ALAMEDA, Calif. — Alveo Technologies Inc. has announced that it has successfully fulfilled all objectives outlined in both its existing and follow-on expanded agreement with the U.S Centers for Disease Control and Prevention (CDC) to further advance its rapid, molecular, point of care diagnostic, be.well® to detect and differentiate between seasonal Influenzas A and B, as well as Influenza A(H5), a subtype of Influenza A commonly associated with highly pathogenic avian influenza, in humans.
The core milestones, including assay development, software integration and manufacturing scale-up, were achieved on schedule and to specification, the company said.
“This accomplishment exemplifies the power of proactive, cross-functional collaboration and public-private partnerships,” Shaun Holt, Alveo CEO, said. “Our work under this agreement has not only met its defined goals but has also built the infrastructure and readiness necessary to support rapid response during future outbreaks. These achievements reflect our ongoing commitment to strengthen the nation’s pandemic preparedness and address potential emerging infectious disease threats with speed, accuracy and innovation.”
Alveo’s be.well® platform is a portable, rapid molecular testing device made possible by IntelliSense™, a patented method of direct electrical sensing of nucleic acid amplification with everything needed for the test included in a single kit, the company said, adding that the palm-sized molecular analyzer allows users to test at the Point of Need – on the farm, in the field, or in the clinic – for different pathogens. Collected samples are transferred to a cartridge, inserted into the analyzer, and accurate results are ready in 45 minutes or less via a mobile app. No transportation, logistics or central lab is needed. Through the Alveo Vista portal, the raw data and analytics from these results can be automatically geotagged, uploaded to the cloud in a private and secure environment, and then exported for regulatory agencies and public health officials to have actionable insights at light speed. Alveo’s platform has broad industry applications as it serves human, animal and environmental health, making it a truly novel One Health solution for global testing, monitoring and data reporting of pathogens.
The company’s Alveo Sense Poultry Avian Influenza Test is already in use in several countries in the European Union, Middle East and Asia testing for all relevant strains of highly pathogenic avian influenza in poultry.
After completing the CDC’s original scope of work in January 2025, which focused on validating nasal samples, Alveo demonstrated feasibility for using conjunctival samples (from the mucous membrane inside the eyelid) in order to get a better understanding of common symptoms associated with Influenzas A and B, as well as Influenza A(H5).
Alveo adds that this is an important capability, as signs and symptoms in most confirmed human cases of avian flu in the U.S. include conjunctivitis, commonly known as pink eye. Alveo’s verification studies, conducted using its be.well platform, demonstrated performance equivalence and sensitivity to that of nasal samples tested using polymerase chain reaction (PCR), confirming the assay’s adaptability and robustness across specimen types.
“Scientists are still learning how the H5N1 avian influenza virus affects humans,” Holt added. “The versatility of our diagnostic testing, monitoring and reporting ecosystem to adapt to new information as it becomes available is extremely beneficial to the CDC. Our platform enables the rapid, accurate detection of Influenza A(H5) presenting as conjunctivitis without having to send a sample to a lab. Our solution is designed to facilitate early treatment and intervention, enhance public health surveillance, and improve the overall response to seasonal influenza and potential Influenza A(H5) outbreaks.”
