Avian flu is a death sentence for birds. The outbreak of 2022 continues and is now close to claiming 100 million birds nationwide.

Michigan has gotten the brunt of it in 2024, with more than 6 million birds having to be depopulated, while the disease has now infected dairy operations and humans.

The longer a flock is infected and the more cycles between birds and cattle, there is concern the virus may mutate — eventually enabling easy transmission between humans, potentially creating a pandemic reminiscent of COVID-19. The virus has already crossed to infect four humans in the U.S. and about 30 different animals.

You can’t control the unknown, which is why the California-based company Alveo Technologies is preparing to launch the availability of an easy, quick, hand-held molecular test for all highly pathogenic avian influenza strains, including H5N1. It is designed to be rugged and reusable for on-farm use, says Shaun Holt, CEO of Alveo.

“It’s cost-effective, easy to use and you get results in around 30 minutes at a fraction of the cost of today’s testing methods, which are essentially becoming obsolete given the virus has mutated over time,” he says. “Catching it early could prevent it from potentially spreading within the farm to other houses and beyond.”

Works in conjunction with vaccination

While rapid detection leads to earlier insight into pathogen spread and supports efforts to secure global health and prevent future pandemics, there’s a benefit to having a quick test for vaccinated birds.

Disease, or the potential for disease, can have international marketing implications.

In October, the U.S. blocked the importation of French poultry in response to the start of mass avian influenza vaccination of ducks. Vaccinated poultry can still transmit the virus, Holt says. Because they may show no symptoms, and because there’s a lack of rapid, accurate molecular testing, there’s no way to know whether the virus is present in a flock without the combination of testing and vaccination.

Currently, avian influenza testing typically takes one of two forms: lab-based PCR or lateral flow tests (LFTs), commonly known as antigen tests. PCR tests are accurate, but they require sending samples to central or nationally approved laboratories for testing.

Results can take days or even weeks to process depending on lab capacity and criticality, Holt says, which delays decision-making at the farm level, increases the risk of infection from one flock or farm to another and extends human exposure time. Lateral flow tests produce rapid results, but they are also not nearly as accurate as PCR and generally lack multiplexing capability beyond a strain or two, he says.

30-MINUTE RESULTS: The tests use tracheal or cloacal fluid samples inserted into a a cartridge and then flipped into the analyzer, which is a bit thicker than an iPhone.

Testing provides a two-pronged approach as vaccination is only 80% to 90% effective. “Alveo tests are well above 90% sensitivity and specificity, nearly in line with PCR testing,” he says.

“The old way of testing — reactive testing and culling — is not going to work in terms of preventing spillover risk going forward [humans and other animals], and it's not working either in terms of containment,” says Holt, who notes his company has been developing the test for two years.

“Our plan is to launch in Q3 of this year, first in the EU and the Middle East,” he says. “It’s a much faster path to market for us, and they have poultry vaccination programs in place with specific funding devoted to the testing component.”

Alveo leadership met with USDA in May to begin the process of commercialization. “A diagnostic test for livestock generally takes roughly two years following the standard process, which we have started in earnest,” he says of the U.S. regulatory framework. “Our intent in meeting with USDA was to understand what that path looks like, because we are a U.S.-based company and want to support the U.S. poultry industry.”

How it works

The tests, which use either tracheal or cloacal sample types, are less than $100 for one test, and validation studies are being conducted to support pooling of five to 10 birds in a single test. Fluids are transferred into a cartridge and then inserted into the analyzer, which is a bit thicker than a mobile phone.

“The software walks you through step by step,” Holt says. Alveo’s platform also provides geo-tagged results that are uploaded to the cloud to give a real-time view of national outbreaks and inform response.

“It's a fraction of the cost of what the government — ultimately taxpayers — incurs to test in labs,” he says. “They've got a lot of people and specialized equipment. The logistics alone, of sampling, handling and shipping, is likely more than what the Alveo test will cost.”

Alveo intends to deploy its molecular testing at the point of need across a broad spectrum of markets and applications, including crop protection, livestock, companion pets, bioprocessing and human health applications.