ANN ARBOR, Mich., Aug. 07, 2019 (GLOBE NEWSWIRE) -- Zomedica Pharmaceuticals Corp. (NYSE American: ZOM) (ZOM.V), 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. With TRUFORMA™, 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.
Based in Ann Arbor, Michigan, Zomedica (NYSE American: ZOM) (ZOM.V) 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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Except for statements of historical fact, this news release contains certain "forward-looking information" within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate" and other similar words, or statements that certain events or conditions "may" or "will" occur. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.
Forward-looking information is based on the opinions and estimates of management at the date the statements are made and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: risks related to our ability to successfully complete the development of the TRUFORMA™ platform, uncertainty regarding our ability to develop assays that provide results as reliable as those provided by existing reference laboratory equipment, risks related to the marketing the TRUFORMA™ platform, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work and pilot and pivotal studies, uncertainty as to the likelihood and timing of regulatory approvals, availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to future clinical trials, regulatory approvals, safety and efficacy of our products, the use of our product, intellectual property protection and the other risk factors disclosed in our filings with the Securities and Exchange Commission. Readers are cautioned that this list of risk factors should not be construed as exhaustive.
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Investor Relations Contact:
Shameze Rampertab, CPA, CA
PCG Advisory Group
Kirin Smith, COO
- de Bruin C, Meij BP, Kooistra HS, Hanson JM, Lamberts SW, Hofland LJ. Horm Res. Cushing's disease in dogs and humans. January 2009.
- Peterson, M. J Feline Med Surg. Hyperthyroidism in cats: what's causing this epidemic of thyroid disease and can we prevent it? November 2014.