Times of Global Turmoil Reinforce the Need for Advanced Diagnostic Capabilities

NEW YORK, Aug. 17, 2020 /PRNewswire/ -- The diagnostics industry is a large and diverse entity, with new innovative technology constantly being developed. Diagnostic tests are usually conducted in laboratories, private or public, which are equipped with appropriate and sometimes expensive instrumentation and staffed with trained and qualified personnel to perform the tests. There are also various types of diagnostic methods including In Vitro Diagnostics (IVD), Point of Care (POC), Molecular diagnostics, genomic diagnostics and others. During a pandemic, in addition to the research necessary to develop a vaccine, accelerated R&D also focuses on diagnostic techniques, specifically on the scope of blood testing services throughout the industry. For example, various antibody tests are currently in development, also called serological tests, that can confirm whether someone was infected even after their immune system has cleared the virus. Todos Medical Ltd. (OTC: TOMDF), Aytu BioScience, Inc. (NASDAQ: AYTU), CytoDyn Inc. (OTC: CYDY), iBio, Inc. (NYSE: IBIO), Pfizer Inc. (NASDAQ: PFE) 

The diagnostics test manufacturing industry is under immense pressure due to the pandemic. The rapid growth in global demand for accurate and fast testing results is unlike anything the market has experienced before. Test makers are now tasked with scaling up production up from millions of tests per month to millions per week, and the material needed are not always available to achieve this goal. In the meantime, the biotech industry is driven by the similar concerns like viral infections and cancer, and is investing in innovative therapies. According to Labiotech, Matt Kapusta, CEO of uniQure, explained that "biotech is typically first in highly innovative fields. Typically, pharma is more earnings-conscious and thinks that if a biotech can prove an innovative technology works, then the company will collaborate or acquire its way in."

Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news last week that, "it has entered into an agreement with a South Korean manufacturer of rapid diagnostic tests, for U.S. distribution rights to its proprietary 10-minute rapid point-of-care  (POC) antigen test (Rapid Antigen) and its proprietary 40-minute rapid POC PCR test (Rapid PCR) for SARS-CoV-2.

Both tests will allow for more convenience and greater access for U.S. consumers seeking fast turnaround times, and both tests have already received Ministry of Food and Drug Safety (MFDS, formerly known as the Korea Food & Drug Administration or KFDA) approval in South Korea. Todos will be assisting in obtaining Emergency Use Authorization (EUA) for each of these molecular tests with the U.S. FDA. 

'The addition of the rapid POC Antigen test to improve molecular screening availability and the rapid POC PCR test to dramatically improve confirmatory turnaround times for key at-risk populations, such as skilled nursing facilities, is incredibly important for Todos as we continue the development of total testing solutions for the U.S. market,' said Dr. Jorge Leon, consulting Chief Medical & Scientific Officer of Oncology and Infectious Disease for Todos. 'Being able to offer increasingly sophisticated clientele access to every key technology available for SARS-CoV-2 diagnosis and screening is critical as we continue to build our position as a leader in COVID-19 testing in the U.S. We are developing the necessary protocols to make meaningful testing gains, which must be rooted in test accuracy as well as fast turnaround times. Rapid POC tests are a critical tool to help facilitate the expansion of meaningful testing results.'

The Rapid Antigen test runs on a proprietary FIA machine and allows reading of results within 10 minutes of sample collection. The Rapid PCR test runs on a proprietary POC PCR machine and allows for results within 40 minutes of sample collection. The purpose of using these tests in combination is to allow for POC screening with the Rapid Antigen test, and if a positive is found, to utilize the Rapid PCR test to confirm whether the result is a true positive or whether it is due to a prior infection. This is critical for risk mitigation and decision-making purposes.

The Rapid Antigen test has demonstrated sensitivity of 86.49% and specificity of 97.87%, whereas the Rapid PCR test has demonstrated sensitivity of 100% and specificity of 100%. Todos will have access to approximately 1 million rapid POC Antigen tests per week and 1 million rapid POC PCR tests per week upon the tests being granted EUA.

'The continued expansion of product portfolio is a very exciting development as we expand our product offering for stakeholders needing testing in the United States,' said Gerald Commissiong, CEO of Todos Medical. 'We are excited to fill the molecular point of care aspect of our COVID testing pipeline as we await data from our proprietary 5 minutes saliva 3C protease test.'

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

For testing and PPE inquiries, please email [email protected]

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. 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.

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. In July 2020, Todos completed the acquired Breakthrough Diagnostics, Inc., the owner of the LymPro Test intellectual property, from Amarantus Bioscience Holdings, Inc. (OTC: AMBS).

Additionally, 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. Todos has formed strategic partnerships with Meridian Health, Moto-Para Foundation to deploy COVID-19 testing in the United States.

For more information, please visit https://www.todosmedical.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=v1kJOGklsfM

Aytu BioScience, Inc. (NASDAQ: AYTU) announced last month that the Company has signed a distribution agreement with Apollo Med Innovations, Inc. to distribute the COVID-19 IgG/IgM Rapid Test Cassette to Apollo's network of over 1,000 practices across the United States. This distribution relationship expands the Company's coverage of clinician and professional customers to a large network of medical clinics, clinical laboratories, and wellness centers. Apollo is also engaged with a growing number of employers and municipalities in offering their COVID-19 testing services. Through Apollo's introduction of innovative research-based COVID-19 testing protocols and their offering of comprehensive laboratory support services, this distribution relationship significantly expands the Company's COVID-19 potential user base.

CytoDyn Inc. (OTCQB: CYDY) announced last week an independent Data Safety Monitoring Committee ("DSMC") completed its first safety review of the ongoing Phase 3 clinical trial (CD12) in patients with severe and critical COVID-19 and reported it saw no cause to modify the study. The DSMC reviewed compiled safety data from 149 subjects enrolled in the CD12 trial. The DSMC did not raise any concerns regarding safety and recommended that the trial continue. The Phase 3 study currently has 169 enrolled patients and the Company will conduct a full interim analysis once 195 patients are enrolled, as provided in the trial's protocol. Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, "We thank the DSMC for its diligence, guidance and support. We are grateful to be less than 30 patients away from our planned interim analysis enrollment goal, and we look forward to sharing those interim efficacy results as soon as possible."

iBio, Inc. (NYSE: IBIO) announced last week an update on one of its proprietary vaccine candidates being designed to prevent infection from the SARS-CoV-2 virus. iBio is investigating an array of adjuvants in combination with iBio's proprietary lichenase carrier molecule ("LicKMTM") fused to a coronavirus subunit protein ("IBIO-201") with the goal of producing a safe and effective vaccine for COVID-19 disease, and especially one for our most vulnerable populations, including the elderly. Ten distinct preclinical study arms for the IBIO-201 antigen-adjuvant combinations have been concluded.  These include combinations delivered via intramuscular and intranasal routes, and datasets are under evaluation. "We are encouraged by these pre-clinical data, which demonstrate IBIO-201's ability to generate an immune response to SARS-CoV-2 sequences and neutralize protein interaction," said Tom Isett, Chairman & CEO of iBio. "We expect to gain more insight as we complete data analysis of both of our COVID-19 vaccine candidates."

Pfizer Inc. (NASDAQ: PFE) announced earlier this month a multi-year agreement with Gilead Sciences, Inc. to manufacture and supply Gilead's investigational antiviral remdesivir, as one of multiple external manufacturing organizations supporting efforts to scale up supply of the investigational treatment for COVID-19. Under the terms of the agreement, Pfizer will provide contract manufacturing services at Pfizer's McPherson, Kansas facility to manufacture and supply remdesivir for Gilead. "From the beginning it was clear that no one company or innovation would be able to bring an end to the COVID-19 crisis. Pfizer's agreement with Gilead is an excellent example of members of the innovation ecosystem working together to deliver medical solutions," said Albert Bourla, Chairman and Chief Executive Officer. "Together, we are more powerful than alone. As one of the largest manufacturers of vaccines, biologics and sterile injectables, it is a privilege to offer our expertise and infrastructure to help fight this pandemic. In that spirit, we are pleased that Gilead is using our manufacturing capacity to help facilitate supply of this medicine to patients as quickly as possible."

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