The slow process to getting rapid COVID-19 tests approved by the FDA

A top national scientist speaks out against the FDA, saying the agency is too slow to push out new COVID-19 tests leading to outbreaks and costing us lives. Now, the FDA responds.

When the pandemic began, Owen Kaye-Kauderer and his team knew how to help. Kaye-Kauderer is the Cofounder and Chief Business Officer of Detect.

“That meant building the test that we knew that was needed, which was a home test that was accurate, and fast and affordable and scalable,” he said.

His team created the “Detect test.” This test could be available by fall, just in time for the next predicted surge in cases.

The only thing they need is an EUA  from the FDA.

“Unless our expectations are wildly off, we hope to receive authorization in the coming weeks, months. The FDA has been really collaborative, helpful and engaged with our submission,” Kaye-Kaudereer said.

However, not everyone agrees. Dr. Michael Mina is an Epidemiologist with Harvard’s T.H. Chan School of Public Health.

“It’s very, very unfortunate when our regulatory agency is, which is meant to help protect Americans, is really at the center of preventing Americans from getting tools that will help limit the spread of an infection like SARS-CoV-2 and COVID-19,” said Dr. Mina.

Havard’s Dr. Mina says that the FDA’s delay in getting COVID-19 tests out has cost the country hundreds of thousands of lives.

“The only bottleneck in all of this is the FDA. And I think it needs a deep investigation of what’s going wrong there. And why a real question of why,” said Dr. Mina.

But, the FDA says it is approving those at-home tests and more are on the way.

Dr. Tim Stenzel is the Director of the Office of In-Vitro Diagnostics and Radiological Health for the FDA.

“We’ve already authorized 331 tests as of yesterday. And 44 of them are home collection devices. We have three authorized at-home tests. And those are tests that are entirely done in the home. One of them is OTC as well. We’re going to see a lot more of those coming down the pipeline,” Dr. Stenzel said.

The FDA had this to say, in a statement:

“The characterization that FDA may be “sitting” on test applications is not true; if a test has good data showing it works, we will authorize it, as we have done with many tests already.The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. Since the start of the pandemic, we have authorized over 300 tests and collection kits, including more than three tests/collection kits that allow for at-home use as well as 14 antigen tests. The FDA will continue to support innovation in testing and provide flexibility to test developers with the goal of increasing the availability of accurate and reliable tests for all Americans.”  

In the meantime, the Detect team uses the wait time to innovate their design.

“We’re actually developing what’s called a multiplex test. So looking for both COVID-19 and flu,” said Kaye-Kauderer.

That makes this test well worth the wait.

Dr. Mina informally advises the Biden Administration and says that The White House wants to increase access to testing. However, the White House is deferential to the FDA so it cannot speed up the process to get more tests out.