NEW YORK (GenomeWeb News) – The US Food and Drug Administration has given 510(k) clearance to IQuum's assay for detecting and differentiating influenza A and B in about 20 minutes, the company announced today.
IQuum's Liat Influenza A/B Assay and Liat Analyzer is an automated sample-to-result multiplex real-time RT-PCR assay intended for use in CLIA-certified laboratories. According to IQuum, it is the only test that has sensitivity and specificity equivalent to or better than current lab-based nucleic acid tests, as well as time to result and ease of use comparable to immunoassays.
The assay, which is also CE marked, requires one minute of operator hands-on time and can achieve results in about 20 minutes, making it appropriate for hospital near-patient settings, the Marlborough, Mass.-based firm said.
"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," IQuum CEO Shuqi Chen said in a statement.