· Reauthorization of EUA expands beyond initial
qualitative detection claim
· CEO to appear on Cheddar News at 6:10pm
tonight, November 17th, 2021
New York, NY, and Tel Aviv, ISRAEL – 
(NewMediaWire) – November 17, 2021 – Todos
Medical, Ltd. (OTCQB: TOMDF), a
comprehensive medical diagnostics and related solutions company, today
announced that the United States Food & Drug Administration has
reauthorized the Emergency Use Authorization (EUA) for the cPass neutralizing
antibody test (“cPass”)*. The new indication for cPass now reads:
Qualitative and
semi-quantitative direct detection of total neutralizing antibodies to
SARS-CoV-2 in human serum and dipotassium EDTA plasma. Intended for use as an
aid in identifying individuals with an adaptive immune response to SARS-CoV-2,
indicating recent or prior infection. Emergency use of this test is limited to
authorized laboratories.
Concurrent with this
announcement, the Company announced that CEO Gerald Commissiong is to appear on
Cheddar News at 6:10pm tonight, November 17th, 2021.
For more information, please
visit www.todosmedical.com. For more information
on the Company’s CLIA/CAP certified lab Provista Diagnostics, Inc. please visit www.provistadx.com.
* This test has not been FDA
cleared or approved. This test has been authorized by FDA under an EUA for use
by authorized laboratories. This test has been authorized only for the presence
of total neutralizing antibodies against SARS-CoV-2, not for any other viruses
or pathogens. This test is only authorized for the duration of the declaration
that circumstances exist justifying the authorization of emergency use of in
vitro diagnostics for detection and/or diagnosis of COVID-19 under Section
564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.
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 deploys deep examination into 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 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 has entered into
distribution agreements with companies to distribute certain novel coronavirus
(COVID-19) test kits. The agreements cover multiple international suppliers of
PCR testing kits and related materials and supplies, as well as antibody
testing kits from multiple manufacturers after completing validation of said
testing kits and supplies in its partner CLIA/CAP certified laboratory in the
United States. Additionally, Todos has entered into a joint venture with NLC
Pharma to pursue the development of diagnostic tests targeting the 3CL protease,
as well as 3CL protease inhibitors that target a fundamental reproductive
mechanism of coronaviruses.
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 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 and Investor Contact:
Richard Galterio
Todos Medical
732-642-7770
rich.g@todosmedical.com