In the United States, veterinary diagnostic kits which are used to diagnose pathogens or a patient’s immune status are regulated as biologics by the United States Department of Agriculture – Animal and Plant Health Inspection Service (USDA-APHIS). Approval for these veterinary diagnostic kits are through the USDA’s Center for Veterinary Biologics (USDA-CVB). Examples of veterinary diagnostics which are regulated by the USDA-CVB are point-of-care diagnostics such as those to test for feline leukemia virus, canine parvovirus, canine heartworm, and other viruses, bacteria, parasites and veterinary pathogens. Veterinary reference laboratories are not necessarily subject to the same approval requirements as manufacturers of point-of-care diagnostic kits.
Veterinary Diagnostic Market Segments
The veterinary diagnostic market can be categorized several different ways, including:
- In house clinical chemistry and blood analysis equipment
- In house infectious disease immunodiagnostics (reagents, assays and test kits)
- Non-infectious disease diagnostic kits and equipment which can be used for analysis of hormones, immune function, and biomarkers.
- Molecular diagnostics kits such as PCR, or genetic analysis for specific hereditary diseases.
- Other testing reagents for use in histology (immuno-histochemistry, staining, etc.).
- Microbiology kits such as growth plates (agars, etc.)
- HPLC, MS, GC, and MALDI-TOF for proteomics and bioanalysis of biological samples (blood, etc.)
More information concerning the requirements for licensing a veterinary diagnostic can be found at the USDA-APHIS website (click here).
Veterinary Diagnostics Which Are Regulated as Diagnostic Kits: Certain veterinary diagnostic kits sold in the United States must obtain approval by the USDA-CVB, such as those used to diagnose pathogens like canine heartworm disease, canine parvovirus, feline leukemia virus, and other infectious diseases.
Veterinary Diagnostics Which May Be Exempt from Approval: Certain diagnostics used in veterinary medicine may not require an approval from the USDA-CVB. These may include biomarkers, immuno-histochemistry, proteomics, genetic testing, chemistry panels, CBCs, vitamin and mineral levels, cancer biomarkers, and serum electrophoresis. Pathogen testing conducted at a reference laboratory may also be exempt from USDA-CVB approval.