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TessArae Gets FDA Emergency Use Authorization for H1N1 Assay

NEW YORK (GenomeWeb News) – Privately held TessArae today announced that it has received Emergency Use Authorization from the US Food and Drug Administration for its 2009 H1N1 Influenza A assay.

The firm said that the EUA for its TessArray Resequencing Influenza A Microarray Detection Panel will expire on April 26, 2010, unless terminated earlier or renewed. The targeted sequencing assay is the "first high-density, microarray-based single test intended for the in vitro qualitative detection of the 2009 H1N1 influenza A virus, aided by an algorithm that relies on seasonal A/H1N1 and seasonal A/H3N2 influenza virus results," TessArae said in a statement.

"The RM-Flu assay harnesses both DNA sequencing technologies and large public DNA sequence databases that are available today, and represents a new approach to sequencing-based diagnostics," Klaus Schäfer, president and CEO of TessArae, said in a statement.

It is the latest of several assays to receive an FDA EUA since the flu outbreak earlier this year. Among the other firms to receive EUA's for their assays are Focus Diagnostics, which is owned by clinical lab giant Quest Diagnostics, Gen-Probe's Prodesse business, clinical lab Diatherix Laboratories, Roche, and DxNA. The first assay to receive the EUA was developed by the US Centers for Disease Control and Prevention and was cleared in April.

The assay was developed through Affymetrix's MyGeneChip Custom Array Program and is authorized for use in CLIA high-complexity labs that use Affymetrix's microarray instruments.