PhaseI_Innotechprecisionmedicine_CDC_NCEZID_031

Current diagnostic approaches are not sufficient to limit the expansion of infectious diseases at early stages. For preparedness to combat future pandemics, epidemics, endemics and biothreats, efforts and finances should be devoted to the development of high-performance, portable, point-of-care (POC), multiplex tests that can be performed at patient’s side and are field-deployable, rapidly, accurately and at low-cost. InnoTech Precision Medicine has developed and optimized the chemistry for highly accurate and rapid detection of viruses with a direct lysis to one-pot LAMP: CRISPR assay, called Recognize™, that is like the SHERLOCK assay. In our assay, we have removed the need for nucleic acid (NA) isolation. False positives that are major drawbacks of some of the current rapid PCR tests are also significantly removed. Our chemistry is optimized for a specimen to result turn-around time 30 minutes. We have also developed an initial prototype for a cartridge and an engineering breadboard device for all enclosed and easy-to-use tests. Our aims in this proposal are to 1) develop and optimize the recognize™ chemistry for mpox virus; 2) carry out a pilot study using live virus in BSL3 facility.