CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
“The FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic triple-negative breast cancer, a disease with high unmet medical need,” Sandra Horning, MD, Genentech’s chief medical officer and head of global product development, said in a statement.
The accelerated approval is based on data from the phase three IM-passion130 study, which demonstrated that Tecentriq plus nab-paclitaxel reduced the risk of disease worsening or death (PFS) by 40 percent compared with nab-paclitaxel alone (median PFS=7.4 versus 4.8 months) in PD-L1-positive patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease. Overall survival results were immature with 43 percent of events in all randomized patients, and further data will be shared with the FDA and presented at an upcoming medical meeting.
The Ventana PD-L1 (SP142) Assay, launched in 2016, is the primary diagnostic assay within the Tecentriq clinical development program and was used to enroll and stratify patients in the Tecentriq clinical trials. It was previously approved by the FDA and CE marked for use as a companion diagnostic in urothelial carcinoma and as a predictive assay in second-line non-small cell lung cancer with Tecentriq.
Advanced Biological, Mayo collaborate on test for CMV patients
Advanced Biological Laboratories, a Luxembourg-based diagnostics company, and Mayo Clinic Laboratories are working together to develop a clinical test that will detect mutations associated with antiviral resistance in human cytomegalovirus.
Based on a next-generation sequencing method, the assay sequences PCR amplicons of the specific genes UL54 and UL97 of CMV. The test is coupled with Advanced Biological Laboratories’ software called DeepChek-CMV, which is used to analyze sequencing data and provide an interpretation of potential drug resistance in cytomegalovirus.
Roche launches Navify Mutation Profiler, Navify Therapy Matcher
Roche announced the CE-IVD mark and launch of its Navify Mutation Profiler, clinical software that provides annotation, interpretation, and clinical reporting of next-generation sequencing tests. Roche launched also its Navify Therapy Matcher, an optional clinical decision support app that further aids clinicians in linking clinically actionable mutations to relevant therapy options.
Navify Mutation Profiler simplifies how labs report on their NGS tests, according to Roche.
Navify Mutation Profiler and Navify Therapy Matcher together offer a “clinical decision support solution that addresses a major workflow challenge for NGS labs, synthesizing large amounts of medical and scientific data into actionable insights,” Neil Gunn, head of Roche Sequencing Solutions, said in a statement.