Zomedica Completes Verification of its TRUFORMA™ Point-of-Care Diagnostic Platform and the First Assay, Canine total T4
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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
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
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
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Source: Zomedica Pharmaceuticals Corp.