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

​     TIRF Labs is offering, as mentioned above, the entire family of products, tools, cartridge blanks, sample preparation modules, reagents, supplies, methods and protocols, on-line and on-site technical support to facilitate all stages of innovations at i-Diagnostics platform. TIRF Labs’ role is to provide logistics and service support of these innovations and to shorten their way to FDA approvals and application by end-users. In practice, the combination of ADK products and services facilitates interfacing of existing assays with i-Diagnostics platform and stimulates the development of new i-Diagnostics applications. uTIRF station is shown at the Figure above with prism-TIRF accessory installed. The scheme of lightguide TIRF (lgTIRF) accessory is shown to the left from uTIRF. these accessories can be taken form uTIRF and installed at a microscope in no time. Cartridge blanks, manual microarrayer, and the i-Diagnostics reader with cartridge blanks are supplied with the Application Development Kit. These products have already been successfully used by several our collaborators.

​     ​i-Diagnostics Application Development Kit (ADK) is designed to facilitate all stages of assay development – from biomarker discovery to creating and testing the panels of assays. TIRF slide is the central part of i-Diagnostics cartridges. The slide carries on its surface microarrays that simultaneously detect protein, nucleic acid, and metabolite biomarkers. In most of the existing applications, protein, nucleic acid, and metabolite assays are enclosed into one common flow chamber. In specialized applications, protein, nucleic acid, and metabolite microarrays can be separated by partitions  – enclosed into three parallel flow chambers.  ADK is supplied with a manual microarrayer, which enables printing of the microarrays using micropipettes. Initial stages of bioassay development requires rapid access to individual spots of the bioassays. To facilitate the access, ADK contains open perfusion chambers as opposed to closed flow cells that are necessary to measure fast kinetics of response. 

    TIRF Labs has already received numerous requests from research groups worldwide to supply uTIRF and ADK products. We plan to start supplying these products along with experimental protocols. Several groups have already joined our project. We have incorporated their feedback and will incorporate future comments from our future customers in the next releases of the uTIRF and ADKs.  We will supply advanced hardware, software, reagents, development tools, protocols, videos, and other  support to accommodate the requirements for different diagnostic applications.

     The arrays of bioassays printed at the surface of i-Diagnostics slides contain internal controls to ensure reliability and quantitative calibration. The cartridge is equipped with a 20-microliter flow cell, which encompasses the microarray. i-Diagnostics requires no or minimum sample preparation. Whole blood can be analyzed after the addition of an anticoagulant. A simple sample preparation module is included in the cartridge;  space is reserved for more complex sample preparation modules as will be required for applications developed in the future. For more information contact us via email: info@TIRF Labs.com.

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​​​​​​​i-Diagnostics Applications

     Traditional molecular diagnostic devices detect biological markers either in the genome, transcriptome, proteome, or metabolome. While DNA  and RNA determine how the cells express their genes and produce proteins, proteins essentially rule  the cells and tissues, producing metabolites – the products of biological processes. In the individual, the complex of these molecules provides critical information to health: it can identify the disease (diagnose) and project the dynamics of future changes (prognose). To obtain the complete picture needed for diagnosis and to make a prognosis, one needs to detect all four classes of biomarkers. This aggregate of data improves the ability to better diagnose, monitor, or predict disease, detect risk, and decide which therapies will work best for the individual patient. Everyone is truly unique; we respond differently to the same drugs and to the same nutrients. By analyzing the specifics of the patient and their response, molecular diagnostics offers the prospect of personalized medicine.

     While typical methods of molecular diagnostics detect only one class of biomarkers, as mentioned above, i-Diagnostics combines detection over four classes of biomarkers: DNA, RNA, proteins, and metabolites. This unique feature makes i-Diagnostics open to the broadest range of applications. i-Diagnostics tests will be useful in a range of medical applications, including infectious disease, oncology, human leucocyte antigen typing (which investigates and predicts immune function), coagulation, and pharmacogenomics-the genetic prediction of which drugs will work best.

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      Applications for i-Diagnostics will include tests for:

• Prevention pandemics and epidemics

• Detection and diagnosing of infection diseases (COVID-19, influenza, Ebola, HIV, Zika, STDs, etc)

• Diagnosis and prognosis of cancer

• Diagnosis and prognosis of cardiovascular diseases

• Diagnosis and prognosis of Alzheimer’s, Parkinson’s and other neurological disorders

• Drug development studies   

• Longevity studies and popular efforts

• Food and water safety applications

• Civil and military biodefense applications

• Forensic applications

• Environmental applications

• Agricultural analyses and studies

     We believe that many routine analyses of blood, urine and other bodily fluids that currently are performed in clinical labs, will migrate to i-Diagnostics, because of the convenience and privacy of home use tests. Along with the main goal of home use, family doctors, cardiologists, dentists, first responders, pharmaceutical companies, food safety, agriculture, and environment protection specialists have expressed their interest in using i-Diagnostics for their applications. There are thousands of new applications that can be developed for the i-Diagnostics platform. It is too difficult, if not impossible, for a single company to develop all of these numerous applications. Therefore, we invite other research groups worldwide to join our team to interface their existing tests and develop new applications with the i-Diagnostics platform using the open source status and Open Innovation Business Model.

     To facilitate these efforts, we are offering the uTIRF turnkey station and i-Diagnostics Application Development Kit (ADK). We anticipate a large demand for uTIRF-ADK, because there are tens of thousands of research groups worldwide that develop diagnostic assays, discover and validate molecular markers, and investigate the molecular mechanisms of related biological processes. These research applications will pave the way for medical use of i-Diagnostics.

     In our laboratory based in North Carolina, TIRF Labs' team is developing diagnostic and prognostic tests for prostate cancer. We have developed i-Diagnostics tests for food safety and detecting allergens in food. Our long-term collaborator Dr. Vaca from the Institute of Cellular Physiology at UNAM and his group are developing preemptive diagnostic tests for Alzheimer’s disease and hepatitis C. His colleagues from other research groups will develop tests for pancreatic and colon cancer. Dr. Dong from Washington State University is developing tests for cardiovascular diseases. The Laboratory of Molecular Virology at the Food and Drug Administration have expressed their interest in using i-Diagnostics for the rapid detection of HIV and other infectious diseases.

     There are hundreds of other exciting applications that will be completely new for the healthcare area. In our laboratory, we are also working on longevity/rejuvenation tests. These studies promise rapid progress in lengthening the average life span, and preventing metabolic disbalances that result in premature aging. From personalized precision medicine, clinical and pre-clinical tests of new drugs,  and disease risks assessment to studies in food and water safety, detection of allergens, and other environmental and agricultural studies, i-Diagnostics offers the versatility for applications in all of these fields and more.

      After 9-11 and the anthrax letters attack, scientists warned the U.S. government about the necessity of massive coverage diagnostics and a knowledge-based biological safety infrastructure [1-14]. However, the concerns of scientists were frequently perceived as a doomsday panic. COVID-19 pandemic was a wake-up call.​The COVID19 pandemic highlighted the weakness of U.S. biodefense infrastructure. It is clear that our efforts have been more reactive than proactive. During COVID diagnostics was in high demand and unavailable to many. In 2020 we waited a day or two to know whether we are COVID positive or negative. As a result, thousands of people were infected before the results were available. The delays and the costs of testing are increasing mortality. It is up to all of us to be prepared for the future, lest we forget or ignore the next biological threat. Urge your U.S. senators to fund The Apollo for Biodefense Program.