Opgen (OPGN): 0.2399 + 3.58%
52w: 0.23 – 2.25
OpGen, Inc. is a precision medicine company that uses molecular diagnostics and informatics to combat infectious disease. The Company, through its subsidiaries, is focused on developing and commercializing molecular microbiology solutions helping to guide clinicians with actionable information infections caused by multidrug-resistant microorganisms (MDROs). The Company’s product portfolio includes the Curetis Unyvero System and multiplex syndromic panels, Acuitas AMR Gene Panel and Acuitas Lighthouse, and the ARES Technology Platform including ARESdb using next generation sequencing (NGS) technology and Artificial intelligence (AI) powered bioinformatics solutions for antibiotic response prediction, as well as the Curetis CE vitro diagnostic (IVD) marked polymerase chain reaction (PCR) based severe acute respiratory syndrome (SARS) CoV-2 test kit. The Company’s subsidiaries include Curetis GmbH and Ares Genetics GmbH.
ROCKVILLE, Md., Oct. 03, 2022 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or the “Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced that it has closed its previously announced registered direct offering with a single institutional investor for the purchase and sale of 9,660,000 shares of the Company’s common stock (or common stock equivalents), 33,810 shares of Series C mirroring preferred stock (“Series C Preferred”) and, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 9,660,000 shares of common stock, at a purchase price of $0.35 per share of common stock
ROCKVILLE, Md., Oct. 03, 2022 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced its successful completion of patient enrollment for its clinical trial for the Unyvero Urinary Tract Infection (UTI) Panel.
OpGen’s Unyvero UTI Panel tests for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers directly from native urine specimens. OpGen had recently added a fourth study site in the U.S. to optimize enrollment for different urine sample types to be included in the study, which enabled successful collection of over 1,800 urine samples.
“We’re excited to have completed sample enrollment with our four clinical trial site partners as planned. After having reached our goal of at least 1,500 prospective samples as recommended by applicable FDA guidance, our team will now conclude reference testing in preparation of unblinding and final data readout, and we will start working towards a subsequent FDA submission package,” said Johannes Bacher, Chief Operating Officer of OpGen and Managing Director of its German based subsidiary Curetis GmbH.
Given the complexity and comprehensive nature of the data sets, OpGen expects to conclude data analysis in the next couple of months. Unblinded data for each patient sample will comprise Unyvero UTI Panel results, standard of care microbiology from the clinical trial sites, as well as additional standardized central microbiology data from a reference laboratory.
