The COVID-19 pandemic highlighted the limited testing capacity of public health and reference laboratories. Unprecedented investments made by the federal government propelled numerous companies and hospitals to expand access to diagnostic tests. As SARS-CoV-2 continued to circulate, the ability of individuals to know their own status became important to interrupt transmission. Programs like RADx Tech increased investment in Point-of-Care (PoC) and over-the-counter (OTC) testing.
Other respiratory viruses’ rates have increased dramatically in 2022 (e.g., influenza, RSV), partially due to increased population movement and decline of masking. An estimated 100,000 die of seasonal influenza annually, mostly affecting the young and old. Although efforts have been made to bring PoC influenza tests to enable prompt initiation of antiviral treatment, existing FDA approved PoC technologies utilizing upper respiratory specimens are antigen tests that have lower sensitivity than molecular testing (RT-PCR). An emerging contingent of developers are developing tests for self-collected nasal swabs for multiplexed influenza testing as well as OTC tests.
Many respiratory viruses produce similar symptoms, and it is crucial to be able to differentiate SARS-CoV-2, influenza A and influenza B, especially during this time when the viruses are co-circulating within the population. Multiplex antigen tests and molecular assays are crucial step towards proper prescription of medication and being proper antimicrobial stewards.
The CIDID played a key role throughout the COVID-19 pandemic as part of the POCTRN network to evaluate over 150 companies as part of the NIH’s RADx Tech Initiative. Over 75 companies have come before our Clinical Review Committee to examine each company’s MedTech and its alignment with use case and unmet need. Our position and expertise places us in a valuable position for collaborations both privately and publicly.