iDiagnostics - the handheld future of precision medicine; Single Molecule Detection, Single Cell Analysis, Cell Membrane Studies, TIRF microscopy, TIRF accessories for fluorometers, TIRF biosensor instruments, Real-time TIRF microarrays, and more>>> visit www.tirf-labs.com
Handheld Molecular iDiagnostics
by TIRF Labs
Figure 1: iDiagnostics cradle with cell phone and cartridges for home use molecular diagnostic tests.
Turn your smartphone into an accurate, rapid, yet inexpensive diagnostic device for precision personalized medicine
Pursuing the objective of distributing uTIRF and iDiagnostics development tools, we will keep in mind that the ultimate goal of decentralized precision diagnostics is to make it available and affordable for all. An early prototype of iDiagnostics and disposable cartridges is shown in Figure 1. It is designed for home use by minimally trained individuals, similar to pregnancy test strip. However, iDiagnostics also can be used by medical doctors, first responders, clinical researchers, and other specialists. We anticipate that several months after we receive necessary funds, a number of tests for laboratory use - including food safety, allergens in food, prostate cancer, and breast cancer - will be developed, validated, and used for research purposes in academic, government, and industrial research groups.
The Goal of iDiagnostics Project
Our goal, which is also described above, is to make iDiagnostics available and affordable for every family on the globe. We believe that in several years, in the medicine cabinets of most families, there will be an iDiagnostics device, similar to that shown in Fig. 1, and a dozen of different cartridges dedicated to different diagnostic tasks, from food and water safety to predicting cardio-vascular problems. The handheld device and cartridges will be affordable to every family on the globe. While this ambitious goal is several years away (Fig.1 shows its early prototype), during Phase 1 of the project we plan to disseminate the uTIRF detection station and the iDiagnostics Application Development Kit (ADK) among member of biodetection community - research groups that are actively working in the areas of molecular diagnostics, biomarkers discovery, disease prevention and prognosing, food and water safety, bioterrorism prevention, environment protection, drug discovery and leads optimization, numerous agricultural applications, an so on. There are estimated 35 thousand research groups worldwide that are potentially interested in uTIRF and ADK. Several of them have already contacted us, before we completed the uTIRF. It appears that the gigantic task of changing the paradigm to individualized precision medicine is too difficult for a single firm, even a big one. Therefore, we envision distribution of the uTIRF and iDiagnostics ADK among the biodetection/diagnostics community so that thousands of research groups worldwide will be equipped with advanced tools for the discovery of biomarker and the development of precision diagnostics tests using panels of biomarkers.
Dr. Luis Vaca
Dr. Alexander Asanov
What Will You Change?
Your support of the iDiagnostics project will change the way how medicine works. Currently, medicine assumes that we all are the same, while everyone of us is truly unique. We respond differently to everything, including therapies. Blood transfusion is a rear exception in modern medicine, where patients are divided into several groups in accordance with their individual responses. In the future, the personalized approach based on precision diagnosing and individually tuned treatment will become common. Affordable accurate diagnosing is an essential part of this future. With iDiagnostics, you and your doctor will know precisely what is going on in your body, how your condition develops with time, and how your body responds to therapy or changes in your lifestyle. Today, there are three problems in diagnostics: (i) under-diagnosis - due to poor sensitivity of traditional tests diseases often remain undetected; (ii) over-diagnosis - due to the high rate of false positive responses the presence of a disease is erroneously reported, while, in fact, there is no threat; and (iii) no diagnosis - due to high cost and discomfort many of us prefer to avoid diagnosing. Being a sensitive, accurate, inexpensive, non-invasive or minimally invasive technology, iDiagnostics will solve all three problems. Early detection, predictive or preventive tests for cancer, Alzheimer's, cardio-vascular and infectious diseases, food safety, and other areas will benefit tremendously from the use of iDiagnostics. Your support will help to rectify the problem of imprecise or no-diagnosing, and thus will facilitate to fight numerous diseases efficiently.
Accurate and rapid diagnosis is essential for absolutely all healthcare actions. Detection of diseases, fighting cancer, heart and neurological diseases, prevention of epidemics, including Ebola, Zika, HIV/AIDS, avian flu, and SARS, testing new drugs, and many other areas critically depend on accurate and rapid diagnosis. Your support will significantly accelerate progress in these areas.
Today, our doctors and insurance companies possess information about our health. We seldom keep the results of laboratory tests in our files, despite their importance to us in being better diagnosed in the future. For our children, who carry similar genes, the results of our diagnoses have valuable information for their health. iDiagnostics will seamlessly enable your ownership of information about your health. You will own the data and decide whether to send them to your doctor or save them in your files. The technological opportunities for these changes have been embedded into iDiagnostics devices. Your support will help you to become the owner of information about your health.
The iDiagnostics ADK and uTIRF detection cube are shown in Figure 2. The set is intended for researchers who are interested in interfacing their existing tests and developing new applications for iDiagnostics. Several research groups worldwide have requested the uTIRF and iDiagnostics ADK. Several our collaborators from the academic sector and industrial groups will receive uTIRF and ADK set at a special promotional price. We offer the opportunity to sponsor a university student project, which will use the uTIRF and ADK for the development of molecular diagnostics tests. If you do not have a student in mind, but are willing to sponsor one for diagnosing a specific disease, we will be delighted to assist you in allocating a bright student and a valuable goal.
Idea of Handheld Diagnostics
Our cellphones are powerful computers equipped with low light super sensitive cameras. The idea behind iDiagnostics is to use them or their cameras and computers with a handheld cradle, which implements a supersensitive bio-detection fluorescence technology, called TIRF microarrays. Alternatively, on later stages the TIRF cradle will incorporate a dedicated low light camera and microcomputer rather than use a cellphone. This change will add little to the cost, but will allow to avoid legal and administrative issues with cellphone manufacturers, who are reluctant to permit modifications to their software for camera control and data acquisition. The use of iDiagnostics is as simple as blood glucose tests available today for diabetic patients. You start the iDiagnostics app on your phone and follow simple instructions. The app will instruct you to put your cellphone into the cradle, insert a cartridge, and apply a droplet of saliva, urine, sweat, blood, or other bodily fluids. The fluid will flow inside the cartridge over the TIRF microarray; which will detect the presence or absence of numerous molecular markers. Massive amounts of information will be obtained by taking pictures of the response of the TIRF microarray. The iDiagnostics app will analyze the images, and, in a matter of a few minutes, will provide recommendations on what to do.
How Does iDiagnostics Work?
iDiagnostics is a technology which detects multiple molecular markers of different classes in a droplet of saliva, urine, sweat, blood, or other bodily fluid. It is designed to be minimally invasive and maximally precise. Molecular markers are precise signatures or “fingerprints” of diseases. They appear in biological fluids several months before a cancer tumor develops, and at least several weeks before a heart attack strikes, giving us enough time to prevent the disease.
iDiagnostics employs a super sensitive technology, called 3D-enhanced TIRF microarrays, to detect molecular markers. Theoretically, thousands of bioassays can be included into a TIRF microarray. However, in most practical cases we do not need more than 20 markers to perform a test with a negligibly small rate of errors. TIRF microarrays are capable of detecting markers of four major classes: proteins, metabolites, DNA and RNA. Traditional tests are based on a single class of markers and are often too imprecise.
Figure 3 shows a photo and the schematics of iDiagnostics. The cradle and cartridge integrate optics, microfluidics, an electrochemical system, electronics, and nanoengineered bioassays into one handheld device, which implements TIRF microarray technology.
iDiagnostics is based on the phenomenon of Total Internal Reflection Fluorescence (TIRF) (Figure 4), which occurs at the interface between a plastic or glass slide and biological fluid. If the fluorescence excitation light enters the slide at angles of 63 degrees or larger, the light will bounce from the top and the bottom of the slide and excite fluorescence of multiple bioassay spots that are arrayed at the bottom surface of the slide, where the bodily fluid contacts the array.
Because TIRF is a surface-selective technique, which probes only a sub-micron layer of the fluid, bioassays that are immobilized at the surface are excited and fluoresce, while molecules and other particles in the bulk of solution are not excited, and respectively, do not fluoresce. This allows for the testing of complex biological fluids, such as whole blood, with no or minimal sample preparation, which drastically reduces the turn-around time between the moments "sample-in" and "result-out."
A classical TIRF array, which is shown at the bottom of Figure 4, can use only a sub-micron layer of bioassays, which is virtually a 2-dimensional geometry - bioassay molecules are immobilized in a single monolayer. Therefore, the fluorescence signal is low; expensive scientific-grade cameras are necessary to image them. In 2013, after experimenting with a multitude of materials, we discovered that silk fibroin, the same natural protein that spiders use for their webs, tremendously enhances the signal of TIRF arrays. Silk fibroin is one of the few natural proteins whose refractive index is close to that of glass. This property is responsible for the beautiful shimmering of silk fibers in clothing. If deposited onto a glass or plastic slide, silk fibroin captures the excitation light, becomes an integral part of TIRF lightguide, and allows for an increase in the amount of immobilized bioassay molecules by a thousand-fold. Silk-enhanced TIRF arrays fluoresce brightly; and cell phone cameras are sensitive enough to detect their response. Additionally, silk is a remarkably stable protein. Its shelf life extends to several months and even years. Silk also stabilizes other biological molecules that otherwise would require refrigeration, a quality very desirable for applications in low resource settings. Recently, we developed new materials that are more robust than silk and function similar to silk. We updated the name from silk- to “3D-enhanced” TIRF arrays.
For the detection of DNA and RNA markers, iDiagnostics uses bioassays, termed molecular beacons. In the absence of target DNA or RNA, the fluorescence of a molecular beacon is quenched. The left panel of Figure 5 illustrates that upon binding to target DNA or RNA the molecular beacon opens and its fluorescence is dequenched. Irrelevant, non-target DNA or RNA do not open the molecular beacon; its fluorescence remains quenched. For the detection of protein and metabolite markers, iDiagnostics employs immunoassays based on antibodies, as shown in right panel of Figure 5. For more information about the principles of 3D-enhanced and classical TIRF microarrays please visit www.tirf-labs.com
Figure 4. 3D-enhanced TIRF microarray in comparison with classical 2D microarray.
Figure 3. Photo and schematics of iDiagnostics.
Figure 5. Molecular beacon assay for detection of DNA and RNA markers and immunoassay for detection of protein markers.
TIRF Labs Team
The following scientists and engineers have contributed significantly to the development of TIRF microarray and iDiagnostics technologies: Luis Vaca, Ph.D.; Vladimir Omelyanenko, Ph.D.; Angelica Zepeda, Ph.D.; Alicia Sampieri, Ph.D.; Philip Oldham, Ph.D.; W. William Wilson, Ph.D.; Theodore Winger, Ph.D.; David Sachs, M.S.; Hardie Johnson, B.A.; David Landis, Ph.D.; Ryan Sherry, M.S.; Tyson Weiss, B.A.; Zhanna Brotsman, M.S., Grant Leonhard, Timothy Pike, and Alexander Asanov, Ph.D.
Personal Statement of Lead Scientist
I, Dr. Alexander Asanov, believe that I am well-suited to lead the iDiagnostics project. This project logically builds upon my prior work. In 1999-2014, I served as Principal Investigator on several BAA and SBIR grants, awarded by NIH and HSARPA. I assembled and led a team of scientists and engineers, who have developed a family of innovative TIRF instruments for molecular diagnostics and analysis of biomolecular interactions. My colleagues and I have pioneered several ground breaking discoveries and accumulated unique experience in using TIRF technique and other analytical methods for life science applications. I have a broad background in spectroscopy, electrochemistry, surface chemistry, molecular biology, cell biology, nanoengineering, mechanical engineering, and optical engineering, which are key areas for this project. Each of our prior projects resulted in the development of useful TIRF devices and instruments. Our customers from academic and pharmaceutical research groups have generated unique research data using our products, and have published articles in leading scientific journals. I have a record of successful R&D projects in the area of molecular diagnostics and believe that my prior experiences have prepared me well to lead the proposed project. I am a naturalized U.S. citizen. In 1994, I immigrated from Russia. On my 24th year in the U.S, I feel that I am more American than Russian. My second Motherland recognized my accomplishments and rewarded me more than I could have dreamt of in Russia. I want to give back to the society and believe that the development of iDiagnostics is the way, in which I can demonstrate my gratitude to America and the world.
Neither human subjects nor laboratory animals are involved in this project. Genetically modified organisms and biologically hazardous materials are not involved either. Our collaborators, who do perform regulated studies, carefully comply with the respective government protocols and rules.
The field of lifesciences, in general, and the area of molecular biology, in particular, operate with powerful technologies that have strong potential for improving quality of our life. However, these powerful tools, if used improperly, can cause adverse effects. We believe that scientists should be responsible for results of their studies. It is our company policy and responsibility of our workers to foresee possible adverse effects of our studies and adhere to the highest ethical standards to avoid possible adverse effects. We do not develop and do not support the development of controversial biological applications.
Compliance with FDA Guidance
TIRF Labs complies with the U.S. Food and Drug Administration guidance, including the following:
The Software guidance documents http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089543.htm
Design Considerations for Devices Intended for Home Use
Guidance for Molecular Diagnostic Instruments with Combined Diagnostic and Research Functions
We are grateful to the National Institutes of Health, Mr. Michael Astrachan - XVIVO Scientific Animation, Genome British Columbia, The Howard Hughes Medical Institute, and Dr. David Goodsell, The Scripps Research Institute, for their kind permissions to use their videos and images.
Risks and challenges
TIRF Labs has been working on molecular diagnostics for the last forteen years and has created a family of TIRF instruments, including bench-top, portable, and handheld TIRF biosensors. We have assembled a group of scientists and engineers with vast experience in all relevant fields. However, a project of such scale as iDiagnostics involves new risks. To mitigate the risks of transition to clinical analyses , we are offering to the biodetection community uTIRF biodetection station and iDiagnostics Application Development Kit (ADK). uTIRF-ADK will involve a number of diagnostics research groups with their own networks, which will facilitate entering of iDiagnostics into conservative area of clinical analyses. The research and development for uTIRF and iDiagnostics have worked, the prototyping and low-volume manufacturing of these products has been done. Now, a group of risks will be associated with the transition from low-volume manufacturing to volume production. To mitigate these risks, we are establishing parallel contacts with alternative manufacturing partners and collaborators to assure multiple possible channels for production. If a setback does arise in one of the channels, we will use an alternative channel. iDiagnostics is a sophisticated technology. We are using a number of unique methods and production technologies. We believe that we are able to foresee and minimize risks associated with these methods in order to deliver uTIRF and iDiagnostics ADK to our customers with full satisfaction. Keeping our existing and prospective customers updated about our progress and receiving feedback from them is our priority.
How iDiagnostics Was Born
iDiagnostics is the result of a 11-year effort by our group of scientists and engineers. We have received $4.3 million in grants from the U.S. government and have developed a super-sensitive technology - 3D-enhanced TIRF microarrays. As mentioned above, TIRF is an exceptionally sensitive method capable of detecting biological particles down to single molecules. In iDiagnostics, TIRF allows for the super-sensitive detection of proteins, DNA, RNA, metabolites, and selected chemical agents. The sensitivity and dynamic range of iDiagnostics is sufficient for detecting virtually all clinically significant proteins, RNA, DNA, and metabolite markers. Figure 6 shows our progress in the development of TIRF array biosensors, which spanned from large bench-top instruments created in 2005, through portable sensors produced in 2009, to small handheld devices built in 2011. In 2013, we discovered that silk fibroin enhances the fluorescence of TIRF microarrays so that we can use a cellphone camera instead of expensive cameras. This patent-pending discovery has been incorporated into iDiagnostics. In Phase 1 of the project iDiagnostics will migrate back to the handheld configuration, in which the cradle will be equipped with its own low light camera and microcomputer. This turn will add little to the cost of the cradle, and will allow for avoiding several issues related to the use of cellphone software and to alignment of different cellphones with the cartridge.
Figure 6. Downsizing TIRF microarray biosensors.
Future applications for iDiagnostics will include diagnosis and prognosis of cancer, cardio-vascular diseases, Alzheimer's disease and other neurological disorders, longevity studies, diagnosing of influenza, Ebola, HIV/AIDS, Zika, STD, and other infectious diseases, food and water safety, biodefense, forensic, environmental, military, and agricultural analyses. We believe that many routine analyses of blood, urine and other bodily fluids that at the present time are performed in clinical labs, will migrate to iDiagnostics, because of the convenience 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 iDiagnostics for their applications. There are thousands of new applications that can be developed for the iDiagnostics platform. For a single company it is too difficult, if not impossible, to develop all these numerous applications. Therefore, we invite other research groups worldwide to join our virtual team to interface their existing and new tests with iDiagnostics platform. To facilitate these efforts, we are offering the uTIRF biodetection station and iDiagnostics Application Development Kit (ADK) shown in Figure 2. This set of uTIRF and ADK contains all necessary components for the development of diagnostic applications; it includes the hardware, software, development tools, cartridge blanks, reagents, experimental protocols, and the description of methods necessary for development. We envision that the uTIRF-ADK will be our main product during Phase 1. We envision that there will be large demand for uTIRF-ADK, because there are tens of thousands research groups worldwide that develop diagnostic panels, discover and validate molecular markers and investigate molecular mechanisms of related biological processes. These research applications do not need FDA approvals, but they will pave the road to medical use of iDiagnostics.
In our laboratory in North Carolina we are developing diagnostic and prognostic tests for prostate cancer. We have developed iDiagnostics 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 tests for early diagnosing of 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 heart diseases. The Laboratory of Molecular Virology at the Food and Drug Administration expressed their interest in using iDiagnostics for rapid detection of HIV and other infectious diseases.
There are hundreds of other exciting applications that will be totally new for the healthcare area. In our laboratory in North Carolina we are working on longevity tests. These studies are promising rapid progress in the increase of length of life and preventing metabolic disbalances that result in premature aging. Personalized precision medicine of the future, clinical and pre-clinical tests of new drugs, disease risks assessment, food and water safety, detection of allergens, environmental and agricultural applications will benefit tremendously with iDiagnostics.
How iDiagnostics Compares with Alternative Technologies
We have carefully examined the multitude of alternative methods and found that iDiagnostics is a superior technology for precision medicine, including home use diagnostics. To the best of our knowledge, iDiagnostics is the only technology which is accurate and rapid, multiplexed along four major classes of molecular markers, yet can be downsized to an inexpensive handheld device. The projected cost of iDiagnostics cradle is $200, and disposable cartridges are anticipated to cost $1-3. We are not aware about other technologies that could be as sensitive, accurate, rapid, detect all four major classes of markers, and yet be affordable. The closest competing technology appear to be biodetection based on electrochemiluminescence (ECL) assays. ECL assays, however, require labor intense sample preparation. Additionally, ECL detection requires both electrochemical and luminescence subsystems, which results in larger costs of the system.
After 9-11 followed by the anthrax letters attack, the U.S. government invested over $80 billion in bio-defense. There is no analytical technique that has not been tried for bio-detection. However, most of the techniques are too imprecise or too costly. The Department of Defense is carefully monitoring existing and emerging technologies that can be used for protection of the U.S. soldiers against biological warfare agents. In 2013 DOD issued a 663-page document , which ranked our classical TIRF array biosensors among most promising devices that are well-suited for military applications. We performed further analysis from the standpoint of civil applications and compared iDiagnostics with alternative technologies that theoretically could be employed for home use. We found that iDiagnostics showed several superior advantages, including (i) the low limit of detection and high sensitivity sufficient for detection of virtually all clinically significant markers, (ii) the broad dynamic range, which covers the entire spectrum of bio-marker concentrations that are clinically significant for the diagnosing of diseases, (iii) the capability of simultaneously detecting three or more classes of biomarkers: proteins, nucleic acids, and metabolites, (iv) exceptional flexibility of the platform which allow for interfacing bioassays as well as chemical assays for detection of bioanalytes and chemical analytes of different classes. To the best of our knowledge, iDiagnostics is the only technology which is capable of providing such combination of advantages for precision and rapid molecular diagnosing, yet at an affordable cost.
Why We Are Asking for Your Support
TIRF Labs’ iDiagnostics project does Not pursue a commercial goal. Our goal is to make accurate diagnosis affordable to every family on the globe. Rather than involving a venture capital or selling iDiagnostics to a big-name company, we are seeking The Giving Pledge donations, US government and international grants, sponsorships, and donations from individuals and organizations, so that we can guarantee affordable access to this life-saving technology - precision medicine for every family on the globe. We are not interested to create just one more expensive diagnostic technology for centralized laboratories.
It appears that the acquisition of the iDiagnostics technology by a large firm would produce one more costly diagnostic system, which the majority of population would not be able to afford. Indeed, the goal of large firms is to generate maximum income for their shareholders. It would be against their rules to sell iDiagnostics at a price that is significantly lower than the current market price for similar systems.
The involvement of venture or angel capital firms appears to be even less efficient than the possible acquisition of the iDiagnostics by a large firm. Unfortunately, the rate of success for typical venture/angel capital firm is less than 5%, meaning that just one company, which is successful, should cover losses incurred by 19 unsuccessful startups that did not make it to the market.
We believe that iDiagnostics project is an innovation, which will have enormous social impact, save millions of lives, and revolutionally improve the healthcare for everyone on the globe. We hope that the members of The Giving Pledge, the US government, individual and institutional sponsors, and eventually the general public will support the iDiagnostics project. It will be more than just an exciting new technology. This project will also create a new community, which will work together to revolutionary improve the quality of healthcare.
Open Innovation Approach
In order to make accurate diagnostics available to everyone, we are using the “open innovation” business model, which involves collaborative efforts with other research groups. We have successfully collaborated with several groups worldwide and plan extended collaboration to better meet a broad spectrum of needs of our customers. Several of our products, including iDiagnostics, have been inspired by our customers and collaborators. iDiagnostics has been developed in collaboration with one of our long-term partners - the research group of Dr. Vaca from UNAM. We plan to further extend the approach of “open innovation”, because we believe that knowledge in the field of life sciences is broadly distributed. Innovations and efficient transfer of them to the market place assumes close collaboration with external research groups. To stimulate the flow of innovations in and out of our company, we will offer to license the intellectual property of our collaborators and will offer them the opportunity to license our technologies.
About the iDiagnostics project
TIRF Labs introduces a supersensitive, accurate, rapid, yet affordable diagnostic technology, which we named “iDiagnostics.” It uses the photo camera and computing capabilities of a cellphone to measure and analyze the response of a microarray of bioassays printed on the surface of TIRF sensor chip. TIRF stands for Total Internal Reflection Fluorescence. TIRF is our core technology. TIRF is a uniquely advantageous technique, sensitive down to a single molecule and capable of detecting multiple biomarkers - from a few to several thousands - simultaneously. Panels of several biomarkers provide accurate molecular “fingerprints” of diseases. iDiagnostics detects biomarkers of four different classes: proteins, metabolites, DNA, and RNA. The detection of different classes is necessary for accurate diagnosing. In the near future iDiagnostics will migrate from using a cellphone to a dedicated handheld cradle, equipped with camera and microcomputer to avoid legal issues of using deep layers of cellphone software for iDiagnostics applications.
iDiagnostics will become an indispensable tool for the precision medicine of the future. Despite its small sizes and low cost, iDiagnostics will be as accurate and precise as a large centralized clinical laboratory. We are closely familiar with competing analytical technologies applicable for molecular diagnostics. Partially, these technologies have been surveyed in the DOD review along with three our products . Our TIRF array technology and devices were ranked high in the survey . From the standpoint of technical performance, the closest competitor of iDiagnostics is Electro-Chemi-Luminescence (ECL). However, for precision medicine of the future, for which the factors of low cost and decentralized home use are of paramount importance, ECL is far behind iDiagnostics.
iDiagnostics project seeks government grants, sponsorships and donations from individuals and organizations. We extend our quest for funds to the “The Giving Pledge” also known as the “Billionaire Giveaway Club.” We believe that iDiagnostics represents a unique opportunity for the Giving Pledge members to return to the society and to secure better future for the entire mankind. There is a consensus among experts that naturally occurring pandemics, as well as man-made synthetic pathogens, represent the deadliest risks to the existence of mankind. The envisioned iDiagnostics will allow for minimizing these risks. This technology will be at the forefront of prevention and the first response, which is the most efficient, in the middle, as well as at the end of combating the pandemics.
At the present time, TIRF labs is reluctant to involve a venture capital, partnership with large firms, or other for-profit route. It appears that these routes would result in one more expensive diagnostic technology, while the precision medicine of the future requires an affordable diagnostics available to everyone. Therefore, TIRF Labs is continuing the develop iDiagnostics using its own small income generated by sales of our existing TIRF products. To accelerate the development of this much needed technology, we are seeking for the Giving Pledge donations, US government grants, and sponsorships and donations from individuals.
iDiagnostics will help to rectify one of the most fundamental problems of modern medicine - inaccurate diagnoses. According to recent study from Johns Hopkins University, documented medical errors represent the third leading cause of death in the USA [2. Makary M.A., Daniel M., BMJ 2016; 353: i2139]. Medical errors are reluctantly reported. If corrected for un-reported errors, this cause might come ahead of cardiovascular and cancer. Inaccurate diagnoses are at the forefront of medical errors. False positive, false negative diagnoses, and “no-diagnosis” due to discomfort of costly and invasive procedures, account for the large number of medical errors. iDiagnostics will rectify these problems.
This project will make accurate, rapid, and minimally invasive diagnosing available to everyone. We envision two phases of the project. During Phase 1, TIRF Labs will distribute the the uTIRF detection station and iDiagnostics Application Development Kit (ADK) to research groups of the diagnostics community. uTIRF - ultimate TIRF biodetection station - is designed for the development of individual bioassays and combining them into panels containing up to 1000 assays. It is too difficult to develop assays and validate panels of assays using handheld iDiagnostics devices, because they use closed cartridges. The uTIRF station is equipped with open perfusion chambers that facilitate the development stage. uTIRF is an exceptionally flexible TIRF system; it will equip research groups with advanced tools that will help in elucidating the molecular mechanisms, facilitate the discovery of biomarkers, assist in the development of bioassays, help in assembling accurate panels of them, and the interfacing of new and existing bioassays with the iDiagnostics platform.
We have already received numerous requests for the uTIRF and ADK from research groups worldwide. Collaborating with other groups, we will pursue the business model of “open innovation,” which assumes a two-way exchange of ideas and innovations between other research groups and TIRF Labs. Phase 1 will create a broad base of groups that are practically using supersensitive, accurate, and rapid diagnostic technology in their labs and approved clinical studies. In Phase 2, TIRF Labs will perform the transition from prototypes to the large scale manufacturing of iDiagnostics devices. We envision a cradle, which will incorporate all necessary functions of the cellphone, which will make the project and the device more flexible and independent from legal issues with cellphone manufacturers. We also envision that routine blood and urine tests, food and water safety, environmental analyses ad many other tests will be modified and interfaced with the iDiagnostics platform. It will allow to transfer the entire spectrum of analyses from current laboratory-centered approach to person-centered diagnostics.
The challenge of creating a revolutionary new, accurate, rapid, and personalized diagnostics can not be adequately addressed by a single firm. Therefore, we carefully plan to involve multiple research groups into this project, the entire diagnostic community worldwide. Together, we will build the foundation for precision personalized medicine of the future. The unique set of iDiagnostics’ advantages, which is not found in competing technologies, provides the basis of our confidence that iDiagnostics is far ahead of alternative methods. We invite you to become a part of this exciting process of creating the precision medicine of the future. There is no alternative to iDiagnostics in decentralized, personalized precision medicine. Please consider donating or sponsoring the iDiagnostics project. iDiagnostics will allow you to perform precision diagnoses, predictive and preventive tests in the comfort of your home. >> More>>
iDiagnostics - the Hadheld Future of Precision Medicine
accurate, rapid, personalized, yet affordable molecular diagnostics
1. 2013 Global CBRN Detector Market Survey, 250 MB pdf file downloaded on May 1, 2015 from URL:
http://www.cbrnlibrary.com/documents/Global%20CBRN%20Detector%20Market%20Survey_web.pdf , If the link does not work, email your request to TIRF Labs; we will dropbox the pdf file for you.
2. Makary M.A., Daniel M., Medical error - the third leading cause of death in the US; BMJ 2016; 353: i2139.
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