MicroGEM today announced it has been awarded up to $40.9 million by the National Institutes of Health (NIH), Rapid Acceleration of Diagnostics (RADxSM) initiative to expedite the launch of the company's molecular diagnostic test that provides rapid, sensitive and specific identification of SARS-CoV-2 and influenza types A and B at the point-of-need.
MicroGEM's COVID-19 saliva test provides laboratory-quality results in 15 minutes, allowing non-medical personnel to obtain rapid, on-site detection of COVID-19 without a laboratory. The system detects SARS-CoV-2 in saliva, simultaneously with influenza types A and B, using real-time reverse transcriptase RT-PCR. Based on patented enzymatic RNA extraction technology, the system is a simple approach to quickly detecting and managing infectious disease.
"We are pleased to be working with the NIH to accelerate the launch of this new platform to detect COVID-19," said MicroGEM CEO, Jeff Chapman. "This funding enables us to leverage the technologies currently in our pipeline, pivoting to address the urgency of this pandemic for a safe and expedient way to expand the availability of COVID-19 testing to those who need it."
The RADx initiative seeks to significantly increase the number, type, and availability of tests by millions per week. The technologies supported by the program are expected to make a significant contribution to expanding the nation's testing capacity. "Diagnostic testing is a critical component of the nation's strategy to meet the challenge of the COVID-19 pandemic," said NIH Director Francis S. Collins, M.D., Ph.D. "Just started at the end of April, the RADx initiative has moved swiftly to speed innovation and later-stage development in the biomedical technology sector. The results thus far have been outstanding."
This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADx SM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00015.
About MicroGEM
MicroGEM serves to democratize molecular biology by moving molecular techniques out of conventional, highly skilled laboratories to non-laboratory settings where they can be used at point-of-need to solve complex biological problems. The company's innovative enzymatic approach to nucleic acid extraction provides the foundation for rapid sample preparation suitable for PCR analysis. Coupled with MicroGEM's expertise in microfluidics and synthetic biology, the company is strongly positioned to create person-portable diagnostic devices, representing the next generation of rapid, point-of-need solutions to address global health concerns.