BD Diagnostics said this week that it has filed for 510(k) clearance with the US Food and Drug Administration for its BD ProbeTec HSV-1 and HSV-2 Qx Amplified DNA assays.
The assays will run on the BD Viper system with XTR technology, which uses strand displacement amplification to qualitatively detect and differentiate herpes simplex virus I and II DNA in clinician-collected external anogenital lesion specimens.
BD said that its tests will allow laboratories to read up to 96 positive or negative results in about two and a half hours
BD said that if cleared, the assays would be the first fully automated molecular tests to diagnose and differentiate HSV types 1 and 2.
Celera this week said that it has submitted a premarket approval application to the US Food and Drug Administration for its KIF6 Genotyping Assay.
According to Celera, the assay is a molecular in vitro diagnostic designed to detect a marker for risk of coronary heart disease independent of traditional risk factors and clinical evaluation when statin treatment is being considered.
Celera is seeking regulatory approval to perform the KIF6 Genotyping Assay on Abbott's fully automated m2000 real-time PCR instrument system, of which more than 870 have been placed in laboratories worldwide.
In September, shortly after Celera received the CE IVD Mark for a real-time PCR test for KIF6 variants, it granted Abbott exclusive rights to market and distribute the test on the CE-Marked m2000 system in Europe and other areas recognizing the CE Mark (PCR Insider, 9/23/10).
Cepheid last week announced the release of its Xpert Flu test as a European CE IVD Mark product.
The test, which runs on Cepheid's GeneXpert System, simultaneously detects and differentiates Flu A, Flu B, and 2009 H1N1 influenza virus in about one hour.
Although 2009 H1N1 is no longer at pandemic levels in the US, a December 2010 report from the European Centre for Disease Prevention and Control indicated that the start of the 2010-11 European flu season is being dominated by the 2009 H1N1 virus.
Cepheid said that Xpert Flu is expected to become available in the US early this year.