The agency has been gathering stakeholder input on how to regulate sequencing-based infectious disease diagnostics, including targeted and metagenomic approaches.
The agency cleared a broad array of in vitro diagnostic tests, including assays for influenza, whooping cough, sexually transmitted infections, and opioids.
An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.
The companies initially expect to incorporate a CDx for Incyte's pemigatinib into Foundation Medicine's existing FDA-approved assay, FoundationOne CDx.
The university health system said that it reduced incorrectly prescribed antiviral prescriptions by almost 11 percent at the sites where it installed the Roche Cobas Liat PCR test platform.
The researchers are testing the method in a clinical trial of hospital-acquired pneumonia and are working on tests for meningitis and prosthetic joint infections.
The system relies on the use of scannable safety code cards containing patient data, along with a web portal and automated analysis tools that deliver customized diagnostic reports.
The Clinical Treatment Score post-5-years tool helps clinicians identify which patients are at high risk of their cancers recurring after completing five years of adjuvant hormone therapy.
Of the 1,194 Horizon 2020 proposals received between 2014 and 2017, most were related to the development of IVDs, while a third were focused on personalized medicine.
