But Nuzzo and other researchers are concerned because the CDC and public health labs are not typically where doctors order tests. This work is typically done by large clinical laboratories run by companies and universities, which are not licensed to test for avian flu.
As the outbreak expands — with at least 114 herds infected in 12 states as of June 18 — researchers said the CDC and FDA are not moving fast enough to remove barriers that prevent clinical laboratories from carrying out tests. In one case, diagnostics company Neelyx Labs was waiting on a request for more than a month.
“Clinical laboratories are part of the nation’s public health system,” said Alex Greninger, deputy director of the University of Washington Medicine’s Clinical Virology Laboratory. “Drag us into the game. We’re stuck on the bench.
The CDC recognized the need for clinical laboratories in a June 10 memo. He calls on the industry to develop tests to detect the H5 strain of the avian flu virus, the one that circulates among dairy cattle. “The limited availability and accessibility of diagnostic tests for influenza A(H5) poses several problems,” the CDC wrote. Points include a shortage of tests if demand increases.
Researchers including former CDC Director Tom Frieden and Anthony Fauci, who led the nation’s response to COVID-19, cite testing failures as one of the main reasons the United States is doing so poorly. struggling with COVID. If COVID testing had been widely available in early 2020, they say, the United States could have caught many cases before they turned into outbreaks that led to business closures and cost lives.
In a paper published this month, Nuzzo and a group of colleagues noted that the problem was not in testing the capacity but in the failure to deploy that capacity quickly. The United States has reported excess mortality eight times higher than other countries with advanced laboratories and other technological advantages.
A WHO-approved COVID test was available in mid-January 2020. Rather than use it, the United States stuck to its own multi-step process, which took several months. Namely, the CDC develops its own test and then sends it to local public health labs. Eventually, the FDA authorizes testing by clinical diagnostic laboratories serving hospital systems, which must then scale up their operations. It took a long time, and people died amid outbreaks in nursing homes and prisons, waiting for test results.
In contrast, South Korea immediately deployed testing in private sector laboratories, allowing it to keep schools and businesses open. “They said, ‘Get ready, guys; we’re going to need a ton of testing,” said Frieden, now president of the public health organization Resolve to Save Lives. “You have to have in-game ads.”
Nuzzo and colleagues outline a step-by-step strategy for deploying testing during a health emergency, in response to errors made evident by COVID. But in this bird flu epidemic, the United States is weeks behind on this strategy.
Thorough testing is essential for two reasons. First, people need to know if they are infected so they can be treated quickly, Nuzzo said. Over the past two decades, about half of the 900 people known worldwide to have contracted bird flu have died from it.
Although the three farmworkers diagnosed this year in the United States had only mild symptoms, such as a runny nose and inflamed eyes, others may not be so lucky. Tamiflu flu treatment only works when given soon after symptoms appear.
The CDC and local health departments have tried to step up testing for bird flu among farmworkers, asking them to get tested if they feel sick. Farmworker advocates list several reasons why their outreach efforts are failing. Outreach might not be in the languages spoken by farmworkers, for example, nor address concerns such as job loss.
If people who live and work around farms simply seek medical attention when they or their children become ill, these cases could go unnoticed if doctors send samples to their regular clinical laboratories. The CDC has asked doctors to send samples from people with flu symptoms who have been exposed to livestock or poultry to public health laboratories. “If you work on a farm with an outbreak and are concerned about your well-being, you can get tested,” Shah said. But sending samples to public health requires knowledge, time and effort.
“I really worry about a testing program where very busy clinicians have to figure this out,” Nuzzo said.
The other reason to involve clinical laboratories is so that the country can step up testing if bird flu is suddenly detected in people who did not catch it from livestock. There is no evidence that the virus has started to spread among people, but that could change in the coming months as it evolves.
The quickest way to get clinical labs involved, Greninger said, is to allow them to use a test that the FDA has already authorized: the CDC’s avian flu test. On April 16, the CDC opened this possibility by offering accredited laboratories royalty-free licenses for components of its avian flu tests.
Several commercial laboratories have applied for licenses. “We want to prepare before things get crazy,” said Shyam Saladi, chief executive of diagnostics company Neelyx Labs, which has offered COVID and mpox tests during shortages linked to these outbreaks. His experience over the past two months reveals the types of obstacles that prevent labs from moving quickly.
In email exchanges with the CDC, shared with KFF Health News, Saladi clarifies the labs’ desire to obtain relevant licenses for the CDC test, as well as a “right to reference” CDC data in its application authorization from the FDA.
This “right to reference” allows a company to more easily use a test developed by another. This allows the new group to ignore certain analyzes performed by the original manufacturer, asking the FDA to review the data contained in the original FDA application. This was commonplace with COVID testing at the height of the pandemic.
At first, the CDC seemed eager to cooperate. “A right of reference to the data should be available,” wrote Jonathan Motley, a patent specialist at the CDC, in an email to Saladi on April 24. Over the next few weeks, the CDC sent him information about transferring his licenses to the CDC. company, and on the test, which prompted Neelyx researchers to purchase test components and test the CDC process on their equipment.
But Saladi became increasingly concerned about the possibility of referencing CDC data in the company’s FDA application. “Do you have an update regarding the reference fee? » he asked the CDC on May 13. “If there are any potential sticking points on this, would you mind letting us know, please?”
He asked this question several times over the following weeks, as the number of bird flu-infected flocks increased and new cases among farm workers were announced. “Given that it is May 24 and the outbreak has only grown, can the CDC provide a date when they plan to respond?” Saladi wrote.
The CDC ultimately signed a licensing agreement with Neelyx but informed Saladi that it would not, in fact, provide the reference. Without it, Saladi said, he couldn’t move forward with the CDC test — at least not without more material from the agency. “It’s really frustrating,” he said. “We thought they really intended to support the development of these tests in case they were needed.”
The CDC’s Shah said test manufacturers should generate their own data to prove they are using the CDC test correctly. “We are not facing such a shortage that we have to cut corners,” he said. “Quality reigns supreme.”
The CDC has granted licenses for its tests to seven companies, including Neelyx — although none have been authorized to use them by the FDA. Only one of these companies applied for the reference right, Shah said. Laboratories can be helped by additional equipment that the agency is currently developing, to allow them to complete the analyses, even without a reference.
“This should have happened sooner,” Saladi told KFF Health News when informed of the additional pending documents from the CDC. “There has been no communication about this.”
Greninger said the delays and confusion are reminiscent of the early months of COVID, when federal agencies prioritized caution over speed. Testing accuracy is important, he said, but over-control can cause harm during a fast-moving outbreak like this. “The CDC should try to open this activity to laboratories that are national in scope and have a good reputation,” he said. “I’m on the side of allowing labs to prepare – that’s a no-brainer.”
Clinical laboratories have also begun developing their own tests from scratch. But researchers said they are moving cautiously because of a recent FDA rule that gives the agency greater oversight of lab-developed tests, lengthening the approval process. In an email to KFF Health News, FDA press secretary Janell Goodwin said enforcement of the rule will happen gradually.
However, Susan Van Meter, president of the American Clinical Laboratory Association, a trade group whose members include the nation’s largest commercial diagnostic labs, said companies need more clarity: “It slows things down because that this adds to the confusion about what is allowed. »
Creating tests for avian flu is already a risky bet, because demand is uncertain. It is unclear whether this outbreak in cattle will spark an epidemic or stop. Besides issues with the CDC and FDA, clinical labs are trying to determine whether health insurers or the government will pay for avian flu tests.
These wrinkles will eventually be smoothed out. Until then, the extremely small number of people tested, as well as the lack of testing on cattle, could draw criticism in other parts of the world.
“Think about our judgment of China’s transparency at the start of the COVID pandemic,” Nuzzo said. “The current situation undermines America’s position in the world.”
KFF Health News is a national newsroom that produces in-depth journalism on health issues and is one of the primary operating programs of KFF, an independent source of health policy research, polling and journalism. Learn more about KFF.