Zomedica Pharmaceuticals Corp. (NYSE American: ZOM) (TSX-V: ZOM), a veterinary diagnostic and pharmaceutical company, is continuing to integrate innovative assays into its TRUFORMA™ point-of-care biosensor platform. On Wednesday, ZOM announced development progress on additional assays for the device, which they believe may become the first-ever point-of-care assay for canine endogenous adrenocorticotropic hormone (eACTH) and for feline thyroid stimulating hormone (feline TSH). The two developing tests demonstrates the utility, scalability, and potential of TRUFORMA™. The company also reiterated that diagnostic research efforts are continuing, and that the company intends to develop additional assays for TRUFORMA™, including non-infectious gastrointestinal, diabetes, and renal assays.
The innovative TRUFORMA™ platform and its growing set of assays are 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.
First Of A Kind Assay, TRUFORMA™ Brings Powerful Capabilities
The TRUFORMA™ biosensor platform is expected to launch in the first quarter of 2020 and may have a market-changing effect. To that point, Dr. Stephanie Morley, Chief Operations Officer and Vice President Product Development stated, “To our knowledge, no point-of-care device has the sensitivity and testing performance required to detect canine eACTH and feline TSH.” She added, “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.”
Zomedica is intending to bring to the market this revolutionary device to replace the current methods for diagnosing the two most common canine adrenal diseases, Cushing’s and Addison’s, that often require multiple visits, potential hospitalization of dogs for injections, and multiple blood draws over time. The current testing procedures can be expensive, cause stress to patients, and require significant veterinary staff time. The technology that Zomedica is bringing to market, particularly the availability of these two new assays at point-of-care, may have 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. Taking both speed and accuracy into account, Zomedica noted 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.
Huge Market Potential To Treat Cats Effectively And Quickly
Zomedica is also delivering an assay to help treat hyperthyroidism and chronic metabolic disorder in cats, a relatively common issue that often requires life-long treatment. Statistics show that an estimated 10 percent or more of all senior cats will develop hyperthyroidism. And, despite the high prevalence of the disorder, a specific feline TSH assay is not commercially available, either at reference labs or at the veterinary clinic. Zomedica appears poised to capitalize on that void.
Instead, veterinarians often 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. Similar to its promising data for its eACTH assay, preliminary assay performance data generated by Zomedica indicates that the TRUFORMA™ feline TSH assay can diagnose hyperthyroid cats with an analytical sensitivity as low as 0.01 ng/mL. Further, the preliminary results satisfy 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. And, adding significance to the TRUFORMA™ performance data, Zomedica expects time to result will be 15 minutes or less.
Expected TRUFORMA™ Launch In First Quarter Of 2020
TRUFORMA™ is working its way through the development process and is not currently available for sale. However, while the device is considered to be in its investigational stage of development, 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 the first quarter of 2020.
Beyond TRUFORMA™, Zomedica's pipeline of products includes four therapeutics that are targeting treatment opportunities for some of the most common disorders in pets and include two formulations of metronidazole for diarrhea, methimazole for hyperthyroidism, and transdermal fluoxetine for behavioral problems. Both the diagnostic and drug market opportunity can be substantial markets for ZOM, with diagnostic sales alone already surpassing $2 billion in 2018.
From an operating perspective, ZOM is exceptionally well managed, is bringing to market novel products, and enjoys a significant level of insider ownership of the stock. With Zomedica closing in on its first product launch early next year, combined with its pipeline of promising products that can fill unmet needs, the company is well-positioned for growth for the remainder of 2019 and into 2020.
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