i-Diagnostics and TIRF Analytix – technologies empowering Apollo Program for Biodefense

     In September 2020, soon after the wake-up call of COVID-19, the Bipartisan Commission on Biodefense published a report entitled Diagnostics for Biodefense – Flying Blind with No Plan to Land. The front-line of biodefense in the US was totally unprepared for the pandemic. In 2010-2014 there was a cohort of biosecurity experts who urged the US government to implement efficient preparations for anticipated pandemic, including the development of efficient diagnostics, which should be rapidly enrollable, robust, accurate and available at the point-of-need, including first-responders and home-use.  TIRF Labs is fortunate to be uniquely-well positioned in the area of molecular diagnostics and our way to give back to society is to create two clusters of open source platforms that meet the requirements of biodefense. The platforms are based on our technologies TIRF Analytix and i-Diagnostics. TIRF Analytix platform, if available for ~20,000 research groups worldwide, will create a global infrastructure of precision medicine and enable swift localization of outbreaks, rapid drug screening for early treatment via re-purposing of FDA-approved drugs for prophylactics and treatment of emerging diseases.

    We believe that for rapidly mutating pathogens re-purposing of previously FDA-approved drugs -off-label use of medicine for prophylactics and early treatment is an efficient way to prevent emerging pandemics. Several research groups worldwide have already used our TIRF Analytix platform for single molecule biology mechanistic studies, drug discovery, as well as for rapid molecular diagnostics.

     We envision that price-efficient TIRF Analytix will be available to all research groups worldwide and affordable i-Diagnostics devices will be available to general public. The US Government has granted $4.3M for Phase I of our project. We are ready to move to Phase II to make the preventative precision diagnostics available for all. We have supplied TIRF Analytix products and i-Diagnostics prototypes to several laboratories in the U.S. and abroad. We pledge to make TIRF Analytix and i-Diagnostics open source platforms suitable for a global infrastructure of precision medicine so that accurate diagnostics will be available to everyone.

    Soon after the outbreak of Corona virus and the emergence of COVID-19 epidemic, our TIRF Analytix customers discovered new, anti-COVID-19 functions of a dozen of previously FDA-approved drugs, including Hydroxychloroquine, Fenofibrate, and Ivermectin; the latter being the champion due to its exceptionally low toxicity. Paradoxically, the low cost of Ivermectin turned to be the greatest obstacle of using it in the U.S. and other industrialized countries.

   The North India state Uttar Pradesh of 231 million people eradicated COVID-19 with Ivermectin treatment program, representing one of the greatest public health achievements in history. It was kept a global secret. We welcome you to share your data, opinions and ideas about emerging and propagating pandemics.

     The COVID-19 crisis has demonstrated that we need a global infrastructure, which would help to prevent, localize and combat pandemics. TIRF Labs’ team is committed to make accurate diagnostics available to everyone. Scientific and technological capabilities for efficient management of pandemics already exist.

    In the beginning of COVID-19 scientists and medical professionals have outlined the necessary measures in the Great Barrington Declaration and in the Open Letter of Belgian Medical Doctors. The same or similar measures and approaches apply to future pandemics. In 2019-2020 our customers used our TIRF microarray technology to discover and re-purpose FDA-approved drugs to prevent and cure COVID-19. Dozens of re-purposed drugs have been found to be efficient for prophylactics and early treatment of COVID19, including Ivermectin, Fenofibrate, and Hydroxychloroquine. Ivermectin is less toxic than aspirin and appears to be the absolute champion – the global solution for COVID-19, most of other RNA viruses, some of DNA viruses, and certain types of cancer. It is also efficient against Tuberculosis, some other microbial pathogens, inflammation, etc.

     Ivermectin was discovered in the late 1970s. In 2015 The Nobel Prize in Physiology or Medicine was awarded to Drs. William C. Campbell and Satoshi Ōmura for their discoveries of Ivermectin. Unfortunately, there is a large gap between science, mass media and decision-making politicians. Safety of biological materials for human use, including vaccines and drugs, must be the highest priority in all circumstances. If adverse side-effects and multiple deaths are reported, the biological material must be removed from the market, without any delay.

     Vaccines vs. Re-purposing Existing Medicine. The development of new vaccines, even if the pathogen does not mutate, in principle, cannot be fast. Typically, it takes several years to prove that the potential vaccine is efficient and the benefits overwhelmingly exceed adverse side effects. Make a note that we are talking so far about short-term side-effects. Long-term side effects of genetic materials injected into human body are impossible to predict during several years of use. Therefore, alternative approach – re-purposing of previously approved drugs (approved for other purposes) off-label use to prevent new pandemics or/and combat new pathogens – appears to be a productive approach. It has proven its efficiency in numerous instances over several decades. In the beginning of COVID-19 pandemic dozens of FDA-approved drugs have been found efficient for prophylactics and treatment of COVID-19.

     Ivermectin, a potent a potent antiparasitic agent was found to be efficient for for prophylaxis and early treatment of COVID-19, as well as most of other RNA viruses, some DNA viruses, and even bacterial infections. The State of Nebraska was the first U.S. state, which approved Ivermectin as COVID-19 treatment. Dr. Ben Carson showed that despite the lack of so-called “gold standard” double-blind studies, we now effectively know that early off-label use of the anti-parasite drug Ivermectin can have a significant effect on reducing COVID mortality — especially when used in conjunction with other substances like azithromycin, zinc, and Vitamin D.

     Running a double-blind study requires large amount of funds — the kind of money that only a new, patented drug–maker could afford, in hopes of selling a high-priced remedy to millions of consumers. Repurposing off-patent drugs like Ivermectin does not yield the kind of profits that would be necessary to pay back the cost of double-blind studies. On the other hand, staggering ~1,000% return on investment in the area of mRNA vaxxassination resulted in numerous abuses in approvals and marketing of harmful mRNA jabs sold under deceitful name of “vaccines”. So this appears to be the main obstacle for using safe and efficient Nobel-Prize-awarded inexpensive substance – Ivermectin.