SANTA CLARA, Calif. & POTOMAC FALLS, Va.--(BUSINESS WIRE)--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.
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. 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.
For more information about the TessArray Resequencing Influenza A Microarray Detection Panel for the Detection of the 2009 H1N1 Influenza A Virus and to order it, please visit: www.tessarae.com/h1n1flu.
About TessArae, LLC
TessArae, founded in 2005, is a next generation diagnostics and bioinformatics company that designs and develops microarray-based resequencing applications in the fields of infectious disease detection and identification, pharmaceutical manufacturing QA/QC, tools for genetic testing and services for research and clinical diagnostics, by leveraging the molecular genomics, infectious disease, medical, and public health experience of its founders.
The TessArray® RPM (Resequencing Pathogen Microarray) technology is a turnkey Research Use Only device. TessArray RPM technology is being used to develop new applications for detection and identification of respiratory agents (RPM-Flu), tropical and emerging infectious agents (RPM-TEI), and hemorrhagic fever viruses (RPM-HFV), all as research applications, not cleared, approved, or authorized for in vitro diagnostic use to diagnose infected patients. Other products are in development for the detection of nosocomial, food borne, gastrointestinal and blood borne pathogens and porcine and equine infectious diseases.
TessArae, a privately held company, is headquartered in Potomac Falls, VA. For more information about TessArae, please visit the company’s website at www.tessarae.com or by e-mail at email@example.com.
NOTE: TessArae®, TessArae & Vertical Mosaic Design®, TessArray®, and TessArray & Horizontal Mosaic Design®, and Move Beyond PCR® are registered trademarks and registered service marks owned by TessArae, LLC.
Affymetrix technology is used by the world’s top pharmaceutical, diagnostic, and biotechnology companies, as well as leading academic, government, and not-for-profit research institutes. More than 1,800 systems have been shipped around the world and more than 20,000 peer-reviewed papers have been published using the technology.
Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Cleveland, Ohio, and Singapore. The company has about 1,100 employees worldwide and maintains sales and distribution operations across Europe and Asia. For more information about Affymetrix, please visit the company’s website at www.affymetrix.com.
All statements in this press release that are not historical are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act as amended, including statements regarding Affymetrix’ “expectations,” “beliefs,” “hopes,” “intentions,” “strategies,” or the like. Such statements are subject to risks and uncertainties that could cause actual results to differ materially for Affymetrix from those projected. These and other risk factors are discussed in Affymetrix’ Form 10-K for the year ended December 31, 2008, and other SEC reports for subsequent quarterly periods.
NOTE: Affymetrix, the Affymetrix logo, and GeneChip® are registered trademarks of Affymetrix Inc. All other trademarks are property of their respective owners.