Spread of New Variant Reinforces the Need for Comprehensive Diagnostics

Concerns begin to resurface as the Omicron variant has proven to be a highly contagious continuation of the pandemic. In fact, the number of new cases in the United States over the last 30 days has exceeded 3 million. Nevertheless, World Health Organization officials have criticized blanket Covid-19 vaccine booster programs as poor countries struggle to obtain initial doses, warning that the unequal access to immunizations could lead to more mutated variants that drags out the crisis further. "Blanket booster programs are likely to prolong the pandemic, rather than ending it, by diverting supply to countries that already have high levels of vaccination coverage, giving the virus more opportunity to spread and mutate," WHO Director-General Tedros Adhanom Ghebreyesus said during a news briefing. Todos Medical Ltd. (OTC: TOMDF), Pfizer Inc. (NYSE: PFE), Johnson & Johnson (NYSE: JNJ), Vaxart, Inc. (NASDAQ: VXRT), Hologic, Inc. (NASDAQ: HOLX)

Even though vaccines are readily available and are being rolled out around the globe, 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 yesterday breaking news that, "its highly automated CLIA/CAP PCR and cPass neutralizing antibody COVID-19 testing laboratory Provista Diagnostics has entered into a reference laboratory services agreement with a Kentucky-based physician group with practices in over 40 states that focuses on blending the benefits of old fashioned medicine and modern healthcare, with a goal of providing "concierge for everyone" (the "Physicians Group"). This reference lab agreement covers the semi-quantitative cPass neutralizing antibody test that recently expanded upon its Emergency Use Authorization with the addition of semi-quantitative titer claims to be able to measure convalescent neutralization activity and provide a score to monitor over time.

In addition, Provista has completed the validation for a fingerprick At-Home sample collection device for the cPass neutralizing antibody test. The Company expects to launch a direct-to-consumer self-collection At-Home cPass neutralizing antibody test to enable people to monitor titers from the comfort of their own homes in the very near future.

'We are very pleased to be winning laboratory service contracts for Provista with cPass because we see the value of this test, especially in light of the highly contagious Omicron variant that demands much higher titers of neutralizing antibodies to achieve neutralization activity,' said Gerald E. Commissiong, President & CEO of Todos Medical. 'Given waning immunity with existing vaccines that require boosters to be taken timely, or risk susceptibility to infection with Omicron, we expect to continue to gain in popularity as we move forward. With the addition of fingerprick At-Home cPass testing, we can make it very convenient to help patients test and monitor their neutralizing antibody titers which we believe should substantially increase the market opportunity for this important test.'

For more information on Provista's parent company Todos Medical, please visit www.todosmedical.com. For more information on Provista Diagnostics' CLIA/CAP certified lab please visit www.provistadx.com."

Pfizer Inc. (NYSE: PFE) announced yesterday that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The treatment includes nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer's laboratories, which was specifically designed to block the activity of the SARS-CoV-2 Mpro, an enzyme that the coronavirus needs to replicate. "Today's authorization of PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world. This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Pfizer stands ready to begin delivery in the U.S. immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible."

Johnson & Johnson (NYSE: JNJ) reported earlier last week that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion for use of the Company's COVID-19 vaccine as a booster for adults aged 18 and older at least two months after primary vaccination with a single-shot of the Johnson & Johnson COVID-19 vaccine, and as a 'mix and match' booster following primary vaccination with an approved two-shot mRNA COVID-19 vaccine regimen (known as heterologous boosting). "We are pleased with today's Positive Opinion from the CHMP supporting the use of our COVID-19 vaccine as a booster for eligible individuals in Europe," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "There is a growing body of data showing that the Johnson & Johnson COVID-19 vaccine induces broad and durable humoral and cellular immune responses, whether administered as a single shot for an efficient response to the pandemic, or as a booster shot after at least two months to strengthen protection against symptomatic COVID-19. Cellular immune responses are showing potential to be important for both breadth of protection and durability."

Vaxart, Inc. (NASDAQ: VXRT) explained last week that it plans to test the cross-reactivity of its oral tablet COVID-19 vaccine candidate against the Omicron SARS-CoV-2 variant in two different studies expected to begin next month. In the first study, Vaxart will test the activity of its Phase II COVID-19 oral vaccine candidate against Omicron by analyzing mucosal and serum samples from subjects to whom the vaccine was administered in Vaxart's current COVID-19 vaccine Phase II trials, Dr. Sean Tucker, Vaxart's Chief Scientific Officer and founder, said. In the second study, Vaxart will conduct an animal Omicron challenge study to assess how its current Phase II COVID-19 vaccine candidate performs in comparison to an Omicron-specific vaccine candidate that Vaxart is developing, Dr. Tucker said.

Hologic, Inc. (NASDAQ: HOLX) reported last month that its three SARS-CoV-2 tests all detect the recently emerged Omicron variant of the coronavirus that causes COVID-19. Initially identified in South Africa and subsequently in a number of African, European and North American countries, the Omicron variant (B.1.1.529) contains approximately 30 mutations. Hologic conducted an analysis of genetic sequences from more than 175 Omicron-infected samples obtained through GISAID (Global Initiative On Sharing All Influenza Data, https://www.gisaid.org/) and determined that none of the new mutations occur within regions of the genome targeted by Hologic's Aptima® SARS-CoV-2 Assay, Aptima® SARS-CoV-2/Flu Assay or Panther Fusion® SARS-CoV-2 Assay. Hologic has also received data from clinical users in Europe indicating that the Aptima SARS-CoV-2 assay detected Omicron COVID-19 infections in samples from inbound air travelers.

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