The Cologuard colorectal cancer screening test is the first product to make it through a new pilot program that offers parallel review of medical devices and diagnostics by both the Food and Drug Administration and the Centers for Medicare & Medicaid Services.
Biodesix recently announced the inclusion of its VeriStrat profiling test in updated evidence-based, consensus-driven NCCN Guidelines for managing non-small-cell lung cancer.
The Lab 7 Enterprise Sequencing Platform is a software solution that enables deep data provenance while streamlining routine operations for next-generation sequencing labs.
Under an FDA emergency use authorization, BioFire’s commercial BioThreat-E test for the ebola Zaire virus is now available to high- and moderate-complexity clinical laboratories in the United States.
ARK Diagnostics and Roche have announced a partnership to integrate ARK’s methotrexate test into the Roche therapeutic drug monitoring menu for its Cobas C 501 and Cobas C 502 clinical chemistry analyzers.
After a positive evaluation by Palmetto GBA, CMS has approved coverage of the molecular diagnostic to predict risk of recurrence and drug therapy benefit in breast cancer patients.
Diagnostic applications of liquid biopsy as precision medicine technology in cancer and organ transplantation explored at Digital PCR Conference.
One of the largest insurance companies in the United States, Highmark has announced it will begin providing coverage of the VeriStrat assay to guide second-line treatment decisions for patients with non-small cell lung cancer. Coverage takes effect on October 27, 2014.
CMS has agreed to provide reimbursement coverage for Exact Sciences’ first-mover FDA-approved noninvasive stool DNA screening test for colorectal cancer.
A new multiyear, multi-investigator research collaboration will accelerate the translation of genomic discoveries into clinical diagnostics in oncology.