Avellino announced that the company has developed a novel multi-panel RT-PCR-based virus assay, AvellinoCoV2-Respiratory, which has been validated following the FDA’s Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing CLIA guidelines. The AvellinoCoV2-Respiratory assay is a noninvasive differential diagnostic test that accurately detects SARS-CoV-2/COVID-19, SARS-like coronavirus and influenza A, influenza B, influenza C. Physicians can order this assay now to optimize patient management and initiate the optimal treatment strategy.
Cell samples are collected by swabbing a patient’s nose. Samples are analyzed in Avellino’s CLIA certified high-complexity molecular testing laboratory facility, which has performed over 1.5 million genetic and molecular diagnostic tests, including 600,000 AvellinoSARS-CoV-2/COVID-19 (AvellinoCoV2) tests since March 2020. In addition, the Avellino Lab has been ranked number one* by the State of California for fast turnaround time with most results delivered within 24 hours to physicians and patients.
“We started as one of the first independent labs with our own FDA EUA for SARS-CoV-2/COVID-19 testing and now we’ve expanded our capabilities to include other serious respiratory viruses. This is another great achievement for Avellino that will benefit the healthcare community and the public in general,” Avellino Group Chairman Gene Lee said in a company news release. “With our new AvellinoCoV2-Respiratory panel, physicians have a single test to let them know if their patient has the virus that causes COVID-19 or the flu due to an influenza strain. As we approach the cold and flu season, this is an extremely valuable diagnostic test that will help physicians accurately determine an immediate treatment course and patient quarantine requirements with total confidence.”
Mr. Lee also noted that this is just the first expansion of the AvellinoCoV2 test. “Viral and respiratory threats soar in the winter months. We are looking forward to the next expansion of our panel in December that will continue to give physicians fast and accurate answers so that they may rapidly determine targeted treatments. This next panel will detect such highly communicable viruses such as H1N1, H2N3 and respiratory syncytial virus (RSV). ”
Professor Tara Moore, Chief R&D Officer added, “The AvellinoCoV2-Respiratory test expands on the company’s existing AvellinoCoV2 Coronavirus RT-PCR testing platform, allowing a differential diagnosis for flu-like symptoms as caused by SARS-CoV2 or an Influenza A B or C virus. We continue to assess both RT-PCR testing technologies and rapid point of care (POC) tests, designing our own tests in line with the California State Testing Task Force and UK task force guidance. We need more testing globally, but we also need to be sure that the testing we are providing is as accurate and well-targeted as possible. With the addition of the AvellinoCoV2-Respiratory assay to our portfolio, we once again show we are continuously developing new premium platform molecular diagnostic tests, and proactively seeking new and innovative ways to help physicians succeed and patients feel confident that they are receiving the answers they need in order to be well, interact safely with their families and protect their communities when they are in public spaces.”