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Inovar, Inc., a full-service Electronics Manufacturing Services (EMS) provider, announces that it has been designated as a “Critical/Essential Supplier” and will stay open during the COVID-19 pandemic.
Inovar’s medical customers, including BioFire, have designated Inovar as critical to their operations and public safety. BioFire’s diagnostic equipment has just been authorized by FDA under an emergency use authorization (EUA) for use by authorized laboratories to diagnose COVID-19 in 45 minutes.
“As a supplier to businesses that are working to support our country against COVID-19, such as BioFire, the raw materials that you are providing are essential to the manufacturing of very important rapid tests that will aid in the detection of COVID-19, and another test currently used in the detection of a broad range of respiratory illnesses. These tests are essential in the fight against this pandemic,” stated Utah Governor Gary R. Herbert in a letter to Inovar.
With more than 25 years of molecular experience, BioFire Diagnostics, LLC sets the standard for molecular diagnostics through its pioneering advances in syndromic infectious disease testing. As BioMérieux’s Global Center of Excellence for Molecular Diagnostics, no other company has FDA-cleared and CE-IVD marked assays for more pathogens. BioFire Diagnostics has produced the easiest, fastest, and most comprehensive multiplex PCR testing available: the BioFire System.
In collaboration with the Department of Defense, BioFire Defense has developed a fully-automated, sample-to-result assay for the specific detection of SARS-CoV-2, the causative agent of COVID-19. This assay is designed to run on both the BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems, delivering results in about 45 minutes. After meeting initial DoD demand, commercial availability under EUA is anticipated in April 2020.
In parallel, BioFire Diagnostics is developing new SARS-CoV-2-specific assays for addition to the BioFire® FilmArray® Respiratory 2 (RP2) Panel. This new panel will be named the BioFire® Respiratory 2.1 (RP2.1) Panel and is being developed for both the BioFire 2.0 and BioFire Torch Systems. In addition to the detection of SARS-CoV-2, the BioFire RP2.1 Panel will detect 21 additional respiratory pathogens to help clinicians quickly rule in and rule out other common causes of respiratory illness in about 45 minutes. Development of the BioFire RP2.1 Panel is also occurring on an accelerated timeline, and submission to the FDA for EUA and 510(k) clearance is anticipated in Q3 of 2020.
Inovar’s Logan and Tecate factories are in full production mode and will stay that way due to the critical medical nature of products the company provides to BioFire and its other medical customers.
To that end, Inovar is working diligently to keep its workplace productive and healthy during the pandemic. Social distancing, fewer interactions and good hygiene help the factories and its employees maintain the quality support that its customers rely upon.
“As the world works to overcome COVID-10, Inovar is doing its part by staying in close contact with BioFire and our other medical customers as we prioritize supplying the materials needed to meet their vital demand,” said Craig Rupp, Inovar Inc. CEO.