At his FDA Law Blog, Jeffrey Gibbs discusses FDA's technical assistance for the draft Diagnostic Accuracy and Innovation Act.
The company highlighted growth in demand for its test , and is now ramping up marketing and focusing on its IVD development plans.
Revenues for Roche Diagnostics totaled CHF 6.26 billion for H1, driven primarily by demand for immunodiagnostic solutions.
Clinicians are using Roche's Cobas Omni Utility Channel to run lab-developed PCR tests alongside in vitro diagnostic kits, freeing valuable resources for labs.
The agency finalized recommendations for developing and validating NGS tests, and proposed a submission process for investigational IVDs in cancer Rx trials.
The hospital will run Agendia's new NGS test kit in its lab, comparing results with the firm's existing centralized MammaPrint test.
The company discussed expectations for how its products will fare against rivals into next year based on recent data and coverage decisions, and on expected reimbursement changes.
Companies are now expected to have their tests cleared by authorities for clinical use, and to bring their entire catalogs into line with the new regulations by May 2022.
Genomic Health will gain exclusive worldwide rights to develop and sell an IVD version of its Oncotype DX breast cancer test on Biocartis' Idylla platform.
The test is intended to detect FLT3 mutations in order to select patients for treatment with Novartis' Rydapt, and has also been approved by the US FDA.
In a statement, National Institutes of Health Director Francis Collins says sexual harassment is "morally indefensible" and "unacceptable."
Octopuses might owe their intelligence to their liberal alterations to their genes, Cosmos reports.
Stat News and ProPublica report that African Americans are underrepresented in cancer clinical trials.
In Cell this week: genomic analysis of abdominal aortic aneurysm, effect of probiotics on the microbiome, and more.