|Alice Jacobs Nesselrodt, MD|
IntelligentMDx, Cambridge, Mass, has received FDA clearance for its automated molecular diagnostic test that detects influenza A, influenza B, and respiratory syncytial virus (RSV) directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection.
Reactivity studies demonstrated that the IMDx Flu A/B and RSV for Abbott m2000 assay is capable of detecting at least 55 different strains of influenza A, influenza B, and RSV, including variant strains from various geographical locations, including H1N1, H3N2, and recently emerging H3N2 variant strains.
The test is a qualitative, reverse transcription polymerase chain reaction (rT-PCR) test for rapid detection of influenza A and B and RSV.
It is fully automated and can analyze up to 94 patient samples per run. Minimal hands-on time is required as results are obtained directly from an upper respiratory tract specimen from a symptomatic patient.
This is the second test from IMDx’s portfolio of molecular diagnostics to be cleared by the FDA for use on Abbott’s fully automated m2000 platform and its second FDA clearance in 5 weeks. (The IMDx VanR for Abbott m2000 test, which detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE), received clearance in July.)
Alice Jacobs Nesselrodt, MD, chairman and CEO, IMDx, says the company is pursuing regulatory clearances for other tests from its product portfolio.
In 2011, Abbott and IMDx inked a global, multiyear distribution agreement through which IMDx designs, develops, obtains regulatory clearances, and manufactures real-time PCR assays for the Abbott m2000 instrument system.
Some 60 million people become infected with influenza each year, and approximately 125,000 children under the age of 1 are hospitalized annually with RSV infection.