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BacterioScan Gets FDA Clearance for UTI Detection System

NEW YORK (360Dx) – In vitro diagnostics firm BacterioScan announced today that it has received 510(k) clearance from the US Food and Drug Administration for its 216Dx urinary tract infection detection system.

BacterioScan said it has signed a sales and distribution agreement for the system with Thermo Fisher Scientific unit Fisher Healthcare. Financial and other terms of the deal were not disclosed.

The 216Dx system uses a laser sensor to detect UTIs using urine samples in three hours, versus two days with traditional methods. In clinical testing, the system demonstrated 98.6 percent sensitivity with 99.6 percent negative predictive value, according to the company.

"Today's announcement is a significant milestone and the culmination of years of hard work by our team and clinical research partners," BacterioScan Chairman Greg Hewett said in a statement. "We ... look forward to continuing to develop our robust pipeline of additional applications, including antimicrobial susceptibility testing for UTIs, and infection detection and [antimicrobial susceptibility testing] for other bodily fluids."