Roche said today that its cytomegalovirus viral load test is now commercially available in Europe.
CMV viral load testing helps physicians manage immunocompromised patients at risk of CMV disease, including those who have undergone solid organ and stem cell transplantation, Roche said.
Roche's test is designed for use on its fully automated Cobas AmpliPrep/TaqMan system, which combines the Cobas AmpliPrep instrument for automated sample preparation and the Cobas TaqMan analyzer or the smaller Cobas TaqMan 48 Analyzer for automated real-time PCR amplification and detection.
BD Diagnostics said this week that the US Food and Drug Administration has granted 510(k) clearance for the BD ProbeTec herpes simplex viruses Qx amplified DNA assays.
BD said that its assays are the first automated molecular tests for detecting and differentiating herpes simplex virus types 1 and 2 in clinician-collected external anogenital specimens.
The assays run on the BD Viper platform with XTR technology, which uses strand displacement amplification technology to qualitatively detect and differentiate HSV1 and HSV2 DNA.
The assays are not cleared by FDA for use with cerebrospinal fluid or lesions other than anogenital lesions; and are not for use for prenatal screening or for individuals under the age of 17 years, the company said.