CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
When Congress passed the 21st Century Cures Act in 2016, it included language aimed at improving the update process, but the groups say they are concerned there hasn’t been a significant increase in the FDA Center for Drug Evaluation and Research’s acceptance of current, updated breakpoints.
Thermo Fisher, AstraZeneca to develop companion diagnostic for Tagrisso
Thermo Fisher Scientific is working with AstraZeneca to develop a solid tissue and blood-based companion diagnostic test for Tagrisso (osimertinib).
The test will help identify patients with non-small cell lung cancer who may be eligible for treatment with Tagrisso by identifying tumors that exhibit EGFR alterations including exon 21 L858R mutations, exon 19 deletions, or T790M mutations. Thermo Fisher says the collaboration will leverage the Oncomine Dx Express Test on the Genexus Dx System.
Digital pathology codes
The CAP has made available online information related to the 13 category III digital pathology codes that became effective Jan. 1. Each code and its descriptor is provided, along with answers to multiple frequently asked questions, among them: Do the codes have reimbursement rates attached? Do they have both TC and -26 components? Visit https://capatholo.gy/3HcLy2u.