The Centers for Disease Control and Prevention has signed an agreement with Alveo Technologies to develop a handheld avian flu molecular diagnostic for humans that returns results in 30-45 minutes and is accurate on par with PCR tests.
No rapid tests exist in the U.S. that specifically test for the H5N1 virus.
Avian flu tests must be conducted at labs, and it takes days or weeks to return results.
In the event of an H5N1 outbreak among humans, these labs would become huge bottlenecks, slowing test results. According to experts, the world urgently needs precise, rapid tests for H5N1 to prepare for the worst-case scenario.
The CDC agreement is with Alveo, a leader in molecular sensing and diagnostics with its proprietary IntelliSense™ molecular detection technology with a competitive basis to develop a rapid, molecular, point-of-need diagnostic to detect and differentiate between Influenza A + B and A/H5 in humans.
In June, the CDC issued an open call for innovative solutions to meet the agency's diagnostic test development needs for avian influenza. The virus has been confirmed in birds, cattle, poultry, and people in several countries including the United States and Canada, heightening the urgency to support advanced preparedness if human-to-human transmission occurs.
According to the CDC's open call to industry that requested innovative solutions from diagnostic technology companies, "currently, the only public health laboratories in the U.S. equipped to test for this virus are CDC and state and jurisdictional public health laboratories with access to the CDC A(H5) assay. This poses a significant problem as these laboratories may not be able to handle many cases in the event of an H5 epidemic or pandemic. This could result in delays in diagnosing and treating individuals, leading to the further spread of the virus."
Alveo has developed a portable, easy-to-use molecular detection platform that utilizes isothermal nucleic acid amplification technology (NAAT) and provides fast and qualitative results at the point of need. As a multiplexed platform, the device can detect and differentiate between influenza A, B, and A/H5 from a single sample. Additionally, the platform can automatically deliver accurate, real-time results via a secure cloud-based portal for analysis and reporting.
As a result, Alveo's solution can facilitate early detection and intervention, enhance public health surveillance, and improve the overall response to seasonal influenza and potential avian influenza A/H5 outbreaks. By decentralizing testing capabilities, Alveo will increase access to critical diagnostics, reduce the burden on centralized laboratories, and bolster pandemic preparedness and response efforts.
The CDC agreement to develop avian influenza tests is just part of Alveo's broad strategy to develop diagnostics to manage global health, food security, and supply chain resiliency. Next month, Alveo will begin shipping a molecular test for all relevant subtypes of avian influenza (Type A, H5, H7, H9) in poultry.
The CDC agreement and development goals support a natural expansion of Alveo's product line, given its synergies with assays already developed. "It is gratifying to be selected and enter this agreement to accelerate the development of our point-of-need diagnostic solutions for H5," said Shaun Holt, CEO at Alveo. "We are proud to work with CDC to be a part of a national preparedness effort by enabling timely detection and response where it matters most - at the front lines of care."
Alveo Technologies is the first company to make molecular detection and diagnostics.