Abstract

New Tools to Help Developers of Point of Care Diagnostics

Joany Jackman, Senior Scientist, Research and Exploratory Development, The Johns Hopkins University Applied Physics Laboratory

As part of our mission with Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Disease, the Johns Hopkins University - Applied Physics Lab (JHU-APL) has developed several tools to assist companies developing point-of-care tests for STD and now COVID-19. One resource is the Technology Watch Database (TWD), a free on database containing diagnostic devices for sexually transmitted infections and for COVID-19 diagnostics.  In 2020, we created a new tool to assist developers by providing on line access to systems engineering support for their technology.  The Self-Assessment Systems Engineering (SASE) tool queries applicants in 24 different areas influencing technology development. While the tool contains as many as 450 questions, only a subset is displayed to each applicant as determined by the dynamic responses to the questions based on the current technology readiness levels (TRL). Generally this tool applies to TRL 3 through 7. Responses to the SASE (and supplemental materials )are submitted to JHU APL for review by subject matter experts in various technical areas as well as experts with experience in overall development of point–of-care assays.  A combined report is sent to the SASE applicant within approximately 30 business days with a follow up meeting with JHU APL to discuss the report.  Currently the SASE tool is free through the NIBIB POCTRN. Finally we will offer Tactical Funding to companies interested in developing test which target STDs.  Well developed tests for other targets capable pivoting to STD diagnostics will be a priority for funding.