Luminex Corporation announced that it has received FDA clearance for the ARIES Flu A/B & RSV Assay. This is the second assay the FDA has cleared for use on the Luminex ARIES System.

The ARIES Flu A/B & RSV Assay is a rapid, accurate method for the detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) from nasopharyngeal swab (NPS) specimens using the ARIES(R) System.

The ARIES Flu A/B & RSV Assay delivers results in less than 2 hours for the detection and differentiation of three key respiratory pathogens: influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) using a sample to answer platform. This new assay also allows for panel customization with the unique ability to only report the results of interest.

"Clinical labs everywhere are trying to accomplish more with less these days, so we need each instrument to perform more tasks," said Dr. Stefan Juretschko, Director, Infectious Diseases Diagnostics, Northwell Health. "The ARIES platform lets us run samples as they come in and turn results around quickly. With FDA-cleared assays as well as the ability to run lab-developed tests, it offers us unmatched flexibility."

"In the battles clinicians wage to fight infectious disease, accurate and quickly actionable diagnostic test results are critical for success. The ARIES Flu A/B & RSV Assay requires very limited hands-on time that accelerates the time to result and provides for increased accuracy," said Nachum "Homi" Shamir, President and CEO of Luminex Corporation. "We are proud to have received our second FDA clearance for an ARIES assay, are delighted that these new clinical tests are being embraced by our customers, and look forward to further expansion of our ARIES menu."

Luminex has also received FDA clearance for the ARIES HSV 1&2 Assay for use on the ARIES Systems. Both the HSV 1&2 and Flu A/B & RSV assays have also received CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices.

ARIES Systems are sample to answer molecular diagnostic systems designed to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into today's lean laboratory environment. ARIES uses internal barcode scanning and other advanced features to minimize operator errors. Independent modules support from one to six cassettes, allowing for both STAT and Batch testing of IVD assays and laboratory developed tests (LDTs) with MultiCode Reagents when using a universal assay protocol. An integrated touchscreen PC eliminates the need for a separate computer, standalone keyboard, and mouse, maximizing valuable bench space.

The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid from nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C.