Skip to main content
Premium Trial:

Request an Annual Quote

Gen-Probe Seeks FDA Approval for Donor Blood HBV Assay

NEW YORK (GenomeWeb News) – Gen-Probe has filed for clearance with the US Food and Drug Administration for additional use of the Procleix Ultrio assay to screen for hepatitis B virus in donated blood, the company said today.
The company seeks FDA approval that would allow it to administer the assay on its semi-automated platform and on its fully automated, high-throughput TIGRIS system.
Between 2006 and 2007, the FDA cleared the Procleix Ultrio to screen for HIV-1 and HCV in donated blood, plasma, organs, and tissue on both of its instrument systems. However, those clearances did not cover screening for HBV in donated blood because the assay was not tested for HBV yield in donated blood.
The company said that after discussions with the FDA it agreed with the Novartis-owned company Chiron to conduct a post-marketing study to demonstrate the test’s HBV yield capability, and a subsequent screening of 500,000 samples yielded two cases of HBV.
Procleix and Ultrio are property of Novartis, which serves as one of Gen-Probe’s distributors.

The Scan

Just Breathing

A new analysis suggests that most Mycobacterium tuberculosis is spread by aerosols from breathing, rather than by coughing, the New York Times reports.

Just Like This One

NPR reports that the World Health Organization has hired a South African biotech company to recreate mRNA vaccine for SARS-CoV-2 that is similar to the one developed by Moderna.

Slow Start

The Wall Street Journal reports that Biogen's Alzheimer's disease treatment had revenues for July through September that totaled $300,000.

Genome Research Papers on Cancer Chromatin, Splicing in the Thymus, Circular RNAs in Cancer

In Genome Research this week: analysis of bivalent chromatin sites, RBFOX splicing factors' role in thymic epithelial cells, and more.