Healthcare Industry News: IPLEX
News Release - August 23, 2011
IQuum Receives FDA 510(k) Clearance for Liat(TM) Influenza A/B Assay for Influenza Molecular Diagnostics in Approximately 20 MinutesMARLBOROUGH, Mass.--(Healthcare Sales & Marketing Network)-- 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)1. 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%2.
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.
The Liat Influenza A/B Assay and the Liat Analyzer are also available as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. For more information, please visit: http://www.iquum.com/products/faba.shtml.
The development of the Liat Influenza A/B Assay was partially funded and supported by grants from the National Institute of Allergy and Infectious Diseases, National Institute of Health.
About the Liat Analyzer
IQuum’s Liat Analyzer is a sample-to-result molecular diagnostic system that refines the testing process to three simple steps: (1) collecting a raw biological sample into a Liat Tube, (2) scanning the tube’s barcode to identify the test and track the patient sample, and (3) inserting the tube into the Liat Analyzer. The analyzer automatically executes all the required assay steps and reports test results on the built-in touch screen. No manual reagent addition, operator intervention or data interpretation is required. Results are returned in as little as 20 minutes. The Liat Analyzer’s small size (~4.3” x 8” footprint), self-contained design, and robust error prevention features, will make it ideally suited for near-patient or on-site molecular diagnostics.
About IQuum, Inc.
IQuum is the leader in developing lab-in-a-tube technology, a novel biological sample testing platform which provides revolutionary benefits to a broad cross section of the bioassay market. The Company's proprietary technology enables the non-specialized personnel to perform more sophisticated biological sample testing in any setting with greater speed. Founded in 1998, the Company is commercializing its lab-in-a-tube technology and products for the clinical diagnostics, bio-defense, and industrial testing markets. For more information, please visit www.IQuum.com.
1. CDC Seasonal Influenza Question & Answer. http://www.cdc.gov/flu/about/qa/disease.htm. Accessed July 24, 2011.
2. Hurt AC et al. Influenza & Other Respiratory Viruses 2009;3(4):171-76)
This Release contains forward-looking statements, including statements regarding IQuum and development of IQuum’s products. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this Release. IQuum undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this Release or to reflect the occurrence of unanticipated events.
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