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April 25, 2015 9:27 PM ET

Biotechnology

Company Overview of OpGen, Inc.

Company Overview

OpGen, Inc. operates as an early commercial stage company using molecular testing and bioinformatics to assist healthcare providers to combat multi-drug-resistant bacterial infections. It offers Acuitas multi-drug-resistant organisms (MDRO) gene test, a molecular screening tool that detects 10 critical MDRO genes from 1 patient swab. The company also provides Acuitas CR Elite Test, which adds the ability to procure a standard microbiological culture result that provides additional information about the identified MDRO gene and its antibiotic susceptibility profile. In addition, it develops Acuitas Lighthouse MDRO bioinformatics product, which focuses on providing MDRO molecular information a...

708 Quince Orchard Road

Suite 160

Gaithersburg, MD 20878

United States

Founded in 2001

29 Employees

Phone:

301-869-9683

Fax:

301-869-9684

Key Executives for OpGen, Inc.

Executive Chairman, Chief Executive Officer and Member of Compensation Committee
Age: 57
President
Age: 47
Interim Chief Financial Officer
Age: 55
Vice President of Business Development & Operations
Age: 51
Senior Vice President of Research and Development
Age: 54
Compensation as of Fiscal Year 2014.

OpGen, Inc. Key Developments

OpGen, Inc. Announces Executive Changes

OpGen, Inc. announced the expansion of its executive management team with the appointments of former Foundation Medicine executive Kevin Krenitsky, as president, and Timothy C. Dec as interim chief financial officer. With more than 15 years of experience leading and managing global diagnostic and biotechnology operations, including senior commercial and operational responsibilities at Foundation Medicine, Dr. Krenitsky will oversee the rollout of OpGen's Acuitas MDRO (Multi-Drug Resistant Organisms) family of Gene Tests and Acuitas Lighthouse MDRO Management System in development. Through December 2014, Dr. Krenitsky was chief commercial officer and previously chief operating officer of Foundation Medicine. He joined Foundation in June 2011 and was instrumental in taking the company from a start-up organization to a successful IPO in 2013. Prior to Foundation Medicine, Dr. Krenitsky served as president of Enzo Clinical Labs, where he instituted a comprehensive strategic and operational plan that led to the introduction and launch of numerous FDA-approved esoteric tests, as well as several new laboratory developed tests. He served as chief executive officer at both BioServe Biotechnologies and Parkway Clinical Laboratories. Dr. Krenitsky also held various senior-level positions within Genomics Collaborative, Inc. (a SeraCare Life Sciences Company). Mr. Dec has more than 20 years of public company financial leadership experience in technology and healthcare, and will be charged with ensuring a smooth transition for OpGen from private to public company status and with public company reporting responsibilities. Mr. Dec has served in Chief Financial Officer or other senior financial executive roles at companies in a number of industries, including three publicly traded companies listed on NASDAQ or AMEX, such as Corvis Corporation, and at private equity-backed companies. Prior to joining OpGen, Mr. Dec served as Senior Vice President and Chief Financial Officer for Clubwidesports, LLC, from January 2014 to April 2015. From August 2007 to December 2012, Mr. Dec was Senior Vice President and Chief Financial Officer of Fortress International Group, Inc. Mr. Dec also has public accounting firm experience. He is an adjunct professor at Mount St. Mary's University in Emmitsburg, Maryland, where he teaches M.B.A. courses in Finance.

OpGen, Inc. Auditor Raises 'Going Concern' Doubt

OpGen, Inc. filed its Annual on Jan 16, 2015 for the period ending Dec 31, 2013. In this report its auditor, Ernst & Young LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern.

OpGen Launches First “Superbug” Molecular Screening Test to Identify Seven Critical Antibiotic Resistant Genes

OpGen announced that it has launched a new molecular-based test that can quickly and reliably identify patients at risk for harboring serious disease-causing microbes that can resist even the strongest antibiotics. The Acuitas MDRO Gene Test is a comprehensive molecular screening tool that can directly detect as many as seven genes from one patient sample, and will help hospitals and public health officials combat some of the most critical multi-drug resistant organisms (MDROs) threatening patients in healthcare facilities. Unlike current microbe detection methods based on growing cells in laboratory culture (a process that can take up to four days and can miss patients at risk for being colonized), the Acuitas test uses highly sensitive molecular technology to detect antibiotic resistant genes within 24 hours. It can distinguish specific genes that may aid in therapeutic guidance. Molecular technologies have been shown to have sensitivity greater than 95%, better assuring that at-risk patients are not missed. The Acuitas MDRO Gene Test is currently performed at the CLIA-certified OpGen Clinical Services Laboratory in Gaithersburg, Maryland. The Acuitas MDRO Gene Test uses DNA amplification and detection technology to detect genes associated with some of the world’s most deadly bacteria. Among these bacteria are carbapenem resistant enterobacteriaceae (CRE) containing KPC, NDM-1, and OXA-48 genes. They are resistant to nearly all antibiotics including carbapenems, a broad spectrum class of antibiotics considered to be the last resort for serious gram-negative bacterial infections. In critical care settings, death rates from KPC patients often exceed 50%. In 2013, The Centers for Disease Control (the CDC) identified CRE infection as an urgent public health threat requiring immediate and aggressive action.

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