Tissue-Based Testing
News on immunohistochemistry and other tissue-based testing methods.
FDA Approves Roche Antibody Test as CDx for Enhertu in HER2-Ultralow Breast Cancer Patients
The tissue-based test is approved to identify a new classification in HER2 expression designated as HER2-ultralow.
The organization is leveraging its growing bank of whole-slide pathology images to create models that could form the backbone of cancer testing applications.
Abbott, BioMérieux, Cepheid, Roche, Others Gain FDA 510(k) Clearances in December
The FDA granted marketing clearances for infectious disease tests, updates to a digital pathology system, and immunoassays for chronic diseases.
Foundation Medicine Assay Nabs FDA Approval as CDx for Ojemda in Pediatric Patients
The FoundationOne test can be used to identify patients with relapsed or refractory BRAF-altered pediatric low-grade glioma who may be eligible for therapeutic options.
Paige Nabs 510(k) for Image Viewer Use With Leica, Hamamatsu Scanners
The recent clearance and a previous clearance together allow the use of Paige's FullFocus digital pathology image viewing software with scanners by Philips, Leica, and Hamamatsu.