FDA clears IQuum's Liat influenza A/B assay, analyzer

IQuum, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the Liat™ Influenza A/B Assay and the Liat™ Analyzer. This molecular diagnostic test is an automated sample-to-result multiplex real-time RT-PCR assay for the detection and discrimination of influenza A and influenza B in approximately 20 minutes. The test is intended for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform "moderate complexity" tests, enabling its use in hospital labs or other near-patient settings.

"The Liat Influenza A/B Assay presents a revolutionary improvement in the speed and ease-of-use of nucleic acid testing," said Dr. Shuqi Chen, Chief Executive Officer of IQuum, Inc. "IQuum's goal is to provide sophisticated nucleic acid tests that can be performed in near-patient settings and deliver accurate results to physicians and patients instantly. This regulatory clearance demonstrates the capability of the Liat system to realize this goal."

Influenza is a highly contagious acute respiratory illness that affects between 5% and 20% of the U.S. population each year, leading to more than 200,000 hospitalizations and as many as 49,000 deaths, according to the U.S. Centers for Disease Control and Prevention (CDC). Influenza A, including subtypes A/2009 H1N1 and H3N2, and influenza B, are considered to be the predominant seasonal influenza viruses. Current near-patient influenza testing is performed using rapid immunoassays. However, studies have shown that such immunoassays have a sensitivity of only 10-70%.

The Liat Influenza A/B Assay is currently the only test that has equivalent or better sensitivity and specificity as current lab-based nucleic acid tests, while substantially matching the time-to-result and ease-of-use of rapid immunoassays. Having an operator hands-on time of less than 1 minute and a total time-to-result of approximately 20 minutes, the Liat test can be performed on-demand in hospital near-patient settings, providing physicians with accurate and timely results. The Liat system integrates multiple intelligent features, such as sample volume metering, on-board internal control, advanced error diagnostics, and automated data interpretation to ensure the quality of results when operated by minimally trained users.