Todos Medical Initiates Validation Plan for PCR-based MonkeyPox Test at CLIA/CAP Clinical Testing Laboratory Provista Diagnostics
August 03 2022 - 9:48AM
InvestorsHub NewsWire
§ Lesion swab (standard of care) and saliva-based
sample collection planned
§ Peer-reviewed publication demonstrating saliva
testing sensitivity opens door for asymptomatic testing
New York, NY, and Tel Aviv, Israel -- Aug. 03, 2022 --
InvestorsHub NewsWire -- Todos Medical, Ltd.
(OTCQB:
TOMDF), a comprehensive medical diagnostics and
related solutions company, today announced that its
CLIA/CAP-certified laboratory Provista Diagnostics has initiated a
validation plan for PCR-based MonkeyPox testing. Under the plan,
the Company is validating multiple PCR assays for MonkeyPox and
will launch the most sensitive for lesion-based and saliva-based
sample collections. While lesion-based testing is the current
standard of care according to CDC guidelines, saliva-based sample
collection is currently undergoing intense research that could open
up the potential for testing of asymptomatic or very early-stage
patients at high risk of severe disease (such as immunocompromised
patients) that could result in earlier diagnosis and early
intervention with therapeutic drugs such as Tecovirimat (TPOXX).
TPOXX is an investigational drug candidate, and currently only
available under an expanded access Investigational New Drug
(EA-IND) protocol. The MonkeyPox tests are being developed as
Laboratory Developed Tests (LDTs). A recent peer-reviewed article
describing strong correlation of the sensitivity of lesion and
saliva-based PCR testing was recently published in the journal
Eurosurveillance: https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2022.27.28.2200503
“The significant investment we made to automate PCR testing at
Provista to maximize COVID testing capacity can now be partially
redeployed towards MonkeyPox as we prepare to help the nation
scale-up MonkeyPox testing capacity to meet the emerging public
health crisis,” said Gerald E. Commissiong, President & CEO of
Todos Medical.
About Todos Medical Ltd.
Founded in Rehovot, Israel with offices in New York City, Todos
Medical Ltd. (OTCQB:
TOMDF) engineers life-saving diagnostic solutions for the early
detection of a variety of cancers. The Company's state-of-the-art
and patented Todos Biochemical Infrared Analyses (TBIA) is a
proprietary cancer-screening technology using peripheral blood
analysis that examines cancer's influence on the immune system,
looking for biochemical changes in blood mononuclear cells and
plasma. Todos’ two internally developed cancer-screening tests,
TMB-1 and TMB-2 have received a CE mark in Europe. Todos recently
acquired U.S.-based medical diagnostics company Provista
Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based
CLIA/CAP certified lab currently performing PCR COVID
testing, Long COVID
Panel, and Provista's proprietary commercial-stage Videssa®
breast cancer blood test.
Todos is also developing blood tests for the early detection of
neurodegenerative disorders, such as Alzheimer's disease. The
Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood
test that determines the ability of peripheral blood lymphocytes
(PBLs) and monocytes to withstand an exogenous mitogenic
stimulation that induces them to enter the cell cycle. It is
believed that certain diseases, most notably Alzheimer's disease,
are the result of compromised cellular machinery that leads to
aberrant cell cycle re-entry by neurons, which then leads to
apoptosis. LymPro is unique in the use of peripheral blood
lymphocytes as a surrogate for neuronal cell function, suggesting a
common relationship between PBLs and neurons in the brain.
Todos formed the Israeli-based majority-owned joint venture 3CL
Pharma, Ltd with NLC Pharma in March of 2022 to consolidate all of
the intellectual property pursuing the development of diagnostic
tests targeting the 3CL protease, as well as 3CL protease inhibitor
botanical and pharmaceutical products that target a fundamental
reproductive mechanism of coronaviruses. 3CL Pharma, through Todos’
brand, has commercialized the 3CL protease inhibitor immune support
dietary supplement Tollovid® in the United States, is developing
the dual mechanism 3CL protease inhibitor & anti-cytokine
therapeutic drug candidate Tollovir®, while also developing the 3CL
protease inhibitor diagnostic TolloTest™.
To purchase Tollovid please visit Amazon or www.MyTollovid.com.
For more information, please visit https://www.todosmedical.com/.
Forward-looking Statements
Certain statements contained in this press release may constitute
forward-looking statements. For example, forward-looking statements
are used when discussing our expected clinical development programs
and clinical trials. These forward-looking statements are based
only on current expectations of management, and are subject to
significant risks and uncertainties that could cause actual results
to differ materially from those described in the forward-looking
statements, including the risks and uncertainties related to the
progress, timing, cost, and results of clinical trials and product
development programs; difficulties or delays in obtaining
regulatory approval or patent protection for product candidates;
competition from other biotechnology companies; and our ability to
obtain additional funding required to conduct our research,
development and commercialization activities. In addition, the
following factors, among others, could cause actual results to
differ materially from those described in the forward-looking
statements: changes in technology and market requirements; delays
or obstacles in launching our clinical trials; changes in
legislation; inability to timely develop and introduce new
technologies, products and applications; lack of validation of our
technology as we progress further and lack of acceptance of our
methods by the scientific community; inability to retain or attract
key employees whose knowledge is essential to the development of
our products; unforeseen scientific difficulties that may develop
with our process; greater cost of final product than anticipated;
loss of market share and pressure on pricing resulting from the
competition; and laboratory results that do not translate to
equally good results in real settings, all of which could cause the
actual results or performance to differ materially from those
contemplated in such forward-looking statements. Except as
otherwise required by law, Todos Medical does not undertake any
obligation to publicly release any revisions to these
forward-looking statements to reflect events or circumstances after
the date hereof or to reflect the occurrence of unanticipated
events. For a more detailed description of the risks and
uncertainties affecting Todos Medical, please refer to its reports
filed from time to time with the U.S. Securities and Exchange
Commission.
Todos Corporate Contact:
Daniel Hirsch
CFO
Todos Medical
917-983-4229 x 104
Dan.h@todosmedical.com
Todos Med (CE) (USOTC:TOMDF)
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