FDA grants emergency use authorization for TessArae H1N1 influenza A virus assay
14 January 2010
The US FDA has granted Emergency Use Authorization (EUA) to TessArae for its TessArray resequencing influenza A microarray detection panel for the detection of the 2009 H1N1 influenza A virus (TessArray RM-Flu test) for the duration of the declaration of emergency unless revoked earlier.
The declaration of emergency will expire on April 26, 2010, unless terminated earlier or renewed.
The TessArray RM-Flu test is a targeted sequencing assay and 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.
The TessArray RM-Flu test was developed using Affymetrix’ MyGeneChip Custom Array Program technology and is authorized for use by CLIA High Complexity Laboratories that have access to Affymetrix microarray instrumentation. The test is performed on throat swabs taken from patients with symptoms of respiratory infection.
TessArae is one of the companies to receive an EUA from the FDA for detection of the 2009 H1N1 Influenza A virus. One of the unique aspects of the TessArray RM-Flu assay is that it directly generates genomic sequence from multiple influenza virus genes to identify the 2009 H1N1 Influenza A virus strain in a single test.
“We are very pleased that the EUA from the FDA will give healthcare providers another emergency tool for the detection of the 2009 H1N1 influenza A virus during the current outbreak using the TessArray RM-Flu test,” said Klaus Schäfer, MD, MPH, president and CEO of TessArae.
“Today’s authorization demonstrates the power of our technology to detect a novel pathogen using the appropriate targets. 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.”
GeneChip technology, through the MyGeneChip Custom Array Program, enables researchers to perform large-scale resequencing with uniform sequence coverage, long read lengths to minimize curation and assembly time, high accuracy and reproducibility, and efficient data management, while reducing the overall cost per base.
“The authorization of the RM-Flu test builds on the success of our MyGeneChip Custom Program, including GeneChip Resequencing Arrays for researchers and labs such as Harvard Partners and GeneDx,” said Kevin King, president and CEO of Affymetrix. ”This is the first microarray-based authorized test for this virus utilizing MyGeneChip Custom Array technology.”
Affymetrix technology has been used twice in products cleared by the FDA for use in in vitro diagnostics. In July 2008, the FDA cleared the Pathwork Tissue of Origin Test from Pathwork Diagnostics, Inc., for use in determining the origin of uncertain tumors.
In January 2005, the FDA cleared the AmpliChip CYP450 for diagnostic use in the United States. This was the first microarray-based diagnostic test for detection of genetic variations that can influence drug efficacy and adverse drug reactions.