Talis Biomedical Corporation (Nasdaq: TLIS) today announced new
data supporting the development of its planned CT/NG/TV and vaginal
infection panels. Results from these studies, presented in poster
sessions at the 2023 IDSOG Annual Meeting in Denver, Colorado,
support Talis Biomedical’s mission to advance health equity and
outcomes through the delivery of accurate infectious disease
testing in the moment of need, at the point of care.
“The COVID-19 pandemic accelerated the development of numerous
molecular point-of-care platforms to bring rapid respiratory
testing closer to patients. Unfortunately, very few are designed to
effectively address the needs of women’s and sexual health,” said
Rob Kelley, chief executive officer at Talis Biomedical. “The
ability to lyse difficult targets and to purify and concentrate
nucleic acids to deliver lab quality results in less than 30
minutes is what we believe will set the Talis One system apart from
current platforms. These data presented at IDSOG give us confidence
we are on the path to developing viable and differentiated CT/NG/TV
and vaginal infection tests that can be performed at the point of
care, before a patient leaves the doctor’s office.”
Data Highlights from Talis Biomedical Presentations at
IDSOG Annual Meeting July 27-29, 2023:
Feasibility and preliminary performance of
development-stage CT/NG/TV test for Talis
One® system
A series of analytical studies were conducted to characterize
preliminary analytical sensitivity, exclusivity, inclusivity and
clinical performance of a development-stage CT/NG/TV test as part
of Talis Biomedical’s planned test menu.
To determine preliminary analytical sensitivity of its
sample-to-answer test in development to detect CT/NG/TV in less
than 30 minutes, company scientists co-spiked 20 self-collected
vaginal swabs and 7 male urine samples with live CT serovar D, NG
19424, and TV G3 for testing on the Talis One system. In females,
CT and TV were detected in 19/20 contrived vaginal swab samples at
concentrations of 1 IFU/mL and 5 cells/mL, respectively. NG was
detected in 20/20 vaginal swabs at a concentration of 50 CFU/mL. In
males, CT, NG, and TV were detected in 7/7 urine samples at
concentrations of 1.5 IFU/mL, 50 CFU/mL, and 5 cells/mL,
respectively.
To characterize exclusivity, closely related target organisms
tested at 1E6 units/mL or 1E5 genome copies/mL were not detected by
the Talis One development-stage CT, NG, or TV assays. Conversely,
the assays were inclusive of all strains and serovars.
Preliminary clinical performance of the Talis One
development-stage CT/NG/TV test was assessed using residual
clinical samples initially tested by widely used, on-market
molecular tests that require up to 90 minutes to generate a result.
In neat male urine, positive percent agreement (PPA) was 100% for
CT, NG and TV. Negative percent agreement (NPA) was 100% for CT and
NG, and 98% for TV. In female vaginal swabs where only positive
samples were tested, PPA was 100% for CT and NG, and 90% for
TV.
“As we approach this new era of STI testing, it is encouraging
to see a development-stage point-of-care CT/NG/TV assay achieve
clinical performance that is comparable to widely used on-market
tests being run at central laboratories,” said Glenn Harnett, M.D.,
chief executive officer at No Resistance, a clinical trial site
management organization and former chief medical officer at
American Family Care. “Access to STI test results during a single
patient visit will allow providers to make more informed treatment
decisions, reduce the use of unnecessary antibiotics, and provide
an opportunity for more directed and meaningful patient
education.”
On-cartridge bead beating differentiates Talis One lysis
for future development of vaginal panel
Talis Biomedical conducted a series of analytical studies to
test different mechanical lysis conditions on the Talis One system
to determine the feasibility of nucleic acid recovery from
difficult-to-lyse fungal pathogens.
Company scientists performed initial experiments to determine
lysis efficiency with and without beads added to the Talis One’s
on-cartridge mechanical (stir bar containing) lysis chamber. The
lysis conditions were evaluated and selected using intact Candida
albicans as a model pathogen. With stir bar mixing alone, target
nucleic acids were only detected 100% of the time (3/3) at 1000
CFU/mL. When beads (bead-beating) were added to the stir bar
containing lysis chamber on the Talis One cartridge, target nucleic
acids were detected 100% of the time (6/6) at concentrations as low
as 125 CFU/mL, delivering an 8-fold increase in lysis efficiency.
The lysis time was as short as 4 minutes.
Additional experiments performed to further challenge the Talis
One system included using contrived specimens of five different
Candida species diluted in a DNA/RNA transport and storage medium
at concentrations of 100,000, 10,000 and 1000 CFU/ml. The contrived
specimens were lysed using the Talis One’s bead beating, mechanical
lysis system. On bench detection was demonstrated down to the
lowest concentration tested (1000 CFU/ml in 3/3 replicates) for all
five Candida species.
These studies demonstrate that incorporating mechanical lysis on
the Talis One system led to lysing fungal cells and releasing
target nucleic acids for detection at a concentration level that is
comparable to the limits of detection (LODs) of three on-market
vulvovaginal candidiasis in vitro diagnostic (IVD) tests. Based on
these positive early results, Talis Biomedical may be able to
achieve these LODs while having a turnaround time that is
approximately 30-90 minutes faster.
“The availability of accurate and reliable point-of-care testing
for vaginitis will be invaluable in the women’s healthcare space.
More than 30 percent of women of all ages suffer from symptoms of a
vaginal infection and often receive deferred treatment with delays
in diagnosis,” said Annelise Skor Swigert, M.D., FACOG, medical
director, Premier Ob/Gyn of Minnesota. “I believe access to
immediate and definitive testing results would clearly have an
instant impact on care for these patients.”
Talis Biomedical plans to perform additional testing at lower
concentrations to determine the effectiveness of lysing each fungal
pathogen for amplification and detection. LODs will be confirmed
once a fully developed vulvovaginal candidiasis assay is integrated
on the Talis One test cartridge.
About the Talis One SystemThe Talis One system
is a compact, sample-to-answer molecular testing platform designed
to enable rapid, highly accurate point-of care infectious disease
testing in non-laboratory settings. The Talis One test cartridge is
a fully self-contained, closed device that includes all the
necessary reagents to perform a Talis One test. When loaded into
the Talis One instrument, each cartridge fully automates sample
lysis, nucleic acid extraction and purification, isothermal
amplification, and target detection. The Talis One test system is
not authorized, cleared, or approved by the FDA and is not
available for sale.
About Talis BiomedicalTalis Biomedical is
dedicated to advancing health equity and outcomes through the
delivery of accurate infectious disease testing in the moment of
need, at the point of care. The Company plans to develop and
commercialize innovative products on its sample-to-answer Talis
One® system to enable accurate, low cost, and rapid molecular
testing. For more information, visit talisbio.com.
Forward-Looking Statements This press release
may contain forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Words such as
“may,” “might,” “will,” “would,” “should,” “believe,” “expect,”
“anticipate,” “could,” “estimate,” “continue,” “predict,”
“potential,” “forecast,” “project,” “plan,” “intend” or similar
expressions, or other words that convey uncertainty of future
events or outcomes can be used to identify these forward-looking
statements. Forward-looking statements include statements regarding
our intentions, beliefs, projections, outlook, analyses or current
expectations concerning, among other things, the potential clinical
performance of assays on the Talis One system, or results of
additional research and development studies. These statements are
not guarantees of future performance and are subject to certain
risks, uncertainties and other factors that could cause actual
results and events to differ materially and adversely from those
indicated by such forward-looking statements including, among
others, the performance of future Company products, the Company’s
development pipeline, results of additional research and
development studies and other risks and uncertainties that are
described more fully in the “Risk Factors” section and elsewhere in
our filings with the Securities and Exchange Commission and
available at www.sec.gov, including in our Annual Report on Form
10-K and Quarterly Reports on Form 10-Q. These statements are based
upon information available to us as of the date of this press
release, and while we believe such information forms a reasonable
basis for such statements, such information may be limited or
incomplete, and our statements should not be read to indicate that
we have conducted an exhaustive inquiry into, or review of, all
potentially available relevant information. These statements are
inherently uncertain and investors are cautioned not to unduly rely
upon these statements. Any forward-looking statements that we make
in this announcement speak only as of the date of this press
release, and Talis Biomedical assumes no obligation to update
forward-looking statements whether as a result of new information,
future events or otherwise after the date of this press release,
except as required under applicable law.Contact
Media & InvestorsEmily
Faucetteefaucette@talisbio.com415-595-9407
Talis Biomedical (NASDAQ:TLIS)
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