By Kirell Lakhman
IQuum has received 510(k) clearance for its Liat influenza A/B assay and Liat analyzer — good timing since flu season is a couple of months away and it will give clinical labs a nice runway to consider using it.
Designed to detect and discriminate between the two strains, the multiplex real-time RT-PCR-based test cab yield results in around 20 minutes in CLIA moderate-complexity labs.
The approval comes a little more than a year after the Marlborough, Mass.-based company was one of five test makers to obtain FDA Emergency Use Authorizations for in vitro diagnostics that identify patients infected with the 2009 H1N1 influenza A virus.
Influenza testing is a lucrative indication for labs in susceptible regions of the country, mostly the northern states. The bug is believed to infect between 5 percent and 20 percent of the US population each year and cause more than 200,000 hospitalizations and as many as 49,000 deaths, according to CDC.
Its A, B, 2009 H1N1, and H3N2 strains are considered to be the predominant seasonal viruses.
Many labs use rapid immunoassays to identify the virus, but IQuum claims studies have shown that such tests have a sensitivity of between 10 percent and 70 percent.
By comparison, the company said the Liat test "substantially matches time-to-result and ease-of-use of rapid immunoassays" and is "the only test that has equivalent or better sensitivity and specificity as current lab-based nucleic acid tests."
The Liat analyzer, meantime, integrates sample-volume metering, has on-board internal control, advanced error diagnostics, and automated data interpretation. It measures around 4.3 inches x 8 inches.
Both products are also CE Marked.
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