Alveo Technologies is developing a portable, rapid test for influenza A, B and avian H5. [Image courtesy of Alveo]
Such a test would enable physicians to quickly identify and report patients with A(H5) infections as the avian flu spreads across North American bird populations, dairy cows — and an increasing number of humans.
The A(H5N1) subtype is rare in humans but particularly dangerous, resulting in severe pneumonia and death in about 50% of cases, according to the CDC. However, that estimate may be high due to the likelihood that mild infections are not reported.
Human infections with H5N1 have been detected in at least 23 countries since 1997, and H5N1 outbreaks are ongoing at poultry farms, in dairy herds and among wild bird populations in Canada and the U.S.
Human case counts are also growing, and A(H5) virus is being detected in wastewater samples in California and — now for the first time — Hawaii. A previously healthy teenager in British Columbia is currently hospitalized in critical condition, marking Canada’s first locally acquired H5N1 infection.
Of the 46 confirmed human cases of A(H5) infections in the U.S. so far in 2024, none are believed to have been transmitted from human-to-human, and all but one have been traced to contact with sick cattle or poultry. The source of that one case remains unknown; the patient was hospitalized and recovered. Some of the most recent cases have been confirmed as H5N1 virus.
In June, the CDC sought proposals from the medtech industry to develop A(H5) diagnostic tests “to support response efforts in the event of an outbreak.”
“The primary challenge affecting this effort is the limited commercial availability and accessibility of diagnostic tests for Influenza A(H5),” the CDC said in its open call to industry. “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 have the capacity to handle a large number of 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.”
Alameda, California-based Alveo said it has already 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.”
The technology provides precise results in 30-45 minutes in the field, an Alveo representative told Medical Design & Outsourcing.
“As a multiplexed platform, the device can detect and differentiate between influenza A, B, and A/H5, from a single sample,” the company said in a statement shared with Medical Design & Outsourcing ahead of today’s announcement. “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.”
Alveo also plans to start shipping a molecular test in December for the avian influenza A subtypes most frequently identified in humans: H5, H7 and H9. (Learn more about these bird flu viruses from the CDC.)
In October, the company started shipping molecular, point-of-need tests for detecting avian flu in poultry in the EU.
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