First point-of-care test to detect coronavirus cleared.
Gilead Sciences is temporarily halting patient access to its experimental drug to treat coronavirus disease (COVID-19) as FDA cleared the first point-of-care test to detect the disease.
Gilead is putting new emergency access to its experimental drug remdesivir on hold “due to overwhelming demand,” Reuters reported. There has been an exponential increase in compassionate-use requests for the drug as spread of the virus in Europe and the US has “flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic,” Gilead says.
However, Gilead is making exceptions for pregnant women and children under 18 with severe COVID-19.
“Enrollment in clinical trials is the primary way to access remdesivir to generate critical data that inform the appropriate use of this investigational medicine,” Gilead says.
Despite the setback, Gilead is “mapping out options to make access to investigational remdesivir more widely available through expedited regulatory processes should it demonstrate the potential to be a safe and effective treatment option based on the results of preliminary clinical trials,” says the pharma maker on its web site.
Gilead is also in discussions with multiple organizations regarding the potential for future trials, the company says.
Meanwhile, FDA issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test (Cepheid).
“The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort,” says HHS Secretary Alex Azar in a press release.
“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,” says FDA Commissioner Stephen Hahn, MD. “Today marks an important step in expanding the availability of testing and, importantly, rapid results."
The point-of-care testing means that results are delivered to patients in the patient care settings such as 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, says Hahn.