DDI envisions its novel platform technology to usher in the USA and globally a ‘best in class’ rapid diagnostic test LFA, FDA approved (unconditioned) for diverse medical utilities (viral, other infectious agents and medical diagnostic at large). Exquisite sensitivity, accuracy, reliable and super-rapid along with the logistic advantages of the OER will become the “gold Standard” for years to come. The “multi-color Centers” next generation platform will secure decades of leadership for cluster analytes reporters. Covid-19 RDT LFA is Debina Diagnostics second targeted for functional nanodiamond technology (after EBV) is a ‘trail blazer’ towards the ultimate goals. Our LFAs achieve exponentially greater improvements in test sensitivity, speed, throughput, and ancillary benefits. Our vision is that the test will be recognized as ‘best in class’, with the potential to ultimately replace colorimetric (visual) LFAs used by U.S. healthcare providers and global government and non-governmental organizations (NGOs). Furthermore, functional nanodiamond based OS is expected to have a long shelf life, thus may attract the interest of U.S. government agencies (HHS, DHS, DOD, USDA, and EPA) to acquire billions of tests as part of the National Stockpile, to ensure future national preparedness for unforeseen pandemics. Further commercial opportunities could include broad distribution of the OER to retail pharmacies to enable affordable self-testing at up to 10,000,000 tests/day (across continental USA). Interests by foreign governments and international health organizations (UNICEF, WHO) could follow. Debina’s longer term vision includes self-testing at non-medical facilities (airport terminals, international borders crossings and large public events). Debina’s successful introduction of the next generation duplex test and in longer term multiplex tests (based on multicolor nanodiamond) could facilitate testing efficiency, assist in differential diagnosis of cause of poorly differentiated clinical syndromes (e.g., Flu like upper respiratory infection) that can be caused by several different viral pathogens (flu, corona, rhinoviruses, parainfluenza, pertussis etc.), thereby guide treatment, define prognosis and isolation needs.
•Our instrument is an onto-electronic reader that operates on battery (chargeable via solar panel). It is a mobile (4x5x8”), easy to operate minimal training.
• Additional features could easily add such as transmission of data from point of test to centers of data processing, and epidemiological statistics. High throughout, mobility and reproducibility Of testing afforded by non-perishable FND-(NV) core.
• Debina Diagnostics INC., (DDI) is a developing early stage Bio company focused on development and commercialization of innovative imaging based of fluorescence energy used for diverse medical diagnostics and therapeutic conditions. This new imaging can be used in an ambulatory setting for both the civilian and military sectors. DDI also lends itself for diagnosis of broad environmental hazards and epidemiological surveys.
• DDI’s core is based on novel Fluorescent NanoDiamond particles engineered (physically) to emit strong Near Infra-Red (NIR) light upon exposure to specific Laser light (F-NDP). DDI affiliated laboratories specialize in Bio-Engineering of the F-NDP by additives linked to the particles that enable homing of the particles on targets of interest such as infectious pathogens (viruses, bacteria, toxins) and pathological loci in human body (such as blood clots, vascular plaques, tumors etc).
Repeated outbreaks of Ebola Virus endemic/epidemics outbreaks in the West Africa countries are still claiming large number of lives, devastate communities and carry threat to the international communities (pandemic expansions). Early detection of sources, carriers and sentinel patients has been a critical un-resolved problem. No credible, high sensitivity surveillance methods that routinely monitor areas of high risk are available for early alarm of new outbreaks. Debina Diagnostic in collaboration with USG/DoD (USAMRIID), Millipore (Bedford MA), and others have formed a consortium to develop advanced diagnostic/surveillance test of superior sensitivity, speed, quantitative/objective ‘read-out’ based on Near Infra-Red (NIR) emitted from Fluorescence NanoDiamonds-NV.
The inability to conduct routine, frequent surveys of the EBV incidence and prevalence in endemic countries at risk for periodic large epidemics outbreaks is the root of the failure for early detection and response. Intense and comprehensive surveillances including most rural/austere locals is simply not feasible due to lack of proper technology. The DRC (Democratic Republic of Congo) where EBV endemic condition persist, acknowledges that continuous surveys of environmental sources for incidence/prevalence of fever generation viruses is the most effective early measure to curtail emergence of endemic outbreaks. Early detection of Ebola Virus (EBV) is crucial to contains, prevent, treat, and abrogate threats of large-scale outbreaks such as the 2014-2015 outbreak in multi African countries. At the patient level, exceedingly early detection and initiation of diverse medical measures (isolation, palliative, treatment, and rehabilitation) are critical for survival. Contemporary tests (except for PCR) do not meet such sensitivity needs and PCR based tests are not practical solution for routine population surveillances in less developed (no electrical grids) environments surveys. DRC officials acknowledge the need for rapid dissemination and validation of data and ‘online’ distribution of information to local, regional and international organizations, the lack of such capabilities humpers early mobilization and swift containment efforts. The USAMRIID based CRADA aims to provide exactly such capability in line with Global Response System”. Such capabilities do not exist yet.
Solutions for the periodic outbreaks of EBV disease in West African Countries have been attempted since 1976, when Ebola viruses were first identified as the cause of a highly lethal, highly contagious Hemorrhagic Fevers Viral disease. Over 4 decades and much treasure spent, attempts to curtail the periodic spread of the virus, and eliminate the endemic and epidemic threats have made little progress. In fact, the largest epidemic outbreak in 2014-2015 has claimed tenths of thousands infected individuals resulting in estimated 50-60% mortality is a testimony to the magnitude of failure to introduce the necessary mitigating capabilities. Virtually, no specific treatment has been proven efficacious, vaccine is an ongoing saga of unclear consequences, surveillance system is not implemented and electronic early alert systems from “point of test to headquarter” not yet erected. We submit that the key action to make meaningful progress on this difficult problem MUST start with surveillance/diagnostic efforts across endemic zones for HFV risk. To this end, a revolutionary diagnostic test has been developed by a consortium of experts operating under USG/DoD (USAMRIID) CRADA. The technology in advanced development provide technology that will be easy, simple, and safely to operate in most remote, austere locals as well as urban developed clinics. The technology offers exquisitely superior sensitivity, speed of operation, quantitative (objective data) and most important- instant transmission of test results to centers associated with the “Strategic Response Plan” authorities of the Ministry of health and other interested parties.
