The FDA has authorized its first rapid, point-of-care diagnostic for the novel coronavirus—allowing physicians in hospitals, clinics and emergency rooms to test a sample for the disease in about 45 minutes.
“During this time of increased demand for hospital services, clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to healthcare facilities,” Cepheid’s chief medical and technology officer, David Persing, said in a statement.
“Approval of Cepheid system for rapid point of care #COVID19 testing is key milestone,” wrote former FDA Commissioner Scott Gottlieb in a tweet. “We need other point of care tests like swabs that give readable results. Testing and serology are key to complementing population based mitigation with case containment.”
Its cartridge-based design, containing all necessary reagents, is similar to Cepheid’s previous diagnostics for influenza and respiratory syncytial virus and accepts nasopharyngeal swab samples as well as nasal aspirates and washes.
Additionally, by searching for multiple regions of the coronavirus’ genome, Persing said the test is designed to detect both current and future variants of the infection.
“Our automated systems do not require users to have specialty training to perform testing—they are capable of running 24/7, with many systems already doing so today,” said Cepheid President Warren Kocmond.
News source: fiercebiotech.com