Zomedica Pharmaceuticals Corp., a veterinary diagnostic company, announced that it has completed the verification of TRUFORMA™, its point-of-care diagnostic biosensor platform, and the first assay, Canine total T4 thyroxine.
ANN ARBOR, Mich., April 21, 2020 (GLOBE NEWSWIRE) -- Zomedica Pharmaceuticals Corp. (NYSE American: ZOM) (“Zomedica” or the “Company”), a veterinary diagnostic company, announced today that it has completed the verification of TRUFORMA™, its point-of-care diagnostic biosensor platform, and the first assay, Canine total T4 (“tT4”) thyroxine.
In partnership with Qorvo Biotechnologies, LLC (“Qorvo”), a wholly-owned subsidiary of Qorvo, Inc., Zomedica is developing what both companies believe may be a first-of-its-kind, complete thyroid and adrenal detection platform that uses proprietary, non-optical Bulk Acoustic Wave (“BAW”) sensor technology. The BAW sensor is a proven semiconductor technology used in telecommunications and aerospace markets. The Company believes that BAW technology has the potential to improve veterinary diagnostics by delivering reference laboratory accuracy and test performance to the veterinary clinic at the point-of-care.
TRUFORMA™ platform verification is a critical milestone on the path to transfer to commercial scale manufacturing. Verification confirms the achievement of instrument design specifications, which follows FDA Medical Device design control guidelines, to ensure the product was built correctly. Instrument verification means key performance aspects have been met, such as: hundreds of electrical and mechanical hardware design specifications, operation capabilities under a wide variety of operating conditions (temperature, humidity, noise and surface), and the safety specifications and compliance of a diagnostic device under Underwriters Laboratories guidelines. In addition to verification of the equipment, platform verification also achieves human diagnostic software requirements and standards, such as user workflow, user interface, and core controlling software.
The TRUFORMA™ diagnostic device and platform, which is smaller than a desktop printer, is anticipated to provide highly sensitive, species-specific initial assays for the diagnosis of thyroid disease in dogs and cats, and adrenal disease in dogs. Minimal clinic staff training is required to centrifuge the blood sample and dispense a small amount of serum (~100 μL) into the disposable assay cartridges which come preloaded with reagents.
The first assay verification completed on the TRUFORMA™ platform, conducted on-site at Qorvo in two different facilities on 56 samples across 700 cartridges, is the Canine tT4 assay. Verification data demonstrated promising correlation and dynamic range results for Canine tT4 compared to the current industry standard Canine tT4 reference lab assay. If the same sample is tested on two different types of machines and achieves exactly the same results the correlation would be R=1. TRUFORMA™ achieved statistically significant high correlation of R > 0.95 to the Siemens IMMULITE® Canine tT4 assay (P value < 0.0001). Dynamic range is the functional range of a test over which the concentrations of an analyte can be measured with acceptable accuracy and precision. The TRUFORMA™ dynamic range is 0.45 - >30 µg/dL (vs. Siemens Immulite® Canine T4 dynamic range of 0.5 – 15 ug/dL) which should permit the measurement of samples with very low tT4 levels (hypothyroid) and very high tT4 (hyperthyroid) levels.
Under the Company’s exclusive development and supply agreement with Qorvo, the achievement of this milestone will require the Company to make a $3 million payment to Qorvo.
The TRUFORMA™ tT4 assay will also be subjected to verification testing for feline applications. Additional verification activities are ongoing for the remaining four go-to-market thyroid and adrenal TRUFORMA™ assays. The assays in verification testing are: Canine Free T4 and Canine and Feline TSH (thyroid stimulating hormone). The initial two adrenal assays are: Canine Cortisol and Canine endogenous ACTH (endogenous adrenocorticotropic hormone).
Upon completion of verification testing, the Company expects to commence the validation of each assay and to initiate a parallel pilot program focused on optimizing the customer experience. Assuming successful completion of this verification and development work, Zomedica intends to commence commercialization of all five initial assays in select strategic markets.
As previously reported by the Company, the novel coronavirus, or COVID-19, pandemic has impacted the Company’s expected timing for the completion of the development and the initiation of the commercialization of the TRUFORMA™ platform and the five initial assays. Once our development partner, validation participants and potential customers are able to return to normal operating procedures, we will assess the impact of the pandemic and update our expected timing accordingly.
The flexibility of TRUFORMA™’s technology offers a steady cadence of potential new product launches and test menu expansion beyond the thyroid and adrenal test menu, including non-infectious GI assays, novel renal and diabetes markers, immunoassays, molecular assays, whole blood samples, and multiplexing on the same platform.
“We believe TRUFORMA™’s innovative capabilities will be a major step forward in our efforts to bring reference lab testing capabilities to clinical veterinarians at the point-of-care,” said Stephanie Morley, DVM, and president at Zomedica. “We believe that the TRUFORMA™ platform has the potential to establish the Company as a leader in point-of-care diagnostic testing of companion animals in veterinary medicine.”
About Zomedica
Based in Ann Arbor, Michigan, Zomedica (NYSE American: ZOM) is a veterinary diagnostic 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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Forward-Looking Statements
Except for statements of historical fact, this news release contains certain “forward-looking information” or “forward-looking statements” (collectively, “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 and include statements relating to Zomedica’s expectations regarding the public offering. 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: 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; veterinary acceptance of our products; competition from related products; 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, risks related to the COVID-19 pandemic and its impact upon Zomedica’s business operations generally, including Zomedica’s ability to develop its diagnostic products, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR at www.sedar.com. 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:
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