Upper Respiratory Viral Panel Will Include H5N1 and SARS

Tm Bioscience Corporation a leader in the commercial genetic testing market, have developed an upper respiratory viral panel that detects all of the major human respiratory viruses, including H5N1 (Avian Flu) and SARS Corona. The test was developed in collaboration with researchers in Dr. Jim Mahony’s lab at McMaster University in Hamilton, Ontario, Canada. The prototype is currently undergoing optimization and will begin clinical evaluation in the coming weeks. Tm is in discussions with regulators, including the FDA, on preparing IVD submissions for expedited review.

The test was developed using the Tag-It™ Universal Array platform from Tm Bioscience, which enables the rapid production of flexible, high-throughput, low-cost gene-based tests. The test operates on the Luminex xMAP® system (Luminex Corporation, Austin, Texas), a well-established instrument found in many clinical laboratories.

Tm Bioscience plans to launch successive versions of its Upper Respiratory Infectious Disease Panel over time. The first version of the panel, which detects and differentiates among various strains of Respiratory Syncitial Virus (RSV), SARS Corona Virus, Parainfluenza and Influenza Virus A/B including H5N1 (Avian Flu), is undergoing optimization and will be available for evaluation by hospital based laboratories and reference laboratories in early December.

Subsequent versions of the test will be expanded to include additional viruses and may identify specific mutant variants of the H5N1 virus that are capable of human-to-human transmission or that develop Tamiflu® resistance.