FDA Approves Molecular Respiratory Virus Panels

Implications: Influenza and respiratory syncytial viruses (RSV) result in a significant number of hospitalizations and deaths.  According to the CDC, influenza alone causes over 200,000 hospitalizations and 36,000 deaths annually.  Quick diagnosis and proper treatment can lead to shorter hospital stays and lower costs.  The FDA recently approved two new molecular respiratory tests.  Since there are significant differences between the two companies' multiplex panels, one may have a competitive advantage and enable it to build a leadership position in the RSV market segment.

Analysis: The FDA recently approved two new respiratory multiplex panels.  This January ProFlu+ (Prodesse, Inc., Milwaukee, WI) and xTAG (Luminex Molecular Diagnostics, Toronto, CAN) were cleared to market their respective tests.  The Luminex and Prodesse tests take different approaches to in terms of menu, turnaround time, technologist involvement and technology.  As an example, ProFlu+ is a closed tube system, as opposed to Luminex's open tube format.  An open tube format lends itself to contamination and user safety issues.  In addition to the differences between Luminex and Prodesse panels, more companies are preparing to enter the respiratory virus market.

As with other molecular diagnostic tests, there is a substantial improvement in selling prices and margins compared to conventional immunoassay and other esoteric reference lab tests..  A Kansas City lab offers the xTAG panel to its customers for $396/test.

Influenza and respiratory syncytial viruses (RSV) result in a significant number of hospitalizations and deaths.  According to the CDC, influenza alone causes over 200,000 hospitalizations and 36,000 deaths annually.  Quick diagnosis and proper treatment can lead to shorter hospital stays and lower costs for both hospitals and third party payors alike.

According to a recent report from a leading healthcare market research group, the worldwide market for molecular diagnostics was $18 billion in 2006 and is forecasted to grow to over $92 billion in the next ten years.  The US is forecasted to account for approximately half of this revenue.  For detailed information on the companies mentioned above, competitive advantages and the high growth molecular diagnostics market; please contact your GLG representative to schedule an individual consult.