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BacterioScan, a BioGenerator portfolio company, secures FDA clearance – UTI detection in hours, not days

May 14, 2018

St. Louis, May 14, 2018 – BacterioScan, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a 510(k) Premarket Notification clearance for its 216Dx Urinary Tract Infection (UTI) detection system. The BacterioScan 216Dx system is a rapid automated diagnostic system for the detection of bacterial UTIs, one of the most common types of infection.

Current UTI testing is a labor-intensive, manual culturing process that typically requires two days or more to yield a result. The BacterioScan 216Dx system utilizes an advanced laser sensor to rapidly detect infections, reducing lab turnaround time to just three hours, an improvement of up to 90%.

“Our rapid UTI detection system can quickly guide the most effective therapeutic responses to cure infected patients,” said Dana Marshall, BacterioScan’s President and Chief Executive Officer. “Faster detection of infection means better patient outcomes and diminishes over-prescription of antibiotics. Inappropriate and excessive antibiotic use promotes drug resistance, a serious and growing global health crisis.”

 

See the Press Release Here