FDA approves fast tests for coronavirus as US faces shortages
The FDA has approved two fast tests for the coronavirus that is causing the COVID-19 epidemic, which are able to produce results within hours instead of days.
Testing for the SARS-CoV-2 coronavirus is one of the most effective methods currently available to fight the disease, allowing for identification and quarantine of infected individuals.
But there are not enough tests available to match demand, particularly in the US, and regulators are hurrying through an array of different products to help fight the global epidemic.
On Friday, Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases admitted that the US cannot meet demand for tests.
This stems from a decision by US authorities to run with a test developed by the Centers for Disease Control instead of using a protocol developed by the World Health Organization when the epidemic began to take off in January.
Unfortunately the CDC test was found to be inconclusive shortly after it reached labs, and the US has been playing catch-up since then, CNN reported.
The FDA has been granting emergency use authorisations for tests from Anglo-French biotech Novacyt and US firm Cepheid.
Novacyt’s Primerdesign molecular diagnostics division launched the COVID-19 test for research use only on 31 January, and it gained its European CE mark on 17 February.
Following the FDA’s approval hospitals and labs in the US will be able to use the Primerdesign test for diagnosis of COVID-19.
The company said its test can provide results in less than two hours and tests can be shipped at ambient temperatures because they are freeze-dried.
They can also be used on several lab instrument platforms. Novacyt said that the Indonesian Ministry of Health has also approved its test.
Over the weekend the FDA also authorised the first point-of-care COVID-19 diagnostic from Cepheid.
The company’s Xpert Xpress SARS-CoV-2 nasal swab test will be used in certain specialist laboratories, as well as in patient care settings.
The company said it intends to roll out availability of its point-of-care testing by 30 March following the emergency use authorisation.
The FDA grants emergency authorisations for tests for life-threatening diseases or conditions, where the totality of the evidence suggest products will be effective, and there is no adequate approved and available alternative.
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