Effective Diagnostics Help to Tame the Spread of the Pandemic

NEW YORK, March 24, 2021 /PRNewswire/ -- Recent reports from across the country clearly show that infection cases are stabilizing. Additionally, vaccines are being administrated at an effective rate, which contributes to a more relaxed attituded towards the pandemic. As a result, the economy continues to slowly open up. However, concerns over the virus remain, especially in regards to the new virus variants. For example, infection rates and hospitalizations are rising again across the New York state, with New York City still wrestling with more contagious variants of the virus, Gov. Cuomo said on Tuesday, according to the New York Daily News. "We're working toward a future in which COVID is left behind and we can settle into the new normal," Cuomo said in a statement. "(But) we have a ways to go until that happens." Todos Medical Ltd. TOMDF, BioNTech SE BNTX, Dynavax Technologies Corporation DVAX, Vir Biotechnology, Inc. VIR, Vaxart, Inc. VXRT

In the meantime, mass testing is crucial for governments to properly implement preventive measures throughout this pandemic. For example, in January, McSwain Union Elementary School in Northern California started testing teachers and then students for the virus, even if they weren't showing symptoms. According to a report by USA Today, "since then, regular, rapid antigen testing has caught five positive cases of staff members and one positive student who were either pre-symptomatic or asymptomatic, said Superintendent Roy Mendiola. Those people and their close contacts were immediately sent home, but everyone else could stay in school." As part of the push of the current administration to reopen schools, it has announced this week that it would make USD 10 Billion available for K-12 schools to expand screening of staff and students.

Todos Medical Ltd. TOMDF announced yesterday breaking news that, "it has entered into an automation and reagent supply agreement with MAJL Diagnostics ("MAJL"). Under the terms of the agreement, Todos will implement its automation solution, including Tecan™ liquid handlers, automated RNA extraction machines, as well as a 384-well PCR machine capable of conducting COVID, cancer genetics and pharmacogenomics testing, in order to become the provider of all COVID-19 PCR testing reagents and supplies. Upon completion of the automation process, MAJL will be capable of processing approximately 1,500 PCR COVID-19 tests per day.

'We are very excited to work with MAJL as they look to increase their capacity for COVID-19 testing and we continue to expand the geographic footprint of our install-base,' said Gerald E. Commissiong, President & CEO of Todos. 'Our automation solution will enable MAJL to scale their testing capacity significantly and give them the ability to actively engage with larger business opportunities, including school districts in the Atlanta area. As MAJL increases its testing capacity, we look forward to helping with their growth, providing additional automation as needed.'

'We were very impressed with the system Todos has been able to put together,' said Lisa Cloud, President & CEO of MAJL Diagnostics. 'We look forward to growing our COVID-19 PCR testing business in the months ahead and believe Todos' scalable solution provides us with the flexibility to expand our capabilities proportionately with our marketing efforts.'

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

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BioNTech SE BNTX together with Pfizer Inc. announced last month that the first participants have been dosed in a global Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in preventing COVID-19 in healthy pregnant women 18 years of age and older. "We are proud to start this study in pregnant women and continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations," said William Gruber M.D., Senior Vice President of Vaccine Clinical Research and Development, Pfizer. "Pregnant women have an increased risk of complications and developing severe COVID-19, which is why it is critical that we develop a vaccine that is safe and effective for this population. We are deeply thankful to the volunteers who are enrolling in the trial, and site investigators who are leading this work."

Dynavax Technologies Corporation DVAX and the Coalition for Epidemic Preparedness Innovations (CEPI) announced last month that they have entered into an agreement to support the supply of Dynavax's CpG 1018 advanced adjuvant to be used in approved COVID-19 vaccines developed by CEPI grantees. Dr. Richard Hatchett, CEO of CEPI commented: "A critical goal of CEPI's response to COVID-19 is to support development, manufacturing and distribution of vaccines to end the acute phase of the pandemic by the end of 2021. Through our partnership with Dynavax, we hope to enable the development and faster supply of adjuvanted COVID-19 vaccines and ensure equitable access to them globally."

Vir Biotechnology, Inc. VIR and GlaxoSmithKline plc GSK provided back in March an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. The companies were informed that while VIR-7831 met initial pre-specified criteria to continue to the next phase of the ACTIV-3 trial and there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit. The independent Data and Safety Monitoring Board (DSMB) has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature. The companies will continue discussions with the NIH about appropriate ways to further assess the potential of VIR-7831 in the hospitalized population as all parties gain a fuller understanding of the still-emerging data. The DSMB recommendation was based on a routine, pre-planned safety and efficacy data review of the first 300 patients hospitalized with COVID-19 enrolled in ACTIV-3.

Vaxart, Inc. VXRT announced last month preliminary data from its Phase 1 study of VXA-CoV2-1 showing that its oral COVID-19 tablet vaccine candidate was generally well-tolerated, and immunogenic as measured by multiple markers of immune response to SARS-CoV-2 antigens. "Our Phase I results highlight the importance of our differentiated vaccine design, as they suggest VXA-CoV2-1 could have broad activity against existing and future coronavirus strains. These results are timely, as we are seeing the emergence of new variants less responsive to first generation vaccines, thus making potential cross-reactivity another important advantage of next-generation vaccines," said Andrei Floroiu, Vaxart's Chief Executive Officer.

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