Opgen nearly doubles as UTI panel study meets main goal

CapForce

13/12/2022 14:06

** Shares of diagnostics firm OpGen Inc  OPGN.O  surge ~94%
premarket to 24 cents, among top pct gainers across U.S.
exchanges trading before the bell
    ** Co says its Unyvero Urinary Tract Infection (UTI) panel
met main goal of study which was designed to detect urinary
tract infections
    ** Prelim analysis from the study shows overall weighted
average sensitivity of 96.4% and overall weighted average
specificity of 97.4% vs standard of care - OPGN
    ** The study has enrolled over 1,800 patient samples at 4
U.S. clinical trial sites - OPGN
    ** Co says results will be used to prepare submission
package for De Novo request to the U.S. FDA which provides a
marketing pathway to classify novel medical devices
    ** Up to Monday's close, stock had fallen ~87% YTD 
 (Reporting by Sriparna Roy)
 ((Sriparna.Roy@thomsonreuters.com;))