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Todos Medical CEO says company has notfied FDA of its plan to distribute its COVID-19 test kits to US labs

The kits demonstrated 100% sensitivity and 100% specificity in the company's validation protocols, according to CEO Gerald Commissiong

Todos Medical Ltd. - Todos Medical Ltd CEO Gerald Commissiong says the company has notified the US Food and Drug Administration of its intent to distribute its proprietary qPCR testing kits to high complexity labs performing COVID-19 testing in the US
The CEO noted the company is looking at the use of Vitamin C and Vitamin D to boost the immune system to defend against COVID-19 

Todos Medical Ltd (OTCQB:TOMDF) CEO Gerald Commissiong said the company has notified the US Food and Drug Administration of its intent to distribute its proprietary qPCR testing kits to high complexity labs performing COVID-19 testing in the US. 

The kits demonstrated 100% sensitivity and 100% specificity in the company's validation protocols, according to the CEO.

So far, the Israeli company has entered into COVID-19 testing supply contracts with five high complexity CLIA labs that its anticipates will generate over $36.5 million dollars in revenue over the next eight months — money which could help fund other business lines such as cancer and Alzheimer’s testing. The company also sees opportunities in targeting mobile testing labs.

READ: Todos Medical gains exclusive rights to distribute dietary supplement NLC-001 under partnership with NLC Pharma

“We are now working to significantly expand the market opportunity for our test by adding key features, such as testing for influenza A and B, as well as expand the number of instruments capable of running our kits in the United States,” Commissiong said in a letter to shareholders on Friday. 

“We expect that as the capacity for PCR testing in the United States continues to increase nationally, the market opportunity for our kits continues to grow weekly as labs realize that without a COVID-19 testing business they may lose testing business from clients in other areas because of the increasing need for testing in skilled nursing facilities and physician’s offices.” 

In addition, with Todos’ PCR testing business taking hold, Commissiong said the company is looking to solve other key problems in the COVID-19 testing landscape by securing access to a suite of rapid antigen tests that are currently in the Emergency Use Authorization (EUA) application process, awaiting approval. 

“The market need for rapid COVID testing so far is outpacing the science, and so we continue to believe that innovation will continue in the screening process for COVID-19,” he said. 

“We are also developing our own proprietary 3CL Protease-based saliva-based test for COVID-19 that is based on a molecular target needed to identify active virus which we expect will be an order of magnitude better test than antigen testing because we are targeting the identification of active virus in the system, as opposed to identifying both active and inactive virus as the antigen tests do – which creates the potential for higher numbers of false positives.” 

Commissiong told shareholders that the company expects to submit a EUA application in the fourth quarter of 2020 to the FDA for its proprietary 3C protease saliva-based test currently under development in Israel.

Use of dietary supplements to help fight Covid

Meanwhile, the CEO noted that the company is looking at the use of dietary supplements Vitamin C and Vitamin D to boost the immune system to defend against COVID-19. 

“As such, combining an approach of improving the body’s cellular immune function through vitamin C and vitamin D along with a product that could help slow the replication of SARS-CoV-2 virus would be a further advancement to help support and maintain health immune function in the face of the global COVID-19 pandemic,” Commissiong said.

Development of a vaccine

As for the potential development of a vaccine, he said the company’s joint venture partner NLC has been developing NLC-001, a natural 3CL protease inhibitor obtained from plant extracts which could become an important part of an overall herd immunity strategy that governments are beginning to deploy through their focus on vaccines. 

“While we believe vaccines will ultimately be the key to getting back to normal life, there are significant scientific, medical and logistical hurdles to getting there, and so there is a significant opportunity to help facilitate this transition by supporting and maintaining healthy immune function, and we believe NLC-001 could play an important role in that process alongside other dietary supplements,” Commissiong said.

Nasdaq uplist?

Todos also has been evaluating how best to achieve a national listing on the Nasdaq. In the meantime, in a show of support for shareholders, the CEO said the company has agreed to cease diluting its common stock for approximately one month at no cost to the company.

“In conclusion, 2020 has shown the resilience of Todos Medical. Instead of seeing the global pandemic as a reason to slow our operations, we viewed it as a unique opportunity in human history to make significant improvements to the world’s testing infrastructure so that we can build a future of better, faster health information that is actionable and focused on wellness by supporting the body’s immune function,” he said. 

“These are megatrends that were in process prior to this pandemic, and that were dramatically accelerated as a result of market need. The testing infrastructure we are establishing for COVID-19 will be leveraged to deploy our cancer and Alzheimer’s testing solutions, and we believe this will be extremely important for Todos as we look towards the future as we bring our portfolio to market.”

Contact the author: [email protected]

Follow him on Twitter @PatrickMGraham

 

 

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Price: 0.058 USD

OTCQB:TOMDF
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Market Cap: $11.71 m
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