In addition to its pilot-scale manufacturing facility in Charlottesville, Virginia, molecular diagnostics company MicroGEM has established new large-scale production facilities in Hudson, New Hampshire and Ogden, Utah.
MicroGEM plans to create more than 500 jobs between both locations according to company officials. The facilities, with more than 120,000 square feet combined, give MicroGEM the capability of producing 160,000 tests per day.
MicroGEM reported it expanded with the acquisition of Jump Start Manufacturing, a New Hampshire-based engineering company with proven success in the biotech and pharmaceutical industry. The acquisition allows MicroGEM to rapidly scale production of its innovative Spitfire6830 SARS-CoV-2 testing system, a high-performance, PCR-based point-of-need saliva test.
"We are proud to join forces with the talented Jump Start team to accelerate the production and deployment of our innovative Spitfire6830 SARS-CoV-2 testing system," said MicroGEM CEO Jeff Chapman. "Bringing Jump Start's leading manufacturing capabilities and expertise under the MicroGEM umbrella and dramatically expanding our production capabilities will ensure that more Americans have greater access to high-quality COVID-19 tests, bringing key tools to help end this devastating pandemic."
MicroGEM's Spitfire6830 system is designed to detect SARS-CoV-2 in both symptomatic and asymptomatic individuals. The system is in the final stages of development with preparations underway for submission to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization. The project has been funded in part by the NIH Rapid Acceleration of Diagnostics 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.
"The unique capability of the Spitfire6830 to quickly provide highly sensitive and specific identification of SARS-CoV-2 from saliva samples puts MicroGEM at the cutting edge of point-of-need diagnostics," said Jump Start founder, Thomas Moran, who joins MicroGEM as COO overseeing all manufacturing activities. "Jump Start is thrilled to join the MicroGEM team, enabling us to help bring this low-cost, high-quality test to market while ensuring our Jump Start customers continue to receive the high-touch service they expect and deserve."
MicroGEM said it is democratizing molecular diagnostics by moving molecular techniques out of conventional, highly skilled laboratories to non-laboratory settings. The company's innovative enzymatic approach to nucleic acid extraction provides the foundation for rapid sample preparation suitable for PCR analysis.