The US Food and Drug Administration (FDA) has approved the use of the first rapid diagnostic test developed by Cepheid, a US based company, that could detect coronavirus in approximately 45 minutes.The authorization was made Friday.
The diagnostic test kits will begin shipping next week, according to a statement from California-based Cepheid, the company manufacturing the tests.
“Our dedicated team at the FDA has been working nonstop to expedite the review and authorization of novel diagnostics during the COVID-19 public health emergency,” said FDA Commissioner Stephen Hahn, M.D. “Today marks an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”
“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 health-care facilities,” said Dr. David Persing, MD, Ph.D., chief medical and technology officer at Cepheid.
“An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources,” Persing added.
Founded in 1996, Cepheid leads in the development of innovative systems that simplify highly complex, multi-stage processes for the detection and analysis of nucleic acids, such as DNA, in samples such as blood, urine, food and industrial water.
This breakthrough is coming as Nigeria reports cases of Chloroquine poisonings after president Trump touted drug claiming FDA had approved it for the treatment of coronavirus. FDA later denied Trump’s claims.
This diagnostic test is expected to help in the timely detection of the virus which will help control the spread.