Zomedica Pharmaceuticals Corp. (NYSE American: ZOM) (TSX-V: ZOM), a veterinary diagnostic and pharmaceutical company, today announced additional development progress on two assays for its TRUFORMA™ point-of-care biosensor platform. Development of what Zomedica believes is the first-ever point-of-care assay for canine endogenous adrenocorticotropic hormone(eACTH) and an assay for feline thyroid stimulating hormone (feline TSH) demonstrates the potential of TRUFORMA™. Diagnostic research efforts are being focused on additional assay development for TRUFORMA™ including non-infectious gastrointestinal, diabetes, and renal assays.
Zomedica’s continued development of TRUFORMA™ assays is intended to allow veterinarians to provide full diagnostic testing for adrenal and thyroid disease in both canine and feline patients in a single clinic visit.
“To our knowledge, no point-of-care device has the sensitivity and testing performance required to detect canine eACTH and feline TSH,” Dr.Stephanie Morley, Chief Operations Officer and Vice President Product Development stated. “We believe our device will satisfy the unmet needs of our veterinary customers seeking solutions to provide a rapid diagnosis for dogs and cats with complex and debilitating adrenal and thyroid disease. WithTRUFORMA™, we believe that veterinarians will no longer have to wait days for reference lab results and will be able to make clinical decisions in a single office visit.”
Current methods for diagnosing the two most common canine adrenal diseases, Cushing’s1 and Addison’s, may require multiple visits, potential hospitalization of dogs for injections and multiple blood draws over time which is expensive, stresses patients, and requires significant veterinary staff time. The availability of canine eACTH at point-of-care has the potential to change the way veterinarians manage two chronic and potentially life-threatening diseases in dogs by providing accurate results more quickly and at a lower cost. We have achieved preliminary performance data for TRUFORMA™ canine eACTH with analytical sensitivity (< 9 pg/mL) and expect that the accuracy and time to result will be 16 minutes or less.
Hyperthyroidism is a common and chronic metabolic disorder in cats, requiring life-long treatment. It is estimated that over 10 percent of all senior cats will develop hyperthyroidism2. Despite the high prevalence of the disorder, we do not believe that a specific feline TSH assay is commercially available, either at reference labs or at the veterinary clinic. Instead, veterinarians are forced to rely on a specific canine TSH assay performed at a reference lab that does not offer the analytical sensitivity to accurately detect low levels of TSH in felines. Preliminary assay performance data generated by Zomedica indicates that the TRUFORMA™ feline TSH assay has the ability to diagnose hyperthyroid cats with an analytical sensitivity as low as 0.01 ng/mL. These preliminary results satisfies Zomedica’s target product specification for correlation greater than 0.95 and for a dynamic range of 0.03 ng/mL to > 10 ng/mL. Zomedica expects time to result will be 15 minutes or less.
Canine and feline adrenal and thyroid diseases are chronic metabolic disorders. Veterinarians often measure multiple hormones to better understand disease progression and monitor response to therapy. If Zomedica is successful in its development efforts, TRUFORMA™ will allow veterinarians to measure canine and feline total T4 and TSH, as well as measure canine free T4, eACTH, and cortisol to diagnose and manage the care of canines and felines suffering from hyperadrenocorticism, hypoadrenocorticism, hyperthyroidism, and hypothyroidism at the point of care.
Assuming the successful completion of verification and validation, Zomedica expects to commence marketing the TRUFORMA™ platform, including the canine eACTH and feline TSH assays, in first quarter of 2020.
TRUFORMA™ is an investigational device, not currently available for sale and is currently limited to investigational use only.
About ZomedicaBased in Ann Arbor, Michigan, Zomedica (NYSE American: ZOM) (TSX-V: ZOM) is a veterinary diagnostic and pharmaceutical company creating products for companion animals (canine, feline and equine) by focusing on the unmet needs of clinical veterinarians. Zomedica’s product portfolio will include novel diagnostics and innovative therapeutics that emphasize patient health and practice health. With a team that includes clinical veterinary professionals, it is Zomedica’s mission to give veterinarians the opportunity to lower costs, increase productivity, and grow revenue while better serving the animals in their care. For more information, visit www.ZOMEDICA.com
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