THE PURPOSE OF THIS MODIFICATION IS TO UPDATE THE DELIVERABLE DUE DATES FOR RADX TECH PROJECT 2200

Our DASH-HT molecular diagnostic system will detect SARS-CoV-2 RNA in asymptomatic subjects in 12 minutes with a throughput of 30 per hour.  Specimens can be nasal or nasopharyngeal swabs.  Less than 1 minute of operator time is required to elute specimens in the cartridge and scan barcodes.  The cartridge, which is closed after removing the swab, contains all reagents needed for extraction, purification and RT-qPCR.  40 cycles of qPCR are performed in less than 5 minutes after sample prep which takes 7 minutes. Six processing units are housed in a cabinet that contains power and environmental control system so the system can be run outdoors year round.  It is small and light enough to be transported as checked luggage on domestic airlines.   Cartridges are designed to be stable for at least 1 year at ambient temperatures of 4 to 30 degrees C.  They are creditcard sized for high density packaging. Our SARS-CoV-2 RT-qPCR assay has  analytical sensitivity of 10 copies, and has been multiplexed with a process control.  Alpha prototypes are currently running in CIGHT R&D labs.  They are recently-modified versions of a point of care system that has been in development for 3 years.  It was scheduled to go into clinical trails with flu A/B and STI panels at the end of this year.   While this high-throughput version will immediately fill a critical gap in COVID testing, systems can be scaled down to meet needs of urgent care clinics and doctors offices that may be involved in the future.