Two recently authorized tests alone could boost availability by as much as 13 million tests a day, McKinney said, adding that it would “efficiently review the submissions that will have the biggest impact on the nation’s testing needs.” The agency says it is prioritizing reviews of at-home and point-of-care tests that can be produced in high volumes. … For too long, people thought of testing as an extra and not the core, and it needs to be thought of as the core.”ĭuring the pandemic, the FDA has received more than 4,500 emergency use authorization and related requests for COVID tests, according to FDA spokesperson Jim McKinney. “Should we have had an equivalent of Operation Warp Speed for testing?” asked Mara Aspinall, a co-founder of life sciences fund BlueStone Venture Partners and a board member for OraSure Technologies, which received FDA authorization for an over-the-counter rapid test. 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. The FDA has authorized just 12 over-the-counter options for rapid tests. This screening can then be followed up with a more sensitive, lab-based polymerase chain reaction (PCR) test for diagnosis. The main use of rapid tests is to screen people so they can safely attend work, school, meetings or gatherings. 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. Experts say the paucity of tests and their high prices undermine efforts in the U.S. produced COVID-19 vaccines in record time, but, nearly two years into the pandemic, consumers have few options for cheap tests that quickly screen for infection, though they are widely available in Europe. “It’s just the way our government works,” Hendrix said, which is a challenge for businesses that are “anxious to get started and think they’ve got something that can help.” On the advice of consultants, the company is weighing an alternative route through the FDA to the U.S. “We want to try to avoid the EUA quagmire,” said Peb Hendrix, the startup’s vice president of operations. 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.
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