Summary
Quest Diagnostics subsidiary Focus Diagnostics has received a second FDA Emergency Use Authorization for its H1N1 molecular diagnostic test. Marketed under the name Simplexa Influenza A H1N1, it can now be used on 3M's Integrated Cycler by CLIA high-complexity laboratories for the duration of the emergency period.
Analysis
The recent FDA Emergency Use Authorization (EUA) granted to Quest Diagnostic's subsidiary Focus Diagnostics increases the number of molecular diagnostic systems approved to run the company's Simplexa Infulenza A H1N1 molecular diagnostic test to three. The EUA enables Focus to market its test to 3M's Integrated Cycler system, which has not been cleared by the FDA. Earlier in the year, Focus received an FDA EUA to market its Simplexa test to users of Roche Diagnostics and Life Technologies molecular diagnostics systems.
The implication of this new EUA is that it expands the number of potential customers for Focus Diagnostic's Simplexa test. Although the number of labs running high-complexity molecular diagnostic tests remains well below that of labs running routine clinical assays, the forecasted spread of H1N1 could bode well for Focus Diagnostics and its owner Quest.
For more information on the companies mentioned above, rapid and molecular H1N1 diagnostic tests and the high growth molecular diagnostics market, please contact your GLG representative today and schedule an individual consult.
