OpGen rises on seeking special clearance pathway for UTI device

CapForce

18/04/2023 13:52

** Shares of diagnostics firm OpGen Inc  OPGN.O  rise 7% to
$1.29 premarket
    ** Company requests U.S. FDA for "De Novo" clearance pathway
for its investigational testing device to diagnose urinary tract
infection
    ** The De Novo pathway is used by the FDA for novel medical
devices that do not have any other similar devices to compare to
    ** OPGN's UTI device showed 96.8% sensitivity and 97.4%
specificity in a 1,800-patient study evaluating its quantitative
detection potential for microorganisms
    ** Stock down 57% YTD

 (Reporting by Aditya Samal)
 ((Aditya.Samal@thomsonreuters.com;))