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More Good News On COVID-19.

The good news just keeps on coming….

A company by the name of Cepheid has received FDA approval for a new test that gives results in less than an hour and not hours or days.

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.

Secondly, the FDA has approved the “compassionate use” of some drugs that are thought to be effective in treating COVID-19:

We’ve been talking about chloroquine for at least a week now. The anti-malaria has been used in France and other Asian countries. A recent study conducted by Thomas R. Broker, (Stanford PhD), James M. Todaro (Columbia MD), and Gregory J. Rigano, Esq., in consultation with Stanford University School of Medicine, UAB School of Medicine, and National Academy of Sciences researchers, shows that over the counter anti-malaria pills Chloroquine may be highly effective at treating coronavirus COVID-19.

Chloroquine and his sister drug, hydroxychloroquine, have been used to treat malaria since Word War II. Now, the Food and Drug Administration (FDA) has approved the ‘compassionate use’ of chloroquine to treat coronavirus patients in the United States.

Stephen Hahn, commissioner of the Food and Drug Administration (FDA), said that allowing COVID-19 patients the “right to try” would provide the FDA with additional data on the effectiveness of the drugs against coronavirus, potentially speeding up its release to the public. Hahn said drugs like remdesivir are “going through the normal process,” but will be made available for “compassionate use,” allowing doctors to have emergency access to the drugs if requested.

The idea behind the compassionate use is not new. It is a longstanding FDA program that allows for a physician to use an investigational drug in a patient under a protocol that undergoes review by an institutional review board and the FDA itself, while in addition enabling the agency to collect data.

Both of these items are good, positive steps, especially the use of chloroquine and hyperchloroquine. The reason for this is that the more the drug(s) is used, the more data that can be gotten. If the drug proves effective, as studies and use here in the US and abroad have shown, the beginning of the end may well be in sight. If not, we will have to go elsewhere and down a different path.

The point is that we should be making rational, science based decisions and not going off half cocked.

One thing the pandemic has shown is that many regulations that are on the books are not needed. Those regulations have served as barriers to quick responses from scientists, academics and industries.

It sounds crass, but maybe the best thing that COVID-19 may kill are those regulations which prevent the rapid response of the country in times like this.



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