USDA Approves Bionote’s Canine Heartworm Test Kit – Q2 2024


The global company Bionote, specializing in bio-content and animal diagnostics, announced on the 13th of May that its product, the 'Rapid CHW Ag 2.0' antigen diagnostic kit for canine heartworm, has obtained approval for sale from the United States Department of Agriculture (USDA).  


Consequently, the product can be sold and distributed within the United States through Bionote's U.S. subsidiary, Bionote USA.


Canine heartworm disease, transmitted primarily by mosquitoes, is a representative parasitic infectious disease in dogs. Heartworms, which primarily parasitize the pulmonary arteries, can lead to severe cardiovascular diseases and, in severe cases, death.


It takes 6 to 7 months for the microfilariae transmitted by mosquitoes to grow into adult worms inside the dog's body. Clinical symptoms often do not immediately appear, which can lead to delayed diagnosis.


Therefore, the American Heartworm Society (AHS) recommends monthly heartworm prevention and testing for heartworm infection at least once a year.


Bionote's Canine Heartworm Antigen diagnostic kit can detect even a very small number of female worms (1 to 5 worms) and provides test results within 10 minutes.


The newly approved 'Rapid CHW Ag 2.0' product is an upgraded version with a more compact design, making it even more suitable for on-site testing compared to the previously sold 'Rapid CHW Ag 1.0'.


A Bionote representative stated, "According to research conducted at the University of Florida, the product has demonstrated a sensitivity and specificity of over 100% compared to the gold standard test, proving its high accuracy." They further stated, "The United States is a large market that accounts for over 40% of the global animal diagnostic testing market. We will continue to expand our presence in the U.S. market through further USDA product registrations, maximizing the sales force of our U.S. subsidiary, and collaborating with partners.