Monday, January 9, 2017

Genomeweb Publishes 2016 Year in Review Article

The trade journal and information hub Genomeweb has published its annual Genomics Year in Review for CY2016 - online here [subscription].

The 2600-word article discusses the boom in immunotherapy diagnostics, including the new role for immunohistochemistry there, the freeze on the FDA's regulation of LDTs, the continued chance that IVD diagnostics will be undercut by LDTs even though there were more pharma-diagnostic joint development programs last year than ever.   The FDA is showing more flexibility in approving NGS diagnostics than ever, with more coming this year (such as oncology gene panel tests by FMI, Illumina, Thermo Fisher).   Reimbursement remains an issue, although December brought a significant expansion in covered tumor profiling by the MolDX program at Medicare.