Todos Medical announces the commercialization of the MonkeyPox PCR test based on lesions and saliva

  • Provista begins validation preparations for IgM/IgG MonkeyPox LDT in blood
  • The company will launch its Q2/2022 10Q quarterly report on 16:05 ET this afternoon
  • The company will hold a business update conference call on Tuesday, August 23dr a 08:30 a.m. Eastern Time

New York, NY, Alpharetta, GA and Tel Aviv, ISRAEL, August 22, 2022 (GLOBE NEWSWIRE) — via NewMediaWireAll Physicians, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its Atlanta-area CLIA/CAP-certified clinical laboratory, Provista Diagnostics, Inc., has completed CLIA validation and has MonkeyPox PCR-Based Test Launched Commercially in the United States.

The sensitivity achieved for the currently available lesion-based laboratory developed test (LDT) is 1.2 viral copies per reaction (0.12 copies/ul), with identical sensitivity (1.2 viral copies per reaction) achieved for their saliva-based test that has also completed CLIA validation protocols. Provista also completed the implementation of updated safety protocols to meet CDC recommended protocols for MonkeyPox, which are in line with Biosafety Level 3 (BSL3) laboratory protocols. Provista will collect saliva samples combined with swabs from lesions from confirmed cases of MonkeyPox before launching a stand-alone LDT aimed at identifying MonkeyPox at the pre-symptomatic stage. In situations of known exposure to confirmed or suspected cases of MonkeyPox for which there are no symptoms, Provista intends to make available saliva-based MonkeyPox PCR tests that may make them eligible for MonkeyPox Jynneos or Tecovirimat vaccine antiviral therapy. (TPoxx) approved by the FDA under an Early Access Investigational New Drug (EA-IND) application through the CDC, in partnership with the US Food and Drug Administration (FDA). Other uses for the MonkeyPox PCR Test include sewage surveillance, as well as wildlife surveillance to understand if animal populations are beginning to carry a viral reservoir that could eventually spread to new human populations. The company is also preparing validation plans for an IgM/IgG blood-based MonkeyPox LDT to confirm a recent infection as part of a planned MonkeyPox Panel.

“We are positioning Provista to become a leader in MonkeyPox testing given that MonkeyPox has recently been designated a public health emergency by the US government and as such there is an urgent need to increase the availability of tests to facilitate the containment of outbreaks. ”, said Gerald E. Commissiong, president and chief executive officer of Todos Medical. “Anyone can become infected with MonkeyPox through skin-to-skin contact, sexual intercourse, skin contact with virus-laden surfaces such as bed sheets, as well as through prolonged exposure to MonkeyPox-laden aerosols and/or respiratory droplets. . MonkeyPox has an incubation period of up to three weeks. During the current outbreak of MonkeyPox in the US, the virus is being diagnosed primarily in the gay male community. However, recent contagion in women, children, and infants has been documented, raising the possibility of a broader outbreak that could reach wider circulation in the general population. As such, it is imperative to support the gay male community and the broader community mitigation efforts by making MonkeyPox testing more widely available in ways that allow patients to be diagnosed earlier, hopefully during the pre-symptomatic stage where it is likely make the intervention more effective.

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Mr. Commissiong continued: “Currently, the US has the capacity to test approximately 80,000 samples per week. If we’re going to contain MonkeyPox and prevent it from becoming endemic in the United States, we need to drastically increase testing of not only lesion-based samples that require someone’s infection to become symptomatic, but also saliva-based samples that are likely to provide the best chance. to diagnose patients much earlier in the pathogenesis of the disease. Provided currently has PCR automation capacity to run 25,000 PCR tests per day, or 175,000 PCR tests per week, with ongoing efforts to increase this capacity to 50,000 PCR tests per day, or 350,000 PCR tests per week. week. Additionally, our materials supplier that enabled us to rapidly complete our LDT development has sufficient capacity to manufacture and deliver over 1,000,000 PCR assays per week for the US market, which we also intend to deploy as needed to through our Corona Diagnostics distribution arm. to our customers and assist them with assay validation should testing beyond Provista’s capabilities become necessary. The availability of this increased testing capacity and supply of materials to assist in MonkeyPox’s public health emergency mitigation efforts in the US, along with saliva testing for mildly symptomatic and asymptomatic individuals, will provide the opportunity to dramatically accelerate contact tracing efforts by serially testing exposed people in order to give the individual greater certainty that they are not infected or contagious, and give them the best chance they need to break chains of infection.”

Concurrent with this announcement, the Company will release its quarterly financial statements for the second quarter of 2022 after the market close at 4:05 pm ET and hold a business update conference call on Tuesday, August 23.dr2022 at 8:30 am Eastern time.

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About All Medical Ltd.

Founded in Rehovot, Israel, with offices in New York City, Todos Medical Ltd. (OTCQB: TOMDF) designs life-saving diagnostic solutions for the early detection of a variety of cancers. The company’s next-generation, patented All-Biochemical Infrared Assay (TBIA) is a proprietary cancer detection technology that uses peripheral blood tests that examine the influence of cancer on the immune system, looking for biochemical changes in blood mononuclear cells. and the plasma. The two cancer detection tests developed in-house by Todos, TMB-1 and TMB-2, have received the CE mark in Europe. Todos recently acquired US-based medical diagnostics company Provista Diagnostics, Inc. to obtain the rights to its CLIA/CAP certified laboratory based in Alpharetta, Georgia, which currently performs COVID PCR tests, Long COVID Dashboard analyzeand Videssa of commercial stage owned by Provista® breast cancer blood test. More information about Provided is available at www.provistadx.com.

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 (PBL) and monocytes to resist exogenous mitogenic stimulation that induces them to enter the cell cycle. Certain diseases, most notably Alzheimer’s disease, are thought to be the result of compromised cellular machinery leading to aberrant cell cycle reentry by neurons, which then leads to apoptosis. LymPro is unique in its 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 Israel-based majority-owned joint venture 3CL Pharma, Ltd with NLC Pharma in March 2022 to consolidate all intellectual property related to 3CL protease-based diagnostic tests and the development of botanical and pharmaceutical inhibitors of the 3CL protease that target a critical reproductive system. coronavirus mechanism. 3CL Pharma, through the Todos brand, has marketed the 3CL Tollovid protease inhibitor immune support dietary supplement in the United States, is developing the dual-mechanism 3CL protease inhibitor and anti-cytokine therapeutic drug candidate Tollovirwhile developing the 3CL TolloTest™ protease diagnostic.

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To buy Tollovid, visit Amazon either 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 clinical development programs and expected clinical trials. These forward-looking statements are based solely on management’s current expectations 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 risks and uncertainties related to 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 biotech companies; and our ability to obtain the additional funds necessary to carry out 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; failure to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we go forward 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; higher cost of the final product than anticipated; loss of market share and price pressure from competition; and laboratory results that do not translate to equally good results in real world settings, all of which could cause actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical undertakes no obligation to publish any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unforeseen events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed periodically with the US Securities and Exchange Commission.

All Corporate Contact:
Daniel Hirsch
CFO
All Medical
917-983-4229×104
[email protected]

All press contacts:
Kyle Kappmeier
jconnelly
Vice president
973-975-7827
[email protected]


Todos Medical announces the commercialization of the MonkeyPox PCR test based on lesions and saliva Todos Medical Ltd

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