FDA Grants Emergency Use of Flu Tests,
DNA Sequencing Technologies and Databases
The Food and Drug Administration (FDA) has granted Emergency Use
Authorization (EUA) to a Flu assay that utilizes both DNA sequencing
technologies and large public DNA sequence databases.
The TessArray® Resequencing Influenza A Microarray Detection
Panel will be used 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.
“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.”
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 a 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.
Reference Source: businesswire.com
December 22, 2009
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