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
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
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