Genomic Health will have exclusive rights to develop and sell its Oncotype DX Genomic Prostate Score test on Biocartis' Idylla platform.
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.
NPR reports that researchers in Italy are testing a gene drive aimed at controlling mosquito populations.
Researchers may experience the effects of the government shutdown for a while, the Los Angeles Times reports.
A new study finds that the majority of patients at a Tijuana clinic received a diagnosis after first-line genome sequencing, the San Diego Union-Tribune reports.
In Genome Biology this week: post-transcriptional modification-based stratification of glioblastoma, single-cell analysis of gene expression and methylation in human iPSCs, and more.