mismatch repair deficiency
Promega to Develop Microsatellite Instability Companion Diagnostic Kit With GlaxoSmithKline
The IVD kit will be used to identify patients with the MSI biomarker who may be eligible for potential treatment with GSK's Jemperli (dostarlimab-gxly).
Biocartis Nabs FDA 510(k) Clearance for Lynch Syndrome Screening Assay
The Idylla MSI Test identifies microsatellite instability in colorectal cancer tumors to aid in the identification of potential Lynch syndrome.
Roche Nabs FDA Label Expansion for Ventana CDx Panel
The immunohistochemistry companion diagnostic helps identify patients with solid tumors that are deficient in DNA mismatch repair.
In new guidelines, an expert panel recommended IHC and PCR for certain cancer types and pointed out knowledge gaps supporting NGS in other settings.
FDA Approves GlaxoSmithKline's Jemperli, Roche’s Ventana CDx for dMMR Solid Cancers
The approval expands the label for GSK's anti-PD-1 agent dostarlimab, which the FDA initially approved in April for patients with dMMR endometrial cancers.
Jul 22, 2021