Home 5 Clinical Diagnostics Insider 5 Labcorp, Quest, and ARUP Develop Bird Flu Tests with CDC Help

Labcorp, Quest, and ARUP Develop Bird Flu Tests with CDC Help

by | Jan 28, 2025 | Clinical Diagnostics Insider, Testing Trends-dtet

The assays were developed with the CDC as part of recent trend of public-private partnerships to improve pandemic preparedness

Three laboratories have quickly developed and released tests for H5N1 bird flu in conjunction with the Centers for Disease Control and Prevention (CDC). These partnerships reflect a recent trend of increased public-private partnerships in the laboratory industry to boost pandemic preparedness.

The tests were developed and released by Labcorp, Quest Diagnostics, and ARUP Laboratories, according to the CDC and statements issued by the companies in recent weeks. Contracts were signed with all three companies last September to develop the tests, with the CDC offering guidance and reagents to assist in the validation of the assays.1 The values of the contracts or their specific terms have not been disclosed.

H5N1: pandemic concerns

The H5N1 virus has become an issue of increasing concern in the United States and elsewhere, particularly given that the imprint of the COVID-19 pandemic remains fresh in people’s minds. Bird flu is a variation of the H5 virus, which in turn is a subtype of the influenza A virus. Although H5N1 remains mostly confined to birds and livestock, cases of it being transmitted to humans have been documented in recent months. Earlier this month, officials announced the first American death from H5N1 in Louisiana. According to the World Health Organization, there have been at least 950 confirmed infections of humans from bird flu since 2003. About half of those infected eventually died from the virus.2

The CDC’s role in H5N1 test development

Since early 2023, the CDC has offered access to the design of its test for the H5 virus to both labs and equipment manufacturers to speed up the process of developing a nationwide testing infrastructure.

“CDC’s extensive collaboration with commercial laboratories has strengthened the national testing infrastructure and ensured broader availability of diagnostics for H5N1 bird flu,” says agency spokesperson Jasmine Reed.

Prior to the development of the tests by the three labs, specimens suspected of containing H5N1 had to be tested at CDC or state-sanctioned public laboratories.

Closer relationships between the agency and commercial labs should mean an improved pandemic response, according to a Quest representative.

“Emerging diseases like avian influenza require close coordination between the commercial laboratory industry and the CDC and other federal and state agencies to monitor and mobilize a rapid response,” said Quest senior vice president and chief medical officer Yuri Fesko, MD, in a recent statement.3

The three commercial H5N1 tests

The assays themselves are laboratory-developed tests that have been designed for a fairly rapid response.

According to Benjamin Bradley, MD, medical director for ARUP’s research institute, the ARUP test can be turned around within one to three days of receipt. All tests are processed by ARUP’s laboratory in Salt Lake City, UT. Tests can be handled from all 50 states, although ARUP is still waiting on regulatory approval from New York State, which has a unique laboratory test regulatory regime.

Bradley indicates that the initial interest in the test is expected to be low, particularly if clinicians follow CDC guidelines on which patients should be tested.

“However, given the significant public health risk posed by novel influenza viruses and the speed at which infections could spread across the US, we made the decision to preemptively provide an H5 test and will scale capacity according to customer need,” he says.

Bradley adds that the CDC has been extremely cooperative in developing the new assays. “The CDC has provided the laboratory community with technical input on assay design, and we have even received positive control material to assist with our assay development,” he says.

Labcorp’s test has a one- to two-day turnaround time, a company spokesperson said in an email.

Quest’s assay, which was introduced late last year, is described as an immediate response molecular test, although the testing will be performed at its laboratory in San Juan Capistrano, CA. The assay does not test for any seasonal influenza A subtypes, influenza B, or any viruses that attack the respiratory system.3

Quest executive scientific director Elizabeth Marlowe says that turnaround times for the test are currently between one and three days, although that can change based on test volumes.

“Fortunately, testing demand remains at a minimum,” she says.

How much do the H5N1 tests cost?

The three companies add that the retail price for the test might differ significantly.

“The cost of the H5 bird flu test can vary based on several factors,” a Labcorp spokesperson says. “We recommend consulting with insurance carriers to learn about coverage and out-of-pocket costs, if any.” 

Other partnerships with the CDC

CDC spokesperson Reed notes that the agency has signed contracts with two other companies—Hologic and Alveo—to further development of bird flu testing. “H5 subtyping assay and reagent development by these companies is currently underway,” she says.

In addition to receiving the contract to develop the bird flu test, the CDC also inked a pact with Quest to develop a test to detect the Oropouche virus.3 That virus is transmitted by mosquitoes and midges and can lead to meningoencephalitis—a life-threatening inflammation of the brain and surrounding tissues. Oropouche is often misdiagnosed as malaria or dengue fever.4

“While the threat of avian influenza and Oropouche virus to the public remains low, we applaud CDC for its forward-thinking approach to ensuring commercial laboratories are prepared to quickly mobilize should a serious threat to human health emerge,” Marlowe said in a statement announcing the contract.3 

Pharus releases LDT for pancreatic cancer

In other recent diagnostics news, Los Angeles-based Pharus Diagnostics has released a laboratory-developed test intended to aid in the detection of pancreatic cancer, one of the deadliest forms of the disease.5

The test, called OncoSweep Pancreas Spotlight, uses blood samples, next-generation sequencing, and machine learning to detect pancreatic ductal adenocarcinoma in patients who have an elevated risk for the disease. The test has been refined through work with the City of Hope cancer treatment and research center. Testing will be conducted at the PacificDx laboratory in Irvine, CA.

“An accurate early detection tool can significantly improve outcomes for people with [pancreatic cancer], particularly when surgical intervention remains a viable option,” said Pharus chairman Bowei Lee in a statement.5

The five-year survival rate for pancreatic cancer is less than 15 percent, according to data from the American Cancer Society.6 That’s primarily because the disease has virtually no symptoms until it enters its late stages.

References:

  1. https://www.cdc.gov/bird-flu/spotlights/h5n1-response-01172025.html
  2. https://apnews.com/article/bird-flu-death-louisiana-82e4d00876e62cb2b13bb621826c84f9
  3. https://newsroom.questdiagnostics.com/2024-10-23-Quest-Diagnostics-Awarded-CDC-Contracts-for-H5-Avian-Influenza-and-Oropouche-Virus-Test-Development
  4. https://www.cdc.gov/oropouche/hcp/clinical-overview/index.html
  5. https://www.prnewswire.com/news-releases/pharus-diagnostics-llc-announces-validation-of-a-laboratory-developed-test-for-early-pancreatic-cancer-detection-302333680.html
  6. https://www.cancer.org/cancer/types/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html

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