Mesa Biotech Inc., a molecular diagnostic company that developed a polymerase chain reaction testing platform designed specifically for point-of-care, has completed a major expansion of its San Diego manufacturing facility, increasing the facility footprint by 68 percent and enabling the company to produce millions of flu tests annually.
Polymerase chain reaction now is a widely used molecular biology to make millions of copies of specific DNA segments.
Mesa Biotech manufactures the Accula Flu A/Flu B Test and the Accula RSV Test that have both obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) this year. Both products are distributed in the U.S. and Canada by Sekisui Diagnostics under the Silaris brand and via a number of strategic distribution agreements in Europe and Asia.
“The timing for completion of the facility is optimal,” Hong Cai, co-founder and chief executive officer, Mesa Biotech, Inc. “As we enter the coming flu season, our new facility will provide manufacturing capacity to support the diagnostic needs of physicians, enabling them to administer accurate and timely treatment to their patients.”
The expanded facility incorporates infrastructure and equipment to enhance productivity, collaboration, and innovation. The expansion also nearly doubles Mesa’s workforce, with the addition of engineering, product development, and manufacturing positions.