LexaGene Completes Multi-Center Validation Study Using MiQLab® System for Diagnosing Urinary Tract Infections
July 27 2022 - 7:58AM
LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG)
(“LexaGene” or the “Company”), a molecular diagnostics company that
has commercialized the MiQLab® System for automated PCR-based
syndromic testing in veterinary clinics, provides a brief summary
of preliminary data collected during a clinical validation study
conducted at two of the top five veterinary universities in the
nation.1
The study was led by Professor Dr. Jane
Sykes BVSc (Hons), PhD, MBA, DACVIM (SAIM) at the University
of California-Davis (UC Davis). Urine specimens were also tested in
the laboratory of Dr. Stephen Cole MS, VMD at PennVet, University
of Pennsylvania (UPENN). Each site operated a MiQLab System
equipped with a MiQLab Bacterial and AMR Test V2, which screens
samples for 10 common pathogens and 33 markers for antimicrobial
resistance factors. MiQLab System data were compared to standard
culture and susceptibility testing.
The study was conducted in prospective manner. A
total of 105 urine specimens were tested across the two sites, of
which, 39 were deemed to be clinically relevant for a urinary tract
infection. The MiQLab System successfully detected all Escherichia
coli, Staphylococcus, Proteus, Klebsiella, Enterococcus faecium,
and Enterococcus faecalis positive samples. One positive
Streptococcus sample was not detected. When the entire data set of
successful runs were compiled the sensitivity of the MiQLab System
using the MiQLab Bacterial and AMR Test V2 for detecting pathogens
was 97%, specificity was 91%, agreement was 93%, and kappa
agreement was 0.86 (almost perfect).
These data were presented in a live webinar last
night at 7 PM ET. The webinar was hosted by DVM360 and
moderated by Adam Christman, DVM, MBA. A recording of this webinar
will be made available by DVM360 in approximately one weeks’ time
on their website (https://ce.dvm360.com/)
Dr. Jack Regan stated, “We are very pleased by
these data as they show the MiQLab System provides
reference-laboratory quality results in just 2 hours rather than
days. The results of this study allowed us to further refine the
performance of both the instrument and diagnostic test components,
such as the Streptococcus assay. The results of preliminary testing
following these refinements are extremely positive.”
On Behalf of the Board of DirectorsDr.
Jack ReganChief Executive Officer &
Chairman
To learn more about LexaGene and the MiQLab System or subscribe
to company updates, visit www.lexagene.com, or follow us on Twitter
or LinkedIn.
For inquiries: 800.215.1824 | ir@lexagene.com or
info@lexagene.com
About LexaGene Holdings
Inc. LexaGene
is a molecular diagnostics company that has commercialized the
MiQLab® System for fast and easy detection of pathogens and other
molecular markers. The System is PCR-based, screens for 24 targets
at once, and is designed for on-site usage. Our customers include
veterinary hospitals and reference laboratories – as well as
contract biologic manufacturers. The MiQLab System delivers
excellent sensitivity, specificity, and breadth of detection and
returns results in approximately two hours. The MiQLab System is
also open-access, which allows end-users to load their own PCR
assays onto the System 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.
1https://www.usnews.com/best-graduate-schools/top-health-schools/veterinarian-rankings/21775470034_control
Lexagene (TSXV:LXG)
Historical Stock Chart
From Jun 2024 to Jul 2024
Lexagene (TSXV:LXG)
Historical Stock Chart
From Jul 2023 to Jul 2024