Diagnostic Testing Capabilities Improve in the Face of Global Turmoil

NEW YORK, Oct. 23, 2020 /PRNewswire/ -- While biotech companies work on vaccines and possible treatments and medical device companies focus on patient monitoring solutions, many others have been working on improving testing options. For example, numerous companies are now racing to develop antibody tests, also called serological tests, that can confirm whether someone was infected even after their immune system has cleared the virus. However, home tests are still not authorized in the U.S. The rapid at-home coronavirus tests could help bring the U.S.' surging outbreak under control, but the innovative medical firms are yet to develop tests that will convince regulators that the public can be trusted to use them correctly. "If this was a disease that only impacted the individual, then it wouldn't be such a problem," said Georges Benjamin, Executive Director of the American Public Health Association, according to a report by Politico. "The problem is that there will be a cohort of people who will take the test, find out that they are presumably negative, but they really weren't, and go out and infect other people." Todos Medical Ltd. (OTCQB: TOMDF), Adial Pharmaceuticals, Inc. (NASDAQ: ADIL), Pfizer Inc. (NYSE: PFE), Johnson & Johnson (NYSE: JNJ), Abbott (NYSE: ABT)

As of Monday afternoon, 8.2 million people had contracted Covid-19 in the U.S., according to NBC News numbers. More than 733,000 of those cases have been confirmed in the last two weeks. The country still falls behind many others on widescale testing, and experts claim that the lack of aggressive and consistent testing has contributed to the virus's spread. "If we really wanted to get things under control, frequent testing of almost everybody would be one way to do it and we're, of course, nowhere near that," Marc Lipsitch, a Professor of Epidemiology at the Harvard T.H. Chan School of Public Health, said. "We're doing infrequent testing of almost no one."

Todos Medical Ltd. (OTCQB: TOMDF) along with Adial Pharmaceuticals, Inc. announced breaking news yesterday that, "the companies have entered into a distribution agreement whereby Adial has granted Todos Medical non-exclusive sub-distribution rights to the Assure/FaStep® and EcoStep® point-of-care (POC) antibody tests (the "Tests"). The Assure/FaStep received the first U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a serology (antibody) POC test for COVID-19 using fingerstick blood samples as compared with current approved tests that only utilize serum, plasma, or a venous blood draw. See the FDA news release here.

As a result of the FDA's EUA, fingerstick blood samples can now be utilized with the Tests in POC settings, including doctors' offices, hospitals, urgent care centers, emergency rooms, or other locations where there is a licensed healthcare professional. The Tests were initially authorized for emergency use in July 2020, to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection, but as with all competing rapid COVID-19 test kits, were not yet authorized for fingerstick blood sample use.

'Adding a rapid, fingerstick antibody test that has received Emergency Use Authorization from the FDA as a point-of-care test to our portfolio is expected to dramatically increase the settings in which we are able to provide COVID-19 antibody testing for our growing list of clients,' said Gerald E. Commissiong, President and CEO of Todos Medical. 'We have now established a strong network of high-complexity CLIA lab clients who are implementing our PCR solutions, and we will now add rapid tests to our emerging pharmacy and skilled nursing facility point-of-care sales channel. We believe there is significant synergy in selling complementary COVID-19 tests in the marketplace.'

'This agreement with Todos adds a new element to our sales strategy,' said William Stilley, Chief Executive Officer of Adial Pharmaceuticals. 'Todos is seeking to provide comprehensive solutions for COVID-19 testing to their clients, and this agreement allows us to access a new category of clients for Adial. Our agreement was entered into following multiple sales of these Tests to Todos and therefore, we see a market demand from Todos' clients for these instant and efficient antibody tests to help combat the international COVID-19 pandemic.'

For information related to Todos Medical's COVID-19 testing capabilities, please visit www.todoscovid19.com

For our latest "Buzz on the Street" Show featuring Todos Medical Ltd. recent corporate news, please head over to: https://www.youtube.com/watch?v=GGXuMKaqe8s

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) along with Todos Medical announced yesterday that the companies have entered into a distribution agreement whereby Adial has granted Todos Medical non-exclusive sub-distribution rights to the Assure/FaStep® and EcoStep® point-of-care (POC) antibody tests (the "Tests"). The Assure/FaStep received the first U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a serology (antibody) POC test for COVID-19 using fingerstick blood samples as compared with current approved tests that only utilize serum, plasma, or a venous blood draw. 

Pfizer Inc. (NYSE: PFE) and BioNTech SE announced on October 6th, the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies' vaccine development program against COVID-19. The EMA's decision to start a rolling review follows the encouraging preliminary results from pre-clinical and early clinical studies in adults, which suggest that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. A combination of an antibody and T cell response is believed to be important in eliciting protection against viral infection and disease. BioNTech and Pfizer plan to work with the EMA's Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate the final Marketing Authorization Application (MAA). "It is our duty to ensure that while we are working to develop a potential vaccine at unprecedented speed to help address this pandemic, we do so with the highest ethical standards while adhering to sound scientific principles. We will continue to have regular and open dialogue with the EMA throughout the rolling review process," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

Johnson & Johnson (NYSE: JNJ) announced on September 23rd, the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Company's Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. These results have been submitted to medRxiv and are due to be published online imminently. Based on these results and following discussions with the U.S. Food and Drug Administration (FDA), ENSEMBLE will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19. "We remain fully focused on developing an urgently needed, safe and effective COVID-19 vaccine for people around the world," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. "We greatly value the collaboration and support from our scientific partners and global health authorities as our global team of experts work tirelessly on the development of the vaccine and scaling up our production capacity with a goal to deliver a vaccine for emergency use authorization in early 2021."

Abbott (NYSE: ABT) announced on October 12th that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test for use on the ARCHITECT® and Alinity™ platforms. IgM antibody testing can play an important role in understanding if someone has developed antibodies in response to the virus, indicating a recent or prior infection. "Abbott has developed tests to detect the virus at each stage of infection so doctors and their patients are equipped with knowledge of how they are responding to the virus and progressing through recovery," said Robert B. Ford, president and chief executive officer, Abbott. "Antibody tests will continue to play an important role to better understand the virus, the prevalence of COVID-19 in an area and where a patient may be in their recovery."

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