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| Image created by Dr. Michael J. Miller |
Alveo Technologies, Inc. (Alveo), a leader in molecular sensing and diagnostics with its proprietary technology platform, today announced that it has demonstrated in silico that its rapid, hand held, point of need molecular diagnostic for avian influenza can detect the H5N1 variant based on sequences published from recent human infections in Colorado, as well as those found in infected cattle.
On July 15 and 16, GISAID (the Global Initiative on Sharing All Influenza Data database) released the genetic sequence of the H5N1 viruses that recently infected one of the dairy farm workers in Colorado. Notably, GISAID said that a "mammalian adaptation marker (E627K) was noted in one of the farm workers." The method of transmission among cattle remains unknown, but the implications are concerning. It is possible that cattle are shedding a mammalian-adapted virus that could be reintroduced to commercial poultry, or that selection pressures are driving the virus towards mammalian adaptation. In either case, the ongoing outbreak among cattle increases the risk that H5N1 will gain the ability to spread efficiently among humans.
The UK Health Security Agency released a report in May that stated, "The baseline risk of influenza A(H5N1) evolving to cause human transmission before the current cattle outbreak was previously considered to be a remote chance (0-5%). There is consensus that this risk has now increased. However, with current limited information we cannot resolve the risk further and it may fall at highly unlikely (10-20%) or unlikely (25-35%)."
Testing is a critical component in the fight against emerging infectious diseases, and recent outbreaks highlight the urgent need to increase testing capacity for avian influenza for both animals and humans. Alveo conducted in silico analysis using their previously developed Avian influenza A subtype H5 LAMP designs on recently reported human and bovine sequences obtained from GISAID. Results show that Alveo H5 designs are concordant with all 12 reported sequences of emerging influenza A subtype H5 sequences. This suggests that the LAMP Avian influenza assay is capable of detecting all 12 reported sequences belonging to clade 4.3.4.4b, H5N1, including the variants found in humans.
Alveo expects the Flockscreen LAMP Avian Influenza Molecular Test for poultry, the first diagnostic of its kind that can test both cloacal and oropharyngeal samples, and which the company developed with numerous partners, to begin shipping to Europe and the Middle East in the third quarter of 2024 once validation and verification activities have concluded with the relevant regulatory bodies. The company is now actively working to validate avian influenza diagnostics for both human and bovine use cases.
"Avian influenza has already caused enormous damage to the poultry industry and has devastated populations of wild birds," said Shaun Holt, CEO of Alveo Technologies. "We still have time to prevent H5N1 from evolving further into a dangerous virus that spreads efficiently among people, but to do so, we need fast, precision diagnostics for both humans and animals. Alveo's portable and rugged, rapid molecular testing platform can fill this gap, providing accurate results to supplement limited lab resources and capacity. Given the urgent need, we have been relentless with respect to the time and resources we've devoted to developing our H5N1 test; we've also partnered with industry leaders which allowed for access to countless actual field samples of the virus to confirm sensitivity and specificity for the real world. These initial results, indicating we can detect the virus in cattle and humans in addition to poultry, is confirmation of our rigor in the product development process and is very much aligned with our strategic positioning at the intersection of human, animal and food health."
About Alveo
Alveo is the first company to make molecular detection and diagnostics universally accessible – on the farm, in the field, in the clinic, or in the manufacturing plant – helping prevent or significantly limit the destructive impact of viruses, fungi, bacteria, and other pathogens by detecting earlier at the Point of Need™. Alveo's rugged and portable, multiplex-capable diagnostic platform employs a patented method of direct electrical sensing of nucleic acid amplification to provide affordable, rapid, and accurate results. By enabling early pathogen detection, Alveo helps manage global health, food security, and supply chain resiliency by providing actionable insights at lightspeed.