A top federal scientist sounded the alarm about what he feared was contamination in an Atlanta lab where the government made test kits for the coronavirus, sources familiar with the situation in Atlanta tell me and Axios' Caitlin Owens.
- The Trump administration has ordered an independent investigation of the Centers for Disease Control and Prevention lab, and the manufacture of the virus test kits has been moved, the sources said.
Why it matters: At a time when the administration is under scrutiny for its early preparations for the virus, the potential problems at the lab became a top internal priority for some officials. But the Trump administration did not talk publicly about the Food and Drug Administration’s specific concerns about the Atlanta lab.
- Senior officials are still not saying exactly what the FDA regulator found at the Atlanta lab.
- The CDC lab in Atlanta developed the testing formula for the coronavirus test — which the government says works — and was manufacturing smaller quantities of the testing kits for laboratories around the country. This is where the lab ran into problems, per sources familiar with the situation.
FDA commissioner Stephen Hahn said, in a statement to Axios, that government agencies have already worked together to resolve the problems with the coronavirus tests.
- "Upon learning about the test issue from CDC, FDA worked with CDC to determine that problems with certain test components were due to a manufacturing issue," he said.
- "We worked hand in hand with CDC to resolve the issues with manufacturing. FDA has confidence in the design and current manufacturing of the test that already have and are continuing to be distributed. These tests have passed extensive quality control procedures and will provide the high level of diagnostic accuracy we need during this coronavirus outbreak."
The big picture: The FDA says it now has full confidence in the coronavirus diagnostic kit, but a slew of new cases announced over the weekend suggest the virus has spread throughout the country while the U.S. government tested only a narrow subset of the population for it.
- The U.S. government had admitted to problems with its diagnostic tests — which have put the U.S. well behind China and South Korea in doing large-scale testing of the American public for coronavirus.
- But the U.S. has now tested more than 3,600 people for the virus, according to the Department of Health and Human Services.
The big question: It was not immediately clear if or how possible contamination in the Atlanta lab played a role in delays or problems with testing. Nor was it clear how significant or systemic the contamination concerns may be; whether it was a one-time issue that's easily resolved, or a broader concern involving protocols, safeguards or leadership.
Behind the scenes: The FDA official who visited the Atlanta lab, Timothy Stenzel, is the director of the Office of In Vitro Diagnostics and Radiological Health.
- About a week ago, when HHS Secretary Alex Azar was under extreme pressure over the delays in getting coronavirus testing kits to market, Stenzel traveled to Atlanta to help troubleshoot whatever technical problems might have been occurring with the tests.
- Stenzel was alarmed by the procedures he witnessed in the Atlanta laboratory and raised concerns with multiple CDC officials, per a source familiar with the situation in Atlanta.
- Stenzel is a highly regarded scientist and diagnostics expert. He was on the ground in Atlanta to deal with technical issues and happened to stumble upon the inappropriate procedures and possible contaminants. He is not a laboratory inspector and thus was not charged with producing an inspection report on the lab conditions.
- But he raised the concerns and they have been taken seriously and risen to the highest levels of the U.S. government.
On Thursday afternoon, the concerns about the Atlanta laboratory were raised in a conference call that included senior government officials from multiple agencies including the FDA, HHS, the CDC, and the National Institutes of Health.
Go deeper: Read our full story in the Axios stream