Diagnostic Improvements Play a Key Role in the Abatement of the Pandemic

NEW YORK, March 23, 2021 /PRNewswire/ -- Since the pandemic's inception and the subsequent pressure the healthcare infrastructure faced, effective mass testing has been necessary to come up with a proper plan to reduce case numbers. As a result, various companies from a vast field of industries, including biotechs, medical device manufacturers, tech conglomerates and others have all made various announcements of products or services related to the pandemic, with testing kits playing a key role. Developments have been made in the testing segment, as diagnostic testing has improved over the course of the last several months. By test type, the rapid antigen test held a substantial market share in 2020. Antigen assays are also usually more cost-effective when compared to either molecular or culture techniques. And, overall, the global rapid test kit market for the viral pandemic is expected to reach USD 3.91 Billion by 2027, according to a new report by Reports and Data. Todos Medical Ltd. TOMDF, Sorrento Therapeutics, Inc. SRNE, Vaxart, Inc. VXRT, Abbott Laboratories ABT, OPKO Health, Inc. OPK

Now that vaccines are available and are being rolled out, the worries of the pandemic are slightly receding. Yet, testing remains a crucial factor. Experts say that people who exhibit symptoms consistent with the infection, such as cough, fever, congestion, fatigue, headache or loss of sense of smell should get tested even if they have been vaccinated or previously had been diagnosed with the virus. Ahmad Gaber, Chief Executive Officer of Wellhealth and founder of GoGetTested, explained according to Healthline that "testing is important for two reasons. It warns the individual person, and it provides surveillance that allows us to find out what we can do about the disease from a public health perspective."

Todos Medical Ltd. TOMDF announced a corporate update last week, "following the achievement of certain key sales and financial milestones.

'The second half of 2020 and the beginning of 2021 has been an incredibly exciting time for Todos,' said Gerald E. Commissiong, President & CEO for Todos Medical. 'We took on the significant task of commercializing a new lab testing business with uncertain international supply chains and stiff competition, and we were able to carve out a niche of being able to timely provide labs with comprehensive lab-based COVID testing solutions that can scale to meet the requirements of local, state and federal contracting demands. Our focus on automation has created a commercial infrastructure able to deploy integrated solutions for labs looking to scale lab services for their core clients, and we believe the growing need for regional lab solutions in the United States will only make Todos' turnkey solutions more attractive to existing and prospective clients.'

PCR COVID Lab Testing Business

The PCR COVID lab testing business is currently undergoing a rapid transformation, as the US begins to move toward serial testing programs to further reopen the economy and a return to in-person education for children. This places labs that were unable to automate testing processes at a severe competitive disadvantage in acquiring new clients as well meeting increasing demands for faster turnaround times from payers. The only solution to this growing problem is to automate lab PCR testing processes in order to improve efficiency and scale. Given Todos' position of enabling labs to cost-effectively scale capacity in order to meet these new requirements for optimal reimbursement, we are now able to focus our new client acquisition strategy on those clients with strong demand from pre-existing and emerging relationships for COVID testing. We believe this will allow Todos to springboard our offering beyond PCR COVID Testing into new areas of molecular testing that are enabled by the automation Todos provides, and we intend to stay on the cutting edge of actionable tests with strong clinical utility that will enable physicians to provide improved patient outcomes with a lower overall cost of care.

Additionally, the Company is preparing to expand its offering into genomic sequencing in order to position its clients as Centers of Excellence in COVID testing, able to quickly reflex test confirmed PCR positive patients for variant determination. This capability will become increasingly important, especially as new variants emerge and as infected vaccinated individuals continue to spread the virus leading to evolutionary pressures to produce variants that will overcome current traditional receptor binding domain (RBD) antibodies. While the current focus is on the B.117 variant originally identified in the UK, the more troubling variants are those that seem to be able to evade existing vaccine immune response, such as the B.135 variant originally identified in South Africa. New variants have been discovered in New York City, California and most recently in Brittany, France, and we expect the proliferation of new variants to become an emerging theme as the pandemic enters a new phase alongside state-sponsored mass vaccination plans globally. The ability of high-capacity labs to become regional reference labs for COVID variant surveillance will become paramount as economies re-open, social interactions increase dramatically and domestic and international travel re-emerge as a normal way of life.

Further, Todos has made significant investments in helping to develop a novel mobile biosafety level 3 molecular laboratory infrastructure capable of doing high capacity (3,000+ tests/day) housed in a 20-foot container, able to be deployed anywhere in the world. This product offering was recently featured in the Wall Street Journal. We intend to focus on initially deploying in the New York City area before scaling deployment to other areas and we are working with prospective partners to bring this forward. This will allow for 6h or less turnaround times that will be suitable to cater to sporting events, theatre shows, international travel, nightlife, as well as several other industries where impulse decision making is critical for business. Whereas most 'mobile labs' really are sample collection sites that then have to send specimens for PCR testing at traditional brick and mortar labs, Todos' solution actually performs that PCR testing on-site, thereby dramatically cutting down logistical issues that lengthen the reporting of results.

Todos intends to leverage its position in helping to build regional Centers of Excellence in COVID testing by focusing on monitoring of 'long-hauler' COVID patients and building testing menus that cater to the emerging areas of concern that could become more important for patient stratification and monitoring. These areas include hereditary cancer (CGx) testing combined with actionable biomarker monitoring where Todos has significant IP, including Todos' TBIA platform and our pending acquisition of Provista Diagnostics for its Videssa Breast Cancer screening test, pharmacogenomic (PGx) testing designed to improve pharmaceutical prescribing success by improving patient outcomes as well as dementia screening, where Todos has intellectual property surrounding the LymPro Test™, a novel biomarker test monitoring cell cycle checkpoint integrity that drives the inappropriate attempts at cell division by post-mitotic neurons, a potentially actionable therapeutic target in Alzheimer's disease.

Todos intends to focus on ways to leverage its existing testing business and its client base to deliver actionable high value testing that will improve outcomes while lowering cost of care.

3CL Protease Biology and Commercial Opportunities

Since the beginning of the pandemic, the primary focus of public health efforts has been on the development of vaccines in order to facilitate the process of creating herd immunity among the population. To date, this has led to major scientific achievements with several novel vaccines being granted emergency use by national and international regulatory authorities and the initiation of a mass vaccination campaign that is racing against the spread of potential new variants able to escape these vaccines' immunological signature. With that said, one of the areas where significantly less progress has been made is in the area of antivirals, where new products aim to cripple the virus' ability to replicate and thus provide the body with more time to mount an innate and/or acquired immune response…"

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Sorrento Therapeutics, Inc. SRNE announced earlier this month major progress in the development of COVISHIELD through the license of intellectual property developed by the scientific team at the Icahn School of Medicine at Mount Sinai ("Mount Sinai"). Sorrento and Mount Sinai have entered into an Exclusive License Agreement for a collection of antibodies having SARS-CoV-2 neutralizing properties that were developed by Mount Sinai. The license also contemplates Sorrento and Mount Sinai pursuing future collaborations in developing humanized monoclonal antibodies for therapeutic applications. Sorrento Chairman and CEO, Dr. Henry Ji, commented, "We are pleased with the excellent COVISHIELD antibody candidates identified thus far, and we at Sorrento are committed to rapidly developing the COVISHIELD cocktail against known and emerging COVID-19 variants of concern. Sorrento looks forward to future collaborations with the respected research capabilities of Mount Sinai centered on the development of innovative anti-viral and anti-cancer therapeutic candidates."

Vaxart, Inc. VXRT announced last month that it plans to initiate the first Phase 2 study of its oral COVID-19 vaccine candidate, VXA-CoV2-1, in 2Q 2021. Vaxart made this announcement as it provided financial results for the fourth quarter and full year ended December 31st, 2020 and provided a corporate update. "Recently, we have seen the emergence of new SARS-CoV-2 strains, against which some of the leading injectable vaccines offer reduced protection. At the same time, it has become clear that mass vaccinations by needle take a long time, and new strains may emerge faster than many countries' medical and governmental infrastructure can inject their populations. A better solution is needed given that COVID-19 may be a challenge for years to come," said Andrei Floroiu, Chief Executive Officer of Vaxart. "As a result of our scientists' foresight to include both the S and N proteins, VXA-CoV2-1 could be protective against these newly emerging variant strains. We are very excited about the prospect of moving into Phase 2 not only as an oral COVID-19 vaccine candidate, but one with a differentiated mechanism, which could prove to be valuable globally in the fight against coronavirus."

Abbott Laboratories 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."

OPKO Health, Inc. OPK announced back in October the beginning of its COVID-19 testing program for New York City schools throughout the 2020-2021 school year to help ensure a safer school environment. Continuing a strategic collaboration with New York City, the Department of Health, New York City Health and Hospital Corporation (NYC Health + Hospitals), the Test & Trace Corp, and the Department of Education, BioReference is performing COVID-19 molecular testing for NYC schools. In addition, BioReference is collecting specimens from principals, teachers, administration and students from over 950 schools across NYC. "This school year for New York City and other school systems around the world is vastly different due to the global pandemic, and BioReference is privileged to aid in keeping NYC schools safe," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories.

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