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FDA authorizes first rapid, 'point of care' coronavirus test
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03/21/20 01:17 PM EDT
https://thehill.com/policy/healthcare/488807-fda-authorizes-first-rapid-point-of-care-coronavirus-test
The Food and Drug Administration (FDA) has approved the first coronavirus diagnostic test that can be conducted entirely at the point of care.
The test from California-based Cepheid will deliver results in about 45 minutes - much faster than current tests that require a sample to be sent to a centralized lab, where results can take days.
The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide, of which 5,000 are in the U.S., the company said. The systems are already being used to test for conditions such as HIV and tuberculosis.
The systems do not require users to have specialty training to perform testing and are capable of running around the clock.
"An accurate test delivered close to the patient can be transformative" and can "help alleviate the pressure" that the COVID-19 outbreak has put on health facilities, David Persing, Cepheid's chief medical and technology officer, said in a statement.
"People in general are frustrated with the turnaround time. They don't know their status until days later. Knowing your status quickly ... will allow much better decisionmaking" and help doctors choose the best treatment, Persing said in a video on the company's website.
The test initially will be used primarily by hospitals, the company said, but the FDA's "emergency use authorization" covers all "patient care settings," including doctors' offices.
The test will begin shipping next week.
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Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test
First Rapid, Point-of-Care and Near-Patient Molecular Test for Detection of Virus that Causes COVID-19
SUNNYVALE, Calif., March 21, 2020 /PRNewswire/ -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19. The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert® Systems worldwide, with a detection time of approximately 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 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, Ph.D., 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."
"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."
The test will begin shipping next week. For more information about Cepheid's Xpert Xpress SARS-CoV-2 test, please visit www.cepheid.com/coronavirus.
About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's (NYSE: DHR) Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. 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. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
For Cepheid Media Inquiries:
Darwa Peterson
darwa.peterson@cepheid.com
Media Contacts:
Jason Spark,
CanaleComm, jason@canalecomm.com
Cammy Duong,
CanaleComm, cammy@canalecomm.com
SOURCE Cepheid
Related Links
http://www.cepheid.com
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