Leveraging a contract from the U.S. Centers for Disease Control and Prevention, OpGen, Inc. (NASDAQ:OPGN) is on its way to commercializing its QuickFISH diagnostic products in Colombia initially, with plans for expansion throughout South America.
Shares of the Gaithersburg, Maryland-based company are up in Thursday trading following news of positive clinical trial results supporting the commercialization initiative.
OpGen said that it successfully completed a prospective clinical trial evaluating the impact of using rapid diagnostic testing to identify and treat bacteria and fungi in the blood of patients in hospital intensive care units in Colombia.
Last September, the CDC awarded OpGen a contract with the task of developing clinical support tools for infection control in low- and middle-income countries. The project funded development and evaluation of cloud-based mobile software.
The latest trial, hosted at four acute care hospitals in Colombia, resulted in a substantial improvement in survival and reduced antibiotic usage for patients that had their blood tested with OpGen's rapid diagnostic test.
Based upon the data and positive feedback from the hospitals, OpGen has gone ahead and established a subsidiary, appropriately named OpGen Colombia, for the purpose of commercializing OpGen's portfolio of precision medicine products in South America.
Stateside, the OpGen products are approved already by the U.S. Food and Drug Administration,
The plan is to first introduce OpGen's QuickFISH products, which is expected this quarter, followed by commercialization the company's Acuitas antibiotic resistance detection products that detect genes associated with CRE, Carbapenemase Producers, CTX-M related ESBLs, and VRE directly from one swab.
Shares of OPGN have swung wildly in Thursday morning trading with the news. After closing Wednesday at $2.09, shares gapped at the opening bell up to $2.35, dipped as low as $2.08 and shot up to as high as $2.79, the highest price for the stock since February 6.
Early into the afternoon session, shares are holding a gain of 16.6% at $2.44.
