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i-Diagnostics

Open Source Platform for Global Infrastructure of

Precision Medicine for Preventing New Pandemics

and Minimizing Damage from Existing Diseases

i-Diagnostics and TIRF Analytix for Biodefense   

 In 2021 Bipartisan Commission on Biodefense published Apollo for Biodefense Program and in 2024 supplemented the Program with elaborated National Blueprint for Biodefense. These documents propose to make the impossible - possible: prevent future pandemics and minimize the damage from existing diseases. The Blueprint encompasses 36 recommendations and 185 actions that are necessary for preventing pandemics. One of the pillars for the Biodefense program is diagnostics for point-of-need applications. Another critical pillar includes biodefense analytical instrumentation for laboratory settings.  TIRF Labs' team has developed necessary technologies and is excited to become a part of the Program. We envision that TIRF Analytix and i-Diagnostics will become core technologies empowering the Apollo For Biodefense Program in several areas, including diagnosing and countermeasures development. Alternative approaches are either inaccurate, slow, or prohibitively costly. 

     Currently, TIRF Labs performs non-profit project – i-Diagnostics by chipping a part of our modest commercial income to advance i-Diagnostics to the market. Our efforts are in line with the goal of paramount importance - to minimize the probability of humanity eradication, prevent pandemics and minimize the damage from existing diseases. We envision that a global infrastructure will be created based on two clusters of open-source platform technologies: TIRF Analytix and i-Diagnostics. The former cluster includes TIRF microscopy for single molecule biology, TIRF microarrays for drug screening, and laboratory-based mega-diagnostics; the latter – i-Diagnostics gadgets for home-use and first-responder applications. The envisioned infrastructure will facilitate localization and confinement of emerging infections and enable efficient combating existing and emerging diseases.

     TIRF Labs’ team is uniquely positioned in the area of molecular diagnostics. After 9-11 and anthrax letter attacks, the U.S. Government funded Phase 1 of our R&D efforts in application to CBRNE security. We exceeded the expectations for R&D grant outcomes and not only invented and prototyped, but also manufactured and supplied to multiple research groups worldwide our innovative products TIRF Analytix and prototypes of i-Diagnostics. We don’t use standard marketing and rely on the ‘word-of-mouth’ of our customers, who publish their studies in scientific journals. We haven’t reached massive manufacturing yet, but generate enough income to chip a part of it for our non-profit endeavor i-Diagnostics.

     This is our way to give back to society. Our progress, however, was slow, while Corona and other microbes mutate fast. To accelerate global progress on prevention, we pledge to give back by creating an open source platform for global infrastructure of precision medicine, home-use diagnostics, longevity and rejuvenation studies. We envision that i-Diagnostics will become affordable to everyone on the globe, while TIRF Analytix instruments will turn into industrial standards for clinical, academic and CBRNE security laboratories.

     We have successfully completed Phase 1, for which the US Government awarded $4.3M. To accelerate our progress, prevent future pandemics and minimize the damage from existing diseases, we inquire the U.S. Government for grants and philanthropists for donations to cover the development cost of Phase 2. If TIRF Analytix becomes available to all research groups worldwide and i-Diagnostics gadgets are affordable for all, preventing and localizing the outbreaks of infections and minimizing the damage from existing diseases will transfer the healthcare to qualitatively better level. We invite you to become a part of global efforts of preventing future pandemics. Apollo for Biodefense program will revolutionize medicine, enable rejuvenation for MAHA, improve quality and reduce the cost of healthcare. We believe that America is at the verge of new Golden Era. We envision that TIRF Analytix and i-Diagnostics will become indispensable tools for the great purpose of “Make America Healthy Again“, as well as for longevity and rejuvenation studies.

     Looking into remote future, we would be excited to become a part of SpaceX community and contribute to its mission of making humanity an interstellar species. Naturally occurring and man-made pathogens, as mentioned above, impose existential risks on humanity at the planet Earth, as well as in the Universe. Dr. John Sotos wrote: "... assuming that civilizations universally develop advanced biotechnology, before they become vigorous interstellar colonizers, the model provides a resolution to the Fermi paradox.” Addressing these challenges is equally important for preventing self-eradication on Earth as well as for interstellar civilization. TIRF Analytix and i-Diagnostics mitigate for the risks and, thus, are of paramount importance for both dimensions.

     TIRF Labs’ team is committed to make the TIRF Analytix available to every research group worldwide, and the i-Diagnostics – affordable for all. We envision that the i-Diagnostics project will create a global infrastructure supported by governments and end-users worldwide. COVID-19 pandemic demonstrated the necessity for such global infrastructure, which is capable of preventing the emergence of infections, localizing their outbreaks, and rapid development of countermeasures.

     While Elon Musk imagines raising humanity to 1 trillion to colonize the entire Solar system, infections appear to be the greatest challenge for humanity survival. To mitigate the risk, mankind requires an infrastructure based on a super-sensitive and highly multiplexed biodetection platform for laboratory studies, as well as accurate and rapid diagnostics for home-use and field applications by first-responders. Otherwise, it will be “…Flying blind with no plan to land.” TIRF Labs’ team of scientists and engineers has developed such platforms in Phase 1 of our project. We are ready to move to Phase 2 to make TIRF Analytix available to all researchers worldwide and i-Diagnostics – for all on the globe.

     We inquire The Giving Pledge members, other philanthropists, and the U.S. Government, including DARPA, BARDA, NIH, NSF, and DHS to support our non-profit project. We ask for new roles of The Giving Pledge and the U.S. Government, including DARPA and BARDA, in establishing new type of non-profit investments to mitigate the risks of humanity eradication. It is difficult, if not impossible to commercialize diagnostics and analytics for non-existing yet pathogen. But we can and must be prepared well to emergence of new pathogens. Technologically the goals of being prepared well for a new pandemic are already feasible. Several research groups worldwide have already acquired our TIRF Analytix instruments and  i-Diagnostics prototypes and have developed new applications. At the present time, TIRF Labs supplies TIRF Analytix as analytical-grade instruments. We received hundreds of requests, but only a few groups worldwide are currently using them, because of the cost. We pledge to refine TIRF Analytix to affordable, robust laboratory instruments and i-Diagnostics down to gadgets as simple for use as glucose monitoring devices. The status of Open Source Platforms will facilitate the creation of a global network of research groups that use TIRF Analytix, while i-Diagnostics gadgets will establish a social network based on healthcare applications. Numerous experts will develop their applications and create the envisioned infrastructure based on the intelligence of the global network of scientists, medical doctors, and end-users. NTIRF Labs is establishing an intelligence unit to coordinate these efforts. Donate to become a part of these global efforts of revolutionizing medicine, improving quality, and reducing the cost of healthcare. Make America Healthy Again, change the future of healthcare together with us to be always a step ahead of any disease. 

i-Diagnostics and TIRF Analytix Advantages

  • i-Diagnostics is built on TIRF Analytix detection platform capable of detecting single molecules, which is ultimate sensitivity.

  • i-Diagnostics uses enhanced 3D TIRF microarrays to minimize false-negative and false-positive responses to negligibly small levels. Alternative methods do not provide similar small levels of false-negative and false-positive responses.

  • i-Diagnostics microarrays detect 4 classes of biomarkers simultaneously: DNA, RNA, proteins, and metabolites, making it a mega-diagnostics device.

  • In 2013 the US Department of Defense highly ranked [1] our TIRF microarray devices versus alternative technologies.

  • In 2014-15 we extended our classical 2D TIRF microarrays into the 3rd dimension using silk fibroin and invented i-Diagnostics based on the TIRF microarray reader with cost below ~$100, and cartridges $1-10.

  • Rapid on-site detection with minimal sample preparation provides unique advantage of detecting short-lived bioanalytes that do not survive shipping and complex sample preparation.

  • The above listed set of advantages is not found in alternative technologies that are less sensitive, typically detect only one class of biomarkers, require labor-intense sample preparation, exhibit large rates of false positive and false negative responses, are not compact and cost-efficient.     

     i-Diagnostics uses the phenomenon of evanescent wave, which provides exceptional surface selectivity and enables TIRF with the ultimate limit of detection – down to single molecules. TIRF is capable of detecting a multitude of single molecules of different classes simultaneously, a feature not found in any other technology. Since TIRF detects fluorescence only from a sub-micron layer next to the surface, minimal-to-no sample preparation is necessary. Whole blood can be analyzed and the results can be obtained in a matter of minutes. We are not aware of other technology that could be as sensitive, accurate, and rapid, detects all four major classes of biomarkers, and yet is affordable. In the area of diagnostics, there is a consensus that an accurate diagnosis requires the simultaneous detection of several biomarkers, provided that the occurrence of those markers is not correlated. Such markers called "orthogonal" are independent of each other. Typically, for a single biomarker, the rate of false positive responses is ~10%. Assuming that this rate is 10%, for a panel of two orthogonal markers this rate decreases to 1%; for 3 markers, to 0.1%. i-Diagnostics is capable of detecting up to 40,000 molecular markers in parallel. However, in most practical applications, detecting more than 20 markers is seldom necessary.

Contact

TIRF Labs, Inc.

517 Willard Woods Dr., Wendell,

RTP area, North Carolina, USA

info@tirf-labs.com

Phone: +1.919.463.9545

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