Coronavirus: Sunnyvale firm gets FDA approval for first rapid test with 45-minute detection time
The automated systems do not require users to have specialty training to perform testing and will begin shipping next week
The United States Food and Drug Administration (FDA) announced it has authorized the use of the first rapid diagnostic test that could detect the novel coronavirus (COVID-19) in approximately 45 minutes.
Developed by Cepheid which made the announcement this week, the test is built to run on its automated GeneXpert hardware, with more than 23,000 tabletop systems installed worldwide and over 5,000 in the US, according to the company.
"Cepheid currently has nearly 5,000 GeneXpert Systems in the US capable of point-of-care testing and for use in hospitals," said Cepheid President Warren Kocmond. "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."
"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. 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," said Dr David Persing, MD, PhD, Chief Medical and Technology Officer at Cepheid.
"By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future variants of SARS-CoV-2, we have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly," Persing added.
Based in Sunnyvale, California, Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing and marketing accurate yet easy-to-use molecular systems and tests. Cepheid will begin shipping the new test from next week.
Cepheid claims that by automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases.
The announcement comes just as the United States stepped up testing efforts. However, many have claimed that their test results take too long to deliver, while others have claimed they never received their results.
Aside from critically ill patients who are hospitalized, the physician said the Massachusetts Department of Public Health is only approving testing for people who have been exposed to someone who has already tested positive or who has traveled to one of the five heavily impacted countries outside the US in the past 14 days, which mirrors CDC guidelines.
"Even if the patient were around and exposed to someone coughing, sick, sneezing, I cannot give them a coronavirus test," a doctor told CNN on the condition of anonymity. "We are being crippled by our department of public health and the CDC on our ability to combat this pandemic."
Globally, there are 307,613 confirmed cases of the COVID-19 virus with more than 13,000 confirmed deaths. In the United States, there are more than 27,069 confirmed cases with a death toll of 340.