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 ZomedicaBased 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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Forward-looking StatementsExcept 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 srampertab@zomedica.com +1 647.283.3630 PCG Advisory Group
Kirin Smith, COO ksmith@pcgadvisory.com +1 646.863.6519
Media Contact: Christy Penkacpenka@zomedica.com+1
734.369.2555
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/a0bb28f1-599f-4efa-a262-b176344cb60d
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