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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Jan 13, 2011


Nanosphere said this week that it has received 510(k) clearance from the US Food and Drug Administration for its Verigene Respiratory Virus Plus nucleic acid test on the Verigene system.

The RV+ test detects influenza A, influenza B, respiratory syncytial virus A, and RSV B in a single test; and further subtypes influenza A as H1, H3, or 2009 H1N1.

The test automates the steps of viral RNA extraction, multiplexed PCR amplification, and target detection on the Verigene system, and requires only a single pipetting step, the company said. The company also noted that RV+ was operationally similar to Nanosphere's existing respiratory assay that was cleared on the same Verigene system and received a CLIA categorization of moderate complexity.

The Scan

Dropped Charges

The US Justice Department has dropped visa fraud charges against five Chinese researchers, according to the Wall Street Journal.

More Kids

The Associated Press says Moderna is expanding its SARS-CoV-2 vaccine study to included additional children and may include even younger children.

PNAS Papers on Rat Clues to Human Migration, Thyroid Cancer, PolyG-DS

In PNAS this week: ancient rat genome analysis gives hints to human migrations, WDR77 gene mutations in thyroid cancer, and more.

Purnell Choppin Dies

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