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Zomedica Announces Achievement of Product Development Milestones on its TRUFORMA™ Point-of-Care Diagnostic Platform
ANN ARBOR, Mich., May 21, 2019 (GLOBE NEWSWIRE) -- Zomedica Pharmaceuticals
Corp. (NYSE American: ZOM) (TSX-V: ZOM), a veterinary
diagnostic and pharmaceutical company, today announced that
TRUFORMA™, its point-of-care biosensor platform, recently
achieved two important product development milestones.
The TRUFORMA™ platform, formerly designated ZM-024, is a table-top instrument that will use disposable assay cartridges to test a range of samples including whole blood, serum, and plasma. The platform uses differentiated Bulk Acoustic Wave (BAW) sensor technology to provide a non-optical and fluorescence-free detection system for use at the point-of-care.
The milestones achieved are beta finalization of the
instrument design and the completion of feasibility testing
of the TRUFORMA™ platform’s first assays. Completion of the
beta design milestone allows a transition to commercial
production for the instrument.
The TRUFORMA™ initial assay cartridge candidates include total thyroxine (total T4), free thyroxine (fT4), thyroid stimulating hormone (TSH), cortisol, and endogenous adrenocorticotropic hormone (ACTH) for canine and feline patients.
The standard of care for total T4, fT4, TSH, and cortisol is reference lab immunoassays generally run on expensive laboratory equipment. Utilizing the FDA Center for Veterinary Medicine recommendations for Bioanalytical Method Validation, Zomedica has demonstrated that the initial TRUFORMA™ assays attained acceptable ranges for precision and accuracy.
Feasibility results for the initial TRUFORMA™ assays achieved statistically significant correlation with corresponding standard of care reference lab tests. These results demonstrate these initial assays are satisfying Zomedica’s target product specification for correlation greater than 0.95 and for dynamic range, which depending on the assay, are as low as 9 pg/mL and greater than 500 ng/mL. Time to result during this feasibility testing averaged less than 15 minutes utilizing canine and feline serum samples.
“We believe these feasibility results demonstrate that we will be able to develop TRUFORMA™ assays that will meet or exceed the performance capabilities of existing reference laboratory tests, which may result in equivalent or better diagnostic sensitivity and specificity,” Stephanie Morley, DVM, Chief Operating Officer and Vice President of Product Development, Zomedica. “We are excited by these early results and look forward to continuing our development of the TRUFORMA™ platform to enable the testing of these assays, of which fT4, feline TSH and ACTH are novel to the point-of-care.”
“Based on the results obtained in our feasibility testing, we believe TRUFORMA™ assays have the potential to help clinicians make informed decisions about thyroid and adrenal issues during a patient’s visit to the clinic, which we believe will result in earlier treatment and enhanced treatment compliance,” said Bruk Herbst, Chief Commercial Officer, Zomedica.
Assuming the successful completion of the remaining development milestones, Zomedica intends to commence marketing the TRUFORMA™ platform with the initial assays in the first quarter of 2020. Zomedica expects to develop additional assays for the TRUFORMA™ platform, including a non-infectious gastrointestinal panel, following the completion of the initial assays.
TRUFORMA™ is an investigational device, not currently available for sale and limited to investigational use only.
Based 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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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.
The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.
Investor Relations Contact:
Shameze Rampertab, CPA, CA
PCG Advisory Group
Kirin Smith, COO
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