Latest Spike in Cases Reiterates the Importance of Comprehensive Diagnostics

FinancialBuzz.com News Commentary

NEW YORK, July 20, 2021 /PRNewswire/ -- Concerns over the pandemic are once again in the forefront as the Delta strain has become the driving force of new COVID surge. Fears that a new wave may paralyze the economy once again has sent the Dow Jones tumbling more than 700 point on Monday, which is one of the worst single day declines of 2021. In New York, Governor Andrew Cuomo's office reported that the state's positive infection rate rose to 1.51%, up from 1.02% a week prior and 0.63% two weeks ago. "New Yorkers have fought COVID-19 every single step of the way during this pandemic, but there's one final push we have to make, and that's the need for everyone to get vaccinated," Governor Cuomo said in a statement, according to a report by Fox 5. "Getting shots in arms is key to our success against this terrible virus, and if you haven't gotten yours yet, I urge you to make an appointment or walk into one of the many sites we have across the state. Help yourself, your family and your community by getting your shot today." Todos Medical Ltd. (OTC: TOMDF), Pfizer Inc. (NYSE: PFE), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), Koninklijke Philips N.V. (NYSE: PHG), Hologic, Inc. (NASDAQ: HOLX)

Even though vaccines are available and are being rolled out, 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. (OTCQB: TOMDF) announced breaking news yesterday that, "it has entered into a distribution agreement with Fosun Pharma for the cPass™ SARS-CoV-2 Neutralizing Antibody Detection Kit* that has received Emergency Use Authorization ("EUA") from the US FDA for the detection of SARS-CoV-2 receptor binding domain ("RBD" or "neutralizing") antibodies. A recent peer-reviewed paper published in the scientific journal Nature Medicine concluded: "… Here, we show that neutralization level is highly predictive of immune protection, and provide an evidence-based model of SARS-CoV-2 immune protection that will assist in developing vaccine strategies to control the future trajectory of the pandemic."

"With the Delta variant posing a significant risk for breakthrough infections based on data from Israel, and fears increasing of a potential third wave nationwide, we see neutralizing antibody testing becoming critical for informed decision making to assess who may be best suited for booster shots, as well as at what point someone previously infected with COVID begins to show waning immunity and may decide to receive vaccination as a result," said Jorge Leon, Chief Medical Officer for Immunology and Oncology at Todos. "As we begin to learn more about the heterogeneity of immune response to different COVID vaccines, there appear to be subgroups of people who may need an additional dose of the vaccine to be considered fully vaccinated from a neutralizing antibody perspective, and we have now seen the Ministry of Health in Israel just this past week begin to give booster shots to the immunocompromised and certain other at-risk groups who were shown to have low neutralizing antibody titers. Additionally, a recent German study reported that 2% of the general population and over 30% of those over 80 had no detectable neutralizing antibody levels after their second vaccine dose. The cPass test will enable individuals to take charge of their health by making data-driven decisions to protect themselves beyond vaccination, such as masking or avoiding certain higher-risk activities when armed with this crucial information."

Todos sees a large market opportunity developing for cPass that will begin to encroach on the COVID-19 PCR testing market that rapidly developed into an $80 billion market worldwide in 2020. We believe immune monitoring will be the primary driver of COVID-19 testing growth going forward. To date, 161 million people in the United States have been vaccinated, with the majority of the doses having been administered to older populations who are most likely to show waning immunity the earliest, and will be the first ones for whom booster decisions will have to be made. As time advances, and more and more individuals are 6 months and beyond from their initial vaccine dose, it will become increasingly important for individuals and healthcare providers to asses and monitor neutralizing antibody levels in order to make data-driven decisions with respect to booster shots and behavioral changes.

The Company is currently automating the EUA cPass test at its CLIA/CAP laboratory, Provista Diagnostics ("Provista"), to add high-capacity neutralizing antibody testing to its test menu, and is ramping up its sales and marketing infrastructure. Provista plans to offer cPass as a testing service to other CLIA labs on a reference basis, as well as directly to the public through healthcare professionals. A key differentiator for this novel cPass test is that it detects neutralizing antibodies in patient samples without the use of live virus and with very fast turnaround times, as compared to the conventional method of measuring neutralizing antibodies in patient samples, which requires the use of live cells. Upon completing the automation process, Todos expects Provista to provide high volume results in less than 24 hours. Todos will also make cPass available for client labs to run on their automated equipment.

Todos has also been granted authorization to utilize a high value version of the cPass test at Provista that has been adapted to quantitate neutralizing antibody levels, thereby allowing monitoring of levels over time. Todos sees this modified test as eligible for a higher reimbursement rate than traditional SARS-CoV-2 antibody tests. The Company intends to aggressively market Provista's new testing capabilities in the coming months in order to begin to capitalize on its investment in automation and drive high margin revenue growth.

* This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the presence of total neutralizing antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner."

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Pfizer Inc. (NYSE: PFE) announced back in June plans to provide the U.S. government at a not-for-profit price 500 million doses of the companies' COVID-19 vaccine, 200 million doses in 2021 and 300 million doses in the first half of 2022, to further support the multilateral efforts to address the surge of infection in many parts of the world and to help end the pandemic. The government will, in turn, donate the Pfizer-BioNTech vaccine doses to low- and lower middle-income countries and organizations that support them. "Our partnership with the U.S. government will help bring hundreds of millions of doses of our vaccine to the poorest countries around the world as quickly as possible. COVID-19 has impacted everyone, everywhere, and to win the battle against this pandemic, we must ensure expedited access to vaccines for all. I want to thank President Biden for his leadership in protecting the least advantaged of our global neighbors," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Fair and equitable distribution has been our North Star since Day One and we are proud to do our part to help vaccinate the world, a massive but an achievable undertaking."

Sorrento Therapeutics, Inc. (NASDAQ: SRNE) announced back in June that following its receipt of EUA approval from COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) under registration number "OFICIO: CAS/10720/2021", it is establishing a local "Sorrento Mexico Ltd" subsidiary to manage commercial operations in Mexico. COVI-STIX is a sensitive and rapid (approximately 15-minute) diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal or nasopharyngeal samples of patients ("Inmunoensayo de flujo lateral para la detección cualitativa de la proteína nucleocápside del SARS-CoV-2"). COFEPRIS issued Emergency Use Authorization (EUA) approval and an importation permit for COVI-STIX on June 14, 2021.

Koninklijke Philips N.V. (NYSE: PHG) announced earlier this March it has supported the NHS' Cheshire and Merseyside consortium [1] to become the first regional hub supplying the United Kingdom's National COVID-19 Chest Imaging Database (NCCID). The NCCID is a centralized database containing X-Ray, CT and MRI images from hospital patients across the country. It aims to support a better understanding of the COVID-19 virus and develop AI-powered technology which will enable the best care for patients hospitalized with a severe infection [2]. This first regional hub is integrating data across 13 NHS trusts in the consortium. The deployment of a single centralized and secure server has provided access to 15 years of imaging data across 2.5 million people in the region, the largest single data source for NCCID. "One of the findings coming out of the end of this project will definitely be to focus on regional hubs that will be able to coordinate and better centralize the data, a hub just like Cheshire and Merseyside," said Prof Mark-Halling Brown, Head of Scientific Computing at Royal Surrey NHS Foundation Trust. "It can take many months or even years to set up SMART boxes at individual trusts, so doing it regionally is the only way to scale up nationally."

Hologic, Inc. (NASDAQ: HOLX) reported last week that it has obtained a CE Mark for the use of saliva samples with the Aptima® SARS-CoV-2 assay in Europe. The Aptima SARS-CoV-2 test is a molecular diagnostic assay that detects the genetic material of the pathogen causing COVID-19. The test runs on the fully automated Panther® system. "This new CE Mark demonstrates our commitment to providing European consumers and healthcare providers as many options as possible to manage the ongoing pandemic," said Jan Verstreken, Hologic's group president, International. "While vaccination is helping stem the tide of COVID-19, we envision that testing will continue to play an important role, particularly in screening programs needed to reopen society."

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