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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Mar 31, 2011


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.

The Scan

Single-Cell Sequencing Points to Embryo Mosaicism

Mosaicism may affect preimplantation genetic tests for aneuploidy, a single-cell sequencing-based analysis of almost three dozen embryos in PLOS Genetics finds.

Rett Syndrome Mouse Model Study Points to RNA Editing Possibilities

Investigators targeted MECP2 in mutant mouse models of Rett syndrome, showing in PNAS that they could restore its expression and dial down symptoms.

Investigators Find Shared, Distinct Genetic Contributors to Childhood Hodgkin Lymphoma

An association study in JAMA Network Open uncovers risk variants within and beyond the human leukocyte antigen locus.

Transcriptomic, Epigenetic Study Appears to Explain Anti-Viral Effects of TB Vaccine

Researchers report in Science Advances on an interferon signature and long-term shifts in monocyte cell DNA methylation in Bacille Calmette-Guérin-vaccinated infant samples.