TessArae Gets FDA Emergency Use Authorization for H1N1 Assay
The Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to TessArae, LLC, a privately held company headquared in Potomac Falls, for its TessArray(R) 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.
“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.
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(TM) 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.
According to Schäfer, “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.”
