LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the
“
Company”), a molecular diagnostics company that
develops fully automated rapid pathogen detection systems, is
pleased to host a private event for a select group of veterinarians
that will feature keynote speaker Dr. Shelley Rankin, Professor of
Microbiology at the University of Pennsylvania’s School of
Veterinary Medicine (Penn Vet), who will present data on her
experience using LexaGene’s MiQLab to detect Staphylococcus in
specimens collected from canine skin infections. In addition, Dr.
Jack Regan, LexaGene’s CEO and Founder, will provide some
introductory remarks on the use of molecular diagnostics in
veterinary medicine and present some analytical and clinical data
generated using LexaGene’s MiQLab system. Any information thought
to be of material nature for this seminar is described below.
To demonstrate the performance of LexaGene’s MiQLab to detect
common bacterial pathogens encountered in veterinary medicine, Dr.
Rankin and LexaGene teamed up to perform a series of analytical and
clinical studies. For the analytical studies and clinical urine
study, MiQLabs were equipped with LexaGene’s MiQLab™ Bacterial and
AMR Test, which screens samples for 7 of the most common bacterial
pathogens found in companion animals, as well as 13 different
antimicrobial resistance factors.
Dr. Rankin’s evaluation focused on skin and soft tissue
infections in dogs, which are commonly caused by Staphylococcus
pseudintermedius (SP) and Staphylococcus schleiferi (SS). Treating
these infections using empiric therapy is a challenge because it
has been shown that up to 59% of SP isolates from canine pyoderma
can harbor the mecA gene, which confers resistance to all
beta-lactam drugs.1 Rapid in-clinic molecular diagnostics that can
detect Staphylococcus and the presence of the mecA gene will, in
most cases, allow veterinarians to prescribe an appropriate
antibiotic. It is well known that antibiotic use can contribute to
the problem of drug resistance in bacteria and inappropriate use of
antibiotics is highly discouraged in veterinary medicine. For that
reason, it is very important to know quickly if the mecA gene is
present in the Staphylococcus species causing the infection. For
this study, 23 skin specimens, that were confirmed by culture to
contain SP or SS, were tested with the MiQLab. Staphylococcus was
detected in 21 of these specimens (91%). Similarly, antimicrobial
susceptibility testing showed the MiQLab detected the mecA gene in
8 of 9 (89%) of the Staphylococcus isolates that were cultured and
found to be resistant to methicillin. These data signify that
veterinarians using MiQLab in their clinic can prescribe therapy
with confidence based on genetic analysis. This will improve
clinical outcomes and minimize the development of drug resistant
bacteria.
Dr. Rankin comments, “LexaGene’s MiQLab returns a molecular
analysis on specimens in a fraction of the time it takes for
culture to return results. As a result, veterinarians using MiQLab
can rule-out, or rule-in, infection and therefore offer pet owners
evidence-based treatment decisions for their pets on the same day
of the clinical appointment. In this day and age, when antibiotic
resistance is common in many veterinary pathogens, veterinarians
are looking for new technologies to minimize the use of unnecessary
or non-efficacious antibiotics and improve patient outcomes.”
LexaGene’s staff completed a second clinical study that focused
on detecting the pathogens responsible for urinary tract infections
in cats and dogs. For this study, 51 frozen canine urine samples
(25 positive and 26 negative samples) that were previously tested
by culture were processed on MiQLab. Six different pathogens were
detected from the processed samples, including 14 E. coli, 7
Staphylococcus, 5 Enterococcus, 3 Streptococcus, and 1
Enterobacter. Three of the samples contained antimicrobial
resistance factors. The MiQLab test results had a positive percent
agreement of 100% (95% CI: 88.7% - 100%), negative percent
agreement of 98.5% (95% CI: 96.5% - 99.3%) and overall percent
agreement of 98.6% (95% CI: 96.8% - 99.40%), with culture.
LexaGene’s staff also completed two analytical studies. The
first was performed to determine the MiQLab’s limit of detection
(LoD) for the most common pathogen responsible for urinary tract
infections in cats and dogs, namely Escherichia coli. In this
study, a total of 28 samples were processed on four different
MiQLabs and the LoD was determined to be 1x104 colony forming units
per milliliter (cfu/mL) for E. coli. This LoD is low enough to
detect the vast majority of infections considered to be clinically
relevant.2 Furthermore, these data can be quickly
generated inside the clinic, avoiding the 24 hr+ time it takes to
get results back when samples are shipped to a reference laboratory
for testing.
The second analytical study looked to provide insight into how
the semi-quantitative nature of the MiQLab correlates to the cfu
measurements reported when samples are cultured. For this study, E.
coli and Proteus mirabilis samples were tested in 5-point log-scale
dilution series from 5x103 to 7x108 cfu/mL. MiQLab generated Cycle
of Quantification (Cq) values were correlated to culture cfu/mL
counts and fit to a linear curve, and the calculated regression
coefficients (r2) were found to be 0.96 and 0.94, respectively for
E. coli and P. mirabilis. These data signify that the Cq values
reported by the MiQLab correlate extremely well with the cfu/mL
counts provided from traditional culture methods, which can be
useful for tracking whether an administered antibiotic is having
the desired effect.
Dr. Jack Regan concludes, “Our goal has always been to have the
MiQLab generate high quality data inside veterinary clinics where
veterinarians can use this data to guide treatment decisions. These
data prove we have achieved this goal. Our sales team will be using
these data to secure sales in the veterinary market, which has
relatively few options for quality in-hospital pathogen
testing.”
To be added to the LexaGene email list, please subscribe on the
Company website.
On Behalf of the Board of DirectorsDr.
Jack ReganChief Executive Officer &
Chairman
About LexaGene Holdings Inc.LexaGene is a
molecular diagnostics company that develops molecular diagnostic
systems for pathogen detection and genetic testing for other
molecular markers for on-site rapid testing in veterinary
diagnostics, food safety and for use in open-access markets such as
clinical research, agricultural testing and biodefense. End-users
simply need to collect a sample, load it onto the instrument with a
sample preparation cartridge, enter sample ID and press ‘go’. The
MiQLab™ system delivers excellent sensitivity, specificity, and
breadth of detection and can return results in approximately one
hour. The unique open-access feature is designed for custom testing
so that end-users can load their own real-time PCR assays onto the
instrument to target any genetic target of interest.
The TSX Venture Exchange Inc. has in no way
passed upon the merits of the proposed transaction and has neither
approved nor disapproved the contents of this press release.
Neither TSX Venture Exchange nor its Regulation Services Provider
(as that term is defined in the policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
This news release contains forward-looking information, which
involves known and unknown risks, uncertainties and other factors
that may cause actual events to differ materially from current
expectation. Important factors -- including the availability of
funds, the results of financing efforts, the success of technology
development efforts, the cost to procure critical parts,
performance of the instrument, market acceptance of the technology,
regulatory acceptance, and licensing issues -- that could cause
actual results to differ materially from the Company's expectations
as disclosed in the Company's documents filed from time to time on
SEDAR (see www.sedar.com). Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date of this press release. The company disclaims
any intention or obligation, except to the extent required by law,
to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
1 Lynch SA, Helbig KJ. The Complex Diseases
of Staphylococcus pseudintermedius in Canines: Where to
Next?. Vet Sci. 2021;8(1):11. Published 2021 Jan 18.
doi:10.3390/vetsci80100112 Weese, J.S., Blondeau, J.M., Boothe, D.
et al. Antimicrobial use guidelines for treatment of urinary tract
disease in dogs and cats: antimicrobial guidelines working group of
the international society for companion animal infectious diseases.
Veterinary Record 2011. doi: 10.4061/2011/26376
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