While developing a rapid test that detects the coronavirus in someone’s saliva, Blink Science, a Florida-based startup, heard something startling: The Food and Drug Administration had more than 3,000 emergency use authorization applications and didn’t have the resources to get through them…
Some experts say the FDA’s approach to clearing rapid tests has been onerous and overly focused on exceptional accuracy to detect positive results, rather than on what would really benefit people en masse: speedy results. The main use of rapid tests is to screen people so they can safely attend work, school, meetings or gatherings. This screening can then be followed up with a more sensitive, lab-based polymerase chain reaction (PCR) test for diagnosis.
The FDA has authorized just 12 over-the-counter options for rapid tests. But the problems go beyond that agency: The Biden administration recently put $3 billion toward boosting the supply of rapid tests, but public health and industry experts say the government didn’t move quickly enough early in the pandemic to support development and manufacturing.
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