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Zomedica Commences TRUFORMA Diagnostic Verification Study

Friday, November 22, 2019   (0 Comments)
Posted by: Alisha Brown
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ANN ARBOR, Mich., Thursday, October 31, 2019 (GLOBE NEWSWIRE) – Zomedica Pharmaceuticals Corp. (NYSE American: ZOM) (TSX-V: ZOM), a veterinary diagnostic and pharmaceutical company, announced today that it has commenced the final verification study of the first five assays designed for use with its point-of-care diagnostic biosensor platform, TRUFORMA™.

The verification study is evaluating the utility of the first five thyroid and adrenal assays intended for use with the TRUFORMA™ platform. The initial three thyroid assays are: canine and feline total T4 (thyroxine), canine free T4, and canine and feline TSH (thyroid stimulating hormone). The verification study also is evaluating two adrenal assays: canine cortisol and canine eACTH (endogenous adrenocorticotropic hormone). The verification study will evaluate 65 blood samples per assay, or 325 total samples. Zomedica has 216 samples ready for evaluation, 40% are feline and 60% canine. Zomedica expects that the verification study will be completed in December. Assuming the final verification study concludes successfully and following successful completion of a final validation study, Zomedica expects to commence commercialization activities of the TRUFORMA™ platform in Q1 2020.

The TRUFORMA™ platform uses Bulk Acoustic Wave (BAW) technology to provide a non-optical and fluorescence-free detection system for use at the point-of-care. BAW technology, also used in cell phones and the world’s most advanced radar and communications systems, is an extremely reliable and precise technology. However, Zomedica believes that the TRUFORMA™ platform represents the first use of BAW technology in disorder and disease-state diagnostics.

Zomedica expects that the verification study will demonstrate that the performance of the TRUFORMA™ platform can deliver sensitivity and specificity equal to or greater than reference lab tests, and with what Zomedica believes is the first-ever point-of-care eACTH assay validated for use in dogs and feline TSH assay validated for use in cats.

“As a clinician, I believe that confidence in a diagnosis is a key to making definitive treatment recommendations, leading to better outcomes for patients, and better experiences for pet owners,” said Dr. Stephanie Morley, DVM, Zomedica’s president. “Our expectation is that TRUFORMA™ will enable veterinarians the solutions to provide a rapid diagnosis for cats and dogs with complex and debilitating adrenal and thyroid disease, eliminating multi-day wait periods for reference lab results and allowing for confident clinical decisions in a single office visit.”

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