It performs PCR tests, the most widely used kind of diagnostic test, which detect the virus’s genetic material. Since it was founded in January 2020, the Southern California startup has rocketed to becoming one of the biggest COVID-19 test providers in the country. The tussle between the FDA and Curative illustrates the tightrope that the regulator is trying to walk: making brand-new tests quickly and widely available during a pandemic while ensuring they are reliable. Some also raised concerns that Curative in particular has more work to do to prove it can be trusted to test at the widespread scale at which it’s currently operating: 1 million tests a week, or 10% of all COVID-19 testing in the US. Other experts are more cautious, saying that in at least some circumstances, high precision is important because even a relatively few undetected cases can be a compounding threat and lead to outbreaks. “Their decision making on Curative is one example.” “The FDA and its deadly regulations around how they are evaluating Covid tests is inadvertently resulting in the loss of thousands of additional lives that need not be lost in this pandemic,” he said by email. Chan School of Public Health who is not involved with Curative, said the FDA appeared to be holding Curative to a nearly impossible standard of sensitivity, based on documents provided by the company. Michael Mina, an epidemiologist at the Harvard T.H. The young company, and scientists who side with it, say it is most crucial to focus on catching people who are at their potentially most contagious, even if it means using a less sensitive test that may fail to pick up on people who are no longer infectious but who have lingering remnants of the virus. That drop-off in ability is relatively unimportant during the pandemic, Curative argues, underscoring a philosophical split in testing. Research done by Curative suggests that its mouth-swab test spots the virus with a high degree of accuracy in the first three weeks of an infection, including in people without symptoms, and with less accuracy for later-stage infections. This week, Curative pushed back with new data that, it claims, validates its approach. That debate came to a head this month when the Food and Drug Administration warned the public that the Southern California company’s tests were possibly missing coronavirus infections. Nearly a year into the US pandemic, the massive startup Curative is embroiled in an ongoing argument with federal regulators: Is it worth having tests that may accurately detect COVID-19 in the early stages of infection, but not as time goes on?
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