Close Menu

FDA clearance

The FDA cleared two assays with samples collected during women's routine liquid-based Pap testing for cervical cancer screening.

The ProParaflu+ assay joins a line of tests Prodesse sells for diagnosing and differentiating respiratory viruses.

The FDA cleared an update to the package insert for its Verigene Respiratory Virus Nucleic Acid Test to include reactivity with Influenza A in cultured clinical isolates containing 2009 H1N1 influenza virus.

Roche becomes the latest of a handful of vendors to get an EUA from the FDA to sell its 2009 H1N1 flu assay to CLIA labs.

The guidance document is intended to help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus, and provides information regarding filing for Emergency Use Authorization.

The FDA cleared the firm's microarray-based multiplex platform and a rheumatoid arthritis test that runs on the system.

The FDA cleared analytical reactivity information to be added to a package insert for the firm's RAMP Influenza A/B Assay.

The newest authorization allows testing on 3M's molecular diagnostic system.

Nanosphere received FDA clearance for its influenza and respiratory virus test to run on its new Verigene SP System.

Pages

GenomeWeb reports that Veritas Genetics is suspending its US operations.

A Brazilian-led team of researchers reports it has generated a sugarcane genome assembly that encompasses more than 99 percent of its genome.

Certain plasma proteins could be used to gauge a person's age and whether they are aging well, according to HealthDay News.

In Science this week: approach to measure microRNA targeting efficiency, strategy to conduct high-throughput chemical screens at single-cell resolution, and more.