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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Jan 14, 2010

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Seegene said this week that Health Canada has granted it a Medical Device License for its Seeplex Diarrhea-V ACE Detection test.

The company said that the multiplex assay uses proprietary PCR technology to simultaneously amplify target pathogens. The test detects a range of viral pathogens that cause diarrhea, including enteric adenovirus, Group A rotavirus, Norovirus GI/GII, and Astrovirus

The license from Health Canada is the first approval for the test in North America. It is already CE-Marked for use in Europe.


Enzo Biochem said this week that its Enzo Clinical Labs division is now providing Roche Diagnostics' H1N1 PCR test for physicians throughout the Metropolitan New York, including New Jersey and parts of Pennsylvania.

Roche gained an Emergency Use Authorization from the US Food and Drug Administration for its RealTime ready Influenza A/H1N1 Detection Set last November.

The kit detects RNA from the 2009 H1N1 influenza A virus and is used in conjunction with Roche's RealTime ready RNA Virus Master kit.

The Scan

Purnell Choppin Dies

Purnell Choppin, a virologist who led the Howard Hughes Medical Institute, has died at 91, according to the Washington Post.

Effectiveness May Decline, Data From Israel Suggests

The New York Times reports that new Israeli data suggests a decline in Pfizer-BioNTech SARS-CoV-2 vaccine effectiveness against Delta variant infection, though protection against severe disease remains high.

To See Future Risk

Slate looks into the use of polygenic risk scores in embryo screening.

PLOS Papers on Methicillin-Resistant Staphylococcus, Bone Marrow Smear Sequencing, More

In PLOS this week: genomic analysis of methicillin-resistant Staphylococcus pseudintermedius, archived bone marrow sequencing, and more.