and cancer types:
- KEYTRUDA® (pembrolizumab), Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy: For the treatment of mismatch repair deficient (dMMR) tumors in certain adults with: metastatic colorectal cancer; advanced or recurrent endometrial carcinoma; unresectable or metastatic gastric, small intestine or biliary cancer.
- IMFINZI® (durvalumab), AstraZeneca’s anti-PD-L1 therapy: For adult patients with dMMR primary advanced or recurrent endometrial cancer.
- IMFINZI® + LYNPARZA® (olaparib), AstraZeneca’s anti-PD-L1 therapy and PARP inhibitor: For adult patients with mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer.
- JEMPERLI® (dostarlimab-gxly), GSK’s anti-PD-1 therapy: for dMMR patients with endometrial cancer.1
Source: Roche’s VENTANA MMR RxDx Panel CDx receives IVDR approval across multiple cancer types and therapies
