H1N1 swine flu detection test TessArray RM-Flu cleared for emergency use by US FDA

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.

TessArray RM-Flu test, a diagnostic kit to detect 2009 H1N1 influenza A (swine flu) virus, has been granted Emergency Use Authorization by US FDA, the company said in an official release.

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.

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.

TessArray RM-Flu test is performed on throat swabs taken from patients with symptoms of respiratory infection.

TessArray RM-Flu assay directly generates genomic sequence from multiple influenza virus genes to identify the 2009 H1N1 Influenza A virus strain in a single test.

“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,” stated Klaus Schäfer, MD, MPH, president and CEO of TessArae.
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.

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.

Headquartered in Potomac Falls, VA, TessArae is a privately held company.

TessArae is a 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.

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.