- Full US use of ANDiS 350 extraction systems would
increase US daily testing capacity by
25%
- 3D Med extraction capacity increased by 1,000,000
kits per week
- Extraction reagent and automation scarcity
spiking as US COVID-19 PCR demand
surges
- 3D Med system successfully completes ‘pool
testing’ validation for ANDiS 350
- Todos gains branding rights to 3D Med COVID-19
products in the United States
REHOVOT,
Israel, NEW YORK, NY and Shanghai, China -- July 10, 2020 --
InvestorsHub NewsWire -- Todos Medical Ltd. (OTCQB:
TOMDF), an in vitro diagnostics company
focused on the distribution of a comprehensive suite of solutions
for the screening and diagnosis of COVID-19 and the development of
blood tests for the early detection of cancer and Alzheimer’s
disease, today announced that it has expanded its agreement with 3D
Medicines Corporation for COVID-19 testing
products.
Under the terms
of the newly signed Medical Device Contract Manufacturing
Agreement, Todos has been granted the exclusive right to seek out
US Food & Drug Administration (FDA) Emergency Use Authorization
(EUA) for 3D Med’s SARS-CoV-19 and, as well as exclusive branding
and distribution rights to 3D Med’s qPCR test kits in the United
States. 3D Med recently completed an expansion of its extraction
reagent manufacturing capacity, by adding 1,000,000
extraction reagent production per week (~140,000 per day) that can
be used towards deployment in the
US.
The current
daily testing volume in the United States is approximately 550,000
tests/day. The full deployment of 3D Med’s additional extraction
capacity would allow for an increase of approximately 25% in total US testing
capacity per day. Todos has completed validation of 3D Med’s qPCR
kits and pre-loaded extraction reagents and automated machines at
its partner CLIA/CAP certified lab Provista Diagnostics, Inc. in
Alpharetta, GA.
Additionally, 3D
Med has successfully validated ‘pool testing’ at a ratio of 10:1,
and Todos intends to complete ‘pool testing’ validation here in the
United States in the next several weeks so that it can seek US FDA
EUA over the summer of 2020 and be ready to deploy pool testing
broadly for Back to School and Return to Work testing, which Todos
expects to ramp up significantly in the second half of Q3/2020.
Pool testing of 10:1 would potentially increase capacity to a
maximum of 1,400,000 tests per
day.
“It is now
unequivocally clear that PCR testing is the gold standard in the
United States for the foreseeable future, until new molecular
technologies are able to reach the scale of current PCR testing,”
said Gerald Commissiong, President & CEO of Todos Medical. “We
are very pleased with the relationship we are building with 3D Med,
especially as we see demand for extraction machines and reagents
begin to really take off as smaller, independent labs begin to get
involved in COVID-19 testing and they identify access to a stable
supply of extraction reagents as the rate limiting step to market
entry. We have started to ramp up sales, including a recent marquee
sale of our ANDiS machines to the Cleveland Clinic, and we
are now helping our clients get up and running so they can quickly
expand their testing capacity. As we move into the next phase of
growth for our emerging COVID-19 testing business, we are upselling
our growing install base with Gnomegen qPCR kits and related
materials so that Todos can compete effectively with
competitors who tend to be focused on national and regional labs in
the US. Our small and medium sized lab customer base greatly
appreciates the availability of our extraction equipment and
reagents.”
Separately,
Todos expanded its international distribution rights to 3D Med’s
COVID-19 testing products to include the United States, Israel,
Singapore, Malaysia, Indonesia, Thailand, Myanmar, Vietnam,
Philippine, Cambodia/Laos, Hong Kong, Japan, South Korea, Taiwan,
India, United Kingdom, France, Sweden, Italy, Germany, Romania,
Austria, Monaco, Switzerland, the Balkans, India, Gulf States,
Dubai, UAE, Argentina, Aruba, Bahamas, Barbados, Belize, Bolivia
(Plurinational State of), Mexico, Canada, Brazil, Chile, Colombia,
Costa Rica, Dominican Republic, Ecuador, El Salvador, Martinique,
Grenada, Guatemala, Guyana, Haiti, Honduras, Jamaica, Nicaragua,
Panama, Paraguay, Peru, Saint Kitts and Nevis, Suriname, Trinidad
and Tobago, Uruguay, Venezuela (Bolivarian Republic of), Dominican
Republic of Congo, Madagascar, Zimbabwe, Lesotho, Botswana, Angola,
Zambia and South Africa.
For information
related to Todos Medical’s COVID-19 testing capabilities, please
visit todoscovid19.com
For testing and
PPE inquiries, please email sales@todosmedical.com
About Todos
Medical Ltd.
Headquartered in Rehovot, Israel, 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 and are currently in a pre-commercial study with its
distribution partner Orot+ (a division of Luces-Orot). Todos
recently entered into an exclusive option agreement to acquire
U.S.-based medical diagnostics company Provista Diagnostics, Inc.
to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified
lab and Provista's proprietary commercial-stage Videssa® breast
cancer blood test. The transaction is expected to close in the
third quarter of
2020.
Through Breakthrough Diagnostics, Inc., its joint
venture with Amarantus Bioscience Holdings, Inc. (OTC:
AMBS), Todos is also actively involved with the development of
blood tests for the early detection of neurodegenerative disorders,
such as Alzheimer's disease. Todos expected to complete the
remaining unowned interest in Breakthrough in the third quarter of
2020.
Todos has entered into distribution agreements with
companies to distribute certain novel coronavirus (COVID-19) test
kits. The Company has entered into distribution agreements with
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. Todos, via its wholly-owned subsidiary Corona
Diagnostics LLC, has formed strategic partnerships with Meridian
Health, Moto-Para Foundation, Emerald Organic Products, Inc.’s
(OTC:
EMOR) subsidiaries Carie.com and Bonsa Health to help
deploy COVID-19 testing in the United
States.
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.
Investor and
Corporate
Contact:
Kim Sutton
Golodetz
LHA Investor
Relations
Senior Vice
President
(212)
838-3777
kgolodetz@lhai.com
Corporate
Contact:
Daniel
Hirsch
Todos
Medical
(347)
699-0029
Dan.h@todosmedical.com
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