The U.S. Food and Drug Administration (FDA) is taking more swift action to grant special “emergency use authorizations” for equipment and testing, which could help increase testing for new coronaviruses in the United States, where new coronary testing capabilities are considered lagging,media techCrunch reported. One type of test that the FDA has just approved can help expand the availability of front-line testing in hospitals and clinics where patients are being cared for, without having to travel to and from specialized diagnostic laboratories.
The Cepheid COVID-19 test approved by the agency this week also has the advantage of running with or without a nasopharyngeal swab. It is also molecular-based, PCR-based testing with high accuracy, just as laboratory-based testing is already being done by various u.S. agencies, but it uses the company’s GeneXpert machine to produce results in the field. (This is basically a diagnostic printer that is the same size as an inkjet printer.) )
Cepheid says its GeneXpert microlab has used 23,000 microlabs worldwide, about 5,000 of which are in the United States. The company’s hardware has been tested for flu for years and is highly reliable. The system’s new COVID-19 testing, which will begin next week, will be provided by The Sunwell-based Molecular Diagnostics.
Testing in the United States has increased over the past week, thanks in large part to extensive efforts to expand usability, particularly in hard-hit areas such as New York State. However, more testing is still needed because availability restrictions mean that in fact some serious cases are actually detected primarily, often requiring confirmation of contact tracing or increased risk evidence. If you want to really extend the scope of testing to the point where it can be done, solutions like Cepheid’s and other alternative tests, such as Scanwell’s upcoming test of antibodies in human blood, are urgently needed.