TessArae, LLC, a privately held company, and Affymetrix Inc.,
(NASDAQ:AFFX) today announced that the Food and Drug Administration
(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.
“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.”