Author: Elleen Kane, M.A., APR, ASPR Communications Team
Each flu season health care providers, sick patients and their families can wait days to hear whether a patient has a viral infection. Specimens are often shipped to reference laboratories for molecular testing that requires specialized training and procedures. During the 2009 H1N1 pandemic, clinicians waited for results as labs processed thousands of specimens in a short time. Concerned about what would happen in a more severe pandemic, a BARDA public-private partnership is helping solve this problem for seasonal and pandemic flu sufferers alike.
Since 2010, BARDA has funded an innovation contract with 3M and Focus Diagnostics (a wholly owned business of Quest Diagnostics). The work BARDA funded under the contract led to a recent FDA 510(k) clearance for the Focus Diagnostics Simplexa Flu A/B & RSV Direct Test on the 3M™ Integrated Cycler. The test also received a CLIA moderate complexity determination which means that the test can be made available to a greater range of health care professionals than previous tests and can provide near-patient, quality, molecular testing at community hospitals and clinics.
The new clinical diagnostic frees labs from costly, time-consuming extraction procedures, making it easier and faster for laboratories to perform sensitive testing for influenza virus and for respiratory syncytial virus (RSV). The tests can be done locally without delays from transporting specimens to distant labs.
This project’s innovative concept was to eliminate the need for separate sample preparation steps by using a new assay chemistry and disc design with the Integrated Cycler. The Simplexa Flu A/B & RSV Direct test takes a sample directly into an 8-well disc that resembles a CD. With simplified assay procedures and user-friendly software, these tests can be performed in CLIA moderate complexity laboratory settings, as opposed to high complexity reference laboratory settings.
BARDA’s Influenza Division provided funding to 3M in partnership with Focus Diagnostics through a Strategic Science and Technology Division innovations contract for 2 years and $5.9 million. BARDA’s Science and Technology Platforms Applied to Medical Countermeasure Development Program supports new technology platforms that could lead to more effective medical countermeasure products.