Move comes following criticism from public health experts over the federal agency’s difficulties creating clinical laboratory tests for COVID-19
Amid the ongoing outbreak of the Highly Pathogenic Avian Influenza A(H5N1) bird flu virus, the US Centers for Disease Control and Prevention (CDC) announced on Sept. 13 that it is awarding contracts to five clinical laboratory companies to bolster testing capacity for “new and emerging pathogens,” including HPAI A(H5N1).
Citing Nirav Shah, MD, MPH, Senior Scholar, Clinical Excellence Research Center at Stanford University School of Medicine and co-chair of the Data and Surveillance Workgroup (DSW) at the CDC, the Associated Press (AP), reported that the agency will initially spend at least $5 million on the effort, with “plans to scale up to $118 million over the next five years if necessary.”
The five medical laboratory companies the CDC chose are:
- Aegis Sciences,
- ARUP Laboratories,
- Gingko Bioworks (NYSE: DNA),
- Labcorp (NYSE: LH), and,
- Quest Diagnostics (NYSE: DGX).
“Previously … CDC developed tests for emerging pathogens and then shared those tests with others, and then after that, commercial labs would develop their own tests,” Shah told CNN. “That process took time. Now with these new arrangements, commercial labs will be developing new tests for public health responses alongside CDC, not after CDC.”
In a news release announcing the contract, ARUP Laboratories also characterized the move as a shift for the agency.
“The new contract formalizes ARUP’s relationship with the CDC,” said Benjamin Bradley, MD, PhD, medical director of the ARUP Institute for Research and Innovation in Infectious Disease Genomic Technologies, High Consequence Pathogen Response, Virology, and Molecular Infectious Diseases. “We continue to expand our capabilities to address public health crises and are prepared to scale up testing for H5N1, or develop other tests quickly, should the need arise.”
“To be clear, we have no evidence so far that this [bird flu] virus can easily infect human beings or that it can spread between human beings easily in a sustained fashion,” Jennifer Nuzzo, DrPH (above), Director of the Pandemic Center and Professor of Epidemiology at Brown University School of Public Health, told CNN. “If it did have those abilities, we would be in a pandemic.” Clinical laboratory leaders will recall the challenges at the CDC as it developed its SARS-CoV-2 test early in the COVID-19 pandemic. (Photo copyright: Brown University.)
Missouri Case Raises Concerns
The first human infection of HPAI was reported in late March following a farmer’s “exposure to dairy cows presumably infected with bird flu,” the CDC stated in its June 3, 2024, bird flu Situation Summary. That followed confirmation by the USDA’s Animal and Plant Health Inspection Service (APHIS) of an HPAI outbreak in commercial poultry flocks in February 2022, and the CDC’s confirmation of the first known infections in dairy herds reported on March 25, 2024.
Concerns about the outbreak were heightened in September following news that a person in Missouri had been infected with the virus despite having no known contact with infected animals. CNN reported that it was the 14th human case in the US this year, but all previous cases were in farm workers known to be exposed to infected dairy cattle or poultry.
In a news release, the Missouri Department of Health and Senior Services (DHSS) revealed that the patient, who was not identified, was hospitalized on Aug. 22. This person had “underlying medical conditions,” DHSS reported, and has since recovered and was sent home. Both DHSS and the CDC conducted tests to determine that the virus was the H5 subtype, the news release states.
At present, the CDC states that the public health risk from the virus is low. However, public health experts are concerned that risks could rise as the weather gets cooler, creating opportunities for the virus to mutate “since both cows and other flu viruses will be on the move,” CNN reported.
Concerns over CDC Testing and FDA Oversight
In the months immediately following the first human case of the bird flu virus, Nuzzo was among several public health experts sounding an alarm about the country’s ability to ramp up testing in the face of new pathogens.
“We’re flying blind,” she told KFF Health News in June, due to an inability to track infections in farmworkers. At that time, tests had been distributed to approximately 100 public health labs, but Nuzzo and other experts noted that doctors typically order tests from commercial laboratories and universities.
“Pull us into the game. We’re stuck on the bench,” Alex Greninger MD, PhD, of the University of Washington Medicine Clinical Virology Laboratory, told KFF News.
KFF reported that one diagnostics company, Neelyx Labs, ran into obstacles as it tried to license the CDC’s bird flu test. Founder, CEO, and lead scientist Shyam Saladi, PhD, told KFF that the federal agency had promised to cooperate by facilitating a license and a “right to reference” CDC data when applying for FDA authorization but was slow to come through.
While acknowledging the need for testing accuracy, Greninger contended that the CDC was prioritizing caution over speed, as it did in the early days of the COVID-19 pandemic. “The CDC should be trying to open this up to labs with national reach and a good reputation,” he told KFF.
Another problem, KFF reported, related to the FDA’s new oversight of laboratory developed tests (LDTs), which is causing labs to move cautiously in developing their own tests.
“It’s slowing things down because it’s adding to the confusion about what is allowable,” American Clinical Laboratory Association (ACLA) President Susan Van Meter told KFF.
New Testing Playbook
Jennifer Nuzzo, DrPH (above), Director of the Pandemic Center and Professor of Epidemiology at the Brown University School of Public Health co-authored a June 2024 analysis in Health Affairs that called on the CDC to develop “a better testing playbook for biological emergencies.” The authors’ analysis cited earlier problems with the responses to the COVID-19 and mpox (formerly known as monkeypox) outbreaks.
If global surveillance networks have detected a novel pathogen, the authors advise, the US should gather information and “begin examining the existing testing landscape” within the first 48 hours.
Once the pathogen is detected in the US, they continued, FDA-authorized tests should be distributed to public health laboratories and the CDC’s Laboratory Response Network (LRN) laboratories within 48 hours.
Advocates of this approach suggest that within the first week diagnostics manufacturers should begin developing their own tests and the federal government should begin working with commercial labs. Then, within the first month, commercial laboratories should be using FDA-authorized tests to provide “high throughput capacity.”
This may be good advice. Experts in the clinical laboratory and healthcare professions believe there needs to be improvement in how novel tests are developed and made available as novel infectious agents are identified.
—Stephen Beale
Related Information:
CDC Adds Commercial Lab Contracts for Infectious Disease, Bird Flu Testing
ARUP Awarded CDC Contract for Bird Flu Test Development
Current H5N1 Bird Flu Situation in Dairy Cows
The US Is Entering a Riskier Season for Spread of H5N1 Bird Flu. Here’s Why Experts Are Worried
Wastewater Testing Specifically for Bird Flu Virus Will Scale Up Nationally in Coming Weeks
Two California Farmworkers Test Positive for Bird Flu
Avian Flu Spreading in California Raises Pandemic Threat for Humans
Bird Flu Is Spreading. Why Aren’t More People Getting Tested?
Why Fears of Human-to-Human Bird Flu Spread in Missouri Are Overblown
The United States Needs a Better Testing Playbook for Future Public Health Emergencies