Zomedica Announces Achievement of Product Development Milestones on its TRUFORMA™ Point-of-Care Diagnostic Platform

Source:  Zomedia Pharmaceuticals, Inc. 5/21/19

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.

About Zomedica
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.