Lateral flow assays (LFAs) are the behind low-cost, simple, rapid and portable detection devices popular in biomedicine, agriculture, environmental and food. 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.
