Kristie Wallis  (Media)
Pure Communications, Inc.
(646) 320-3845

Gaithersburg, Md.—May 16, 2013— OpGen, Inc. today announced that new data on the utility and application of its Whole Genome Mapping™ technology in the public health and health care settings will be highlighted at a company-sponsored symposium and poster presentation during the American Society for Microbiology (ASM) 113^th General Meeting. The meeting is being held May 18-21, 2013 at the Colorado Convention Center in Denver. OpGen will be exhibiting at booth #1216 during the conference.

Mike Miller, Ph.D., Associate Director for Laboratory Science (Retired) for the National Center for Emerging and Zoonotic Infectious Diseases, CDC, will present new data on OpGen’s Whole Genome Mapping technology during a poster presentation on Monday, May 19, 2013. The poster titled “Whole Genome Mapping for the Analysis of Bacterial Strains from Foodborne Outbreaks” will highlight the application of the technology in the analysis of food-borne pathogens. The poster provides an overview of the utility of Whole Genome Mapping to quickly analyze and map a multi-state outbreak of Salmonella ser. Typhimurium associated with contaminated peanut products.

Additionally, OpGen will host a symposium titled “Complete, High Resolution Whole Genome Mapping Applications in Public and Health Care Settings” on Sunday, May 19, 2013 at 7 p.m. M.D.T. at the Hyatt Regency in Denver. The symposium will feature presentations by Dr. Miller; Jack A. Gilbert, Ph.D., principal investigator, Hospital Microbiome Project at Argonne National Laboratory; and Bart Weimer, Ph.D., Director, 100K Pathogen Genome Project, Director, BGI@Davis and Director, Genomics Integration Core at West Coast Metabolomics Center at the University of California, Davis.

GAITHERSBURG, MD 

OpGen, Inc. is a leading innovator in rapid, accurate genomic and DNA analysis systems and services. The company has developed a platform, The ARGUS® Whole Genome Mapping System and also offers MapIt® Services that provide high resolution, whole genome restriction maps for sequence assembly and finishing, strain typing and comparative genomics in the life sciences market. This proprietary de novo technology is free from the limitations of gel, PCR and sequencing-based methodologies, and expansion of Whole Genome Mapping technologies to large genomes and clinical diagnostics is currently in development. OpGen’s customers include leading genomic research centers, biodefense organizations, leading genomic research centers, academic institutions, clinical research organizations and biotechnology companies.

OpGen is committed to supporting our Customers as valued partners by creating long-term relationships and continually exceeding their expectations. OpGen employees have created the company’s success. As a result of that success, we are seeking individuals who enjoy a challenge and desire to be part of a team making a difference in healthcare outcomes.

Position Summary

We are seeking a Clinical Laboratory Medical Technologist responsible for day-to-day performance of routine and non-routine laboratory tests (diagnostic and academic research) including high complexity testing in a Clinical laboratory environment. This is an opportunity to contribute to a cutting edge clinical genomics laboratory dedicated to diagnosis and epidemic analysis of healthcare associated infections.  This individual will be responsible for specimen handling and processing, testing, analyzing and recording all test results in a timely manner, conducting quality control, and adhering strictly to standard operating procedures established at OpGen, Inc.  This is an opportunity to contribute to a cutting edge clinical genomics laboratory dedicated to diagnosis and epidemic analysis of healthcare associated infections.

Primary Job Functions

• Follow the laboratory’s procedures for specimen handling and processing, test analyses, reporting and maintaining proper records of all test results
• Analyze specimens using approved and signed standard operating procedures
• Ensures operation of analyzers, incubators, centrifuges, thermocyclers, Roche cycler, PGM and other laboratory equipment by calibrating; completing preventive maintenance requirements; following manufacturer’s instructions; troubleshooting malfunctions; calling for repairs and  maintaining equipment inventories
• Ensures  reagents/test kits have received dates, expiration dates, and all records are maintained following policies and procedures established
• Maintains laboratory supplies inventory by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies
• Follow CLIA, HIPAA, OSHA, and safety guidelines as described in their respective guidelines
• Ensure compliance with safety policies and procedures in the work area and use applicable protective equipment at all times to prevent exposure to potentially infectious agents
• Adhere strictly to quality control guidelines and document all quality control activities to ensure integrity of laboratory specimens and accuracy of test results
• Follow the laboratory’s established policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance
• Identify problems that may adversely affect test performance or reporting of test results, correct the problems encountered or immediately notify the  Lab supervisor.
• Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications
• Maintain complete records of all testing performed on-site and send-outs as applicable
• Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens
• Train and implement  new or revised tests and procedures, ensuring quality control in accordance with SOPs and validation performance standards
• Participate in any additional training/educational seminars to meet regulatory  requirements and standards
• Participate in all applicable safety training sessions. Know the location and contents of the safety manual. Know the location/use of all applicable safety equipment
• Participate  in government or regulatory agency inspections as required
• Perform additional duties as directed by Lab supervisor

Education/Skills/Attributes Required

• BS  in Medical Technology, Microbiology, Biology, Chemistry or Clinical laboratory science from an accredited institution
• Significant knowledge and experience in culturing of microbes  in a BSL-2 environment is  required
• Minimum 1-2 years of  clinical laboratory experience performing high complexity testing services would be preferred
• ASCP (American Society of Clinical Pathology) generalist certification or specialist in Molecular Biology (MB), Certified Medical Technologist, or equivalent license highly desired
• Meet all credential requirements for CLIA as a Laboratory Technologist/Testing Personnel
• Previous molecular diagnostics experience including DNA isolation, PCR, RFLP, Real-Time PCR, Capillary electrophoresis and DNA sequencing is required
• Experience with  writing and editing laboratory Standard Operated Procedures (SOP) and policies is required
• Compliance experience with regulatory agencies such as CLIA, NYS and CAP would be preferred
• Operation and preventive maintenance of Lab equipment including but not limited to Thermocycler, Light cycler, Sequencing instruments etc. 
• Demonstrated proficiency in computer skills related to laboratory information systems (LIMS)
• Demonstrated proficiency in analysis software for genome related projects
• Strong PC skills, including experience with Microsoft Word, Excel, PowerPoint and Outlook
• Must have demonstrated verbal and written communication skills
• Ability to communicate effectively and courteously with people within the laboratory
• Maintains and fosters a spirit of cooperation and team effort  to accomplish results
• Quantitative analysis skills related to assay quality metrics and  performance—sensitivity, specificity, accuracy, false positive and false negative evaluations
• Ability to create and interpret statistical data reports and/or charts on assay TAT, repeat rates, quality metrics of assay performance, etc. using LIMS
• Excellent lab bench and organization skills
• Ability to work independently in the laboratory with flexibility, adaptability, efficiency, accuracy and professionalism
• Accountability for personal decisions, actions and results related to laboratory testing performance
• Position may require sustained periods of standing, sitting and work using a computer monitor as well as lifting up to 25 lbs 
• BSL2 laboratory environment handling human specimens of all types including infectious disease agents

Qualified applicants should submit a cover letter and resume to JOBS@opgen.com indicating JOB CODE: CLMT in the subject heading.  OpGen is an Equal Opportunity Employer.

Complete, High-Resolution Whole Genome Mapping Applications
in Public Health and Health Care Settings

May 19, Sunday
7:00 PM

Hyatt Regency Denver
650 15th Street
Mineral B&C 

Whole Genome Mapping: A new paradigm for strain typing in public health settings
Dr. Mike Miller
Microbiology Technical Services, LLC

The Hospital Microbiome Project: Tracking microbial life by comparative genomics
Dr. Jack A. Gilbert
Principal Investigator, Hospital Microbiome Project
Argonne National Laboratory

The 100K Genome Project/OpGen Partnership: Large-scale, highly-curated genomes
Dr. Bart Weimer
Director, 100K Pathogen Genome Project
Director, BGI@Davis
Director Genomics Integration Core, West Coast Metabolomics Center
University of California, Davis

Register

[contact-form-7]

Grand Ballroom 1, Table 7

Poster: P039 

Accurate Characterization of the Drosophila Genome Using Whole Genome Mapping Technology

Zhou, et al.

Provide your contact details below so that we can schedule time to speak with you.

[contact-form-7]

GAITHERSBURG, MD 

 OpGen, Inc. is a leading innovator in rapid, accurate genomic and DNA analysis systems and services. The company has developed a platform, The Argus® Whole Genome Mapping System and also offers MapIt™ Services that provide high resolution, whole genome restriction maps for sequence assembly and finishing, strain typing and comparative genomics in the life sciences market. This proprietary de novo technology is free from the limitations of gel, PCR and sequencing-based methodologies, and expansion of Whole Genome Mapping technologies to large genomes and clinical diagnostics is currently in development. OpGen’s customers include leading genomic research centers, biodefense organizations, leading genomic research centers, academic institutions, clinical research organizations and biotechnology companies.

 OpGen is committed to supporting our Customers as valued partners by creating long-term relationships and continually exceeding their expectations. OpGen employees have created the company’s success. As a result of that success, we are seeking individuals who enjoy a challenge and desire to be part of a team making a difference in healthcare outcomes.

 Position Summary

We are seeking a Clinical Laboratory Supervisor/Manager responsible for day-to-day supervision and oversight of high complexity (both diagnostic and academic research) testing services in a Clinical laboratory environment. The Supervisor will manage routine and complex Molecular Biology procedures including training/ implementation of assays and analyzing /interpretation/reporting of test results. This individual will be responsible for supervising assigned Medical Technologists and Laboratory Associates for routine Clinical Lab Services, ensuring adherence to all regulatory standards and will be accountable for both quantity and quality of test results.

Primary Job Functions

• Manage the daily operation of assigned laboratory group to ensure that specimens are properly shipped and received, tests are performed accurately and efficiently, and results are reported in a timely manner
• Perform pre-analytical, analytical and post analytical test process and evaluate results generated relative to the diagnostic assessment independently and/or in coordination with Laboratory Director
• Evaluate data for accuracy and verify questionable findings with proper documentation, thorough investigation, and appropriate follow-through.
• Assist with designing processes and procedures to ensure efficient turn-around time and accuracy of results
• Engage in continuous process and service improvement. Make and implement recommendations to improve operational efficiency and implement new services for areas of responsibility
• Manage strict adherence to quality control guidelines to ensure integrity of laboratory specimens and accuracy of results
• Ensure all work is in accordance with state and Federal regulations, organizational policy, and accreditation/compliance requirements
• Assist in developing and securing CLIA (MD State), NYS, CAP and other accreditations
• Ensure compliance with safety policies and procedures in the work area and use applicable protective equipment at all time to prevent exposure to potentially infectious agents
• Coordinate training and implementation of new or revised tests and procedures, ensuring quality control in accordance with SOPs and validation performance standards
• Perform duties of technologist as necessitated by absence or peak workload
• Complete special projects as requested by senior staff e.g. statistical reports, studies, research, etc
• Responsible for management of laboratory staff  (Map-It and CLIA services) including, but not limited to, hiring, orientation, training, coaching, annual evaluations, documenting performance and disciplining  to ensure a well-qualified team and to enhance operational success
• Oversee Map-IT, CLIA and microbiology operations, control and coordinate all functions
• Manage any and all test system deviations from established performance specifications by taking remedial actions in a timely manner
• Prepare and maintain all personnel credential files to meet regulatory standards and for inspections
• Coach and mentor staff on technical expertise and carry out evaluation of employee competencies
• Prepare and manage laboratory budget within constraints and limitations as applicable

 Education/Skills/Attributes Required

• BS or MS in Medical Technology, Biology, Chemistry or related scientific discipline
• Minimum of 5-7 yrs(BS) or 3-5 yrs(MS) related experience, 2 years at supervisory level in a clinical laboratory performing high complexity testing services
• ASCP (American Society of Clinical Pathology) generalist certification or specialist in Molecular Biology (MB), Certified Medical Technologist, or equivalent license highly desired
• Eligible for certification by CLIA as a Laboratory General Supervisor. 
• Previous molecular diagnostics experience including DNA isolation, PCR, RFLPReal-Time PCR, Capillary electrophoresis and DNA sequencing is required.
• Knowledge and experience in culturing of microbes  in a BSL-2 environment is  required
• Knowledge of regulatory requirements for molecular diagnostic test development, commercialization and post launch support is required
• Experience with accreditation inspections and writing and editing laboratory Standard Operated Procedures (SOP) and policies is required
• Compliance experience with regulatory agencies such as CLIA, NYS and CAP would be preferred
• Operation and preventive maintenance of Lab equipment including but not limited to Thermocycler, Light cycler, Sequencing instruments, Mapping instruments etc 
• Demonstrated proficiency in computer skills related to laboratory information systems (LIMS)
• Demonstrated proficiency in analysis software for genome related projects
• Strong PC skills, including experience with Microsoft Word, Excel, PowerPoint and Outlook
• Must have excellent verbal and written communication skills as well as demonstrated customer relations skills 
• Must be able to deal with sensitive issues effectively, maintaining confidentiality and good relationships both in the office and with employees across the company
• Ability to communicate effectively and courteously with people at different levels within the organization
• Ability to communicate tactfully with vendors, customers, and others seeking information, and relay their requests and information to the proper personnel effectively
• Quantitative analysis skills related to assay quality metrics and  performance—sensitivity, specificity, accuracy, False positive and False negative rates
• Ability to create and interpret statistical data reports and/or charts on assay TAT, repeat rates, quality metrics of assay performance, etc using LIMS
• Excellent leadership and organization skills.
• Strong team player who thrives in a team environment and presents themselves in a polished professional manner.
• Ability to work independently with flexibility and with adaptability, efficiency, accuracy and professionalism.
• Strong planning and organizing skills with the demonstrated ability to multi-task, manage multiple priorities and changes in priorities with professionalism
• Accountability for personal decisions, actions and results.
• Must be willing to work as required for the efficient operation of the business.  Must be resourceful in resolving problems.
• Position may require sustained periods of standing, sitting and work using a computer monitor as well as lifting up to 25 lbs. 
• BSL2 laboratory environment  handling human specimens of all types including infectious disease agents

 Qualified applicants should submit a cover letter and resume to JOBS@opgen.com indicating JOB CODE: LSM in the subject heading.  OpGen is an Equal Opportunity Employer.

GAITHERSBURG, MD  

 OpGen, Inc. is a leading innovator in rapid, accurate genomic and DNA analysis systems and services. The company has developed a platform, The Argus® Whole Genome Mapping System and also offers MapIt™ Services that provide high resolution, whole genome restriction maps for sequence assembly and finishing, strain typing and comparative genomics in the life sciences market. This proprietary de novo technology is free from the limitations of gel, PCR and sequencing-based methodologies, and expansion of Whole Genome Mapping technologies to large genomes and clinical diagnostics is currently in development. OpGen’s customers include leading genomic research centers, biodefense organizations, leading genomic research centers, academic institutions, clinical research organizations and biotechnology companies. 

OpGen is committed to supporting our Customers as valued partners by creating long-term relationships and continually exceeding their expectations. OpGen employees have created the company’s success. As a result of that success, we are seeking individuals who enjoy a challenge and desire to be part of a team making a difference in healthcare outcomes. 

Position Summary                                                        

This position will be the lead position in Manufacturing Quality Assurance that will be responsible for compliance to cGMP within Operations. The scope of the position will also include Document Control activities such as processing new documentation, revising existing documentation and managing the document control system. This position will also serve as backup for testing and release of product during periods of high production activity. 

Primary Job Functions 

• Insure that all activities performed within Operations are performed in a manner consistent with cGMP requirements.
• Conduct audits of practices within operations to insure compliance with cGMP requirements.
• Conduct training sessions on cGMP principles and guidelines.
• Conduct audits of equipment and facilities used in the manufacturing and testing of product to insure fitness for use. Insure calibration of equipment used in the manufacture and testing of product is current.
• Monitor temperature of refrigerators, freezers and controlled work areas to insure spec limits are being maintained.
• Monitor water quality on a daily basis and test weekly to insure specs are being maintained.
• Manage the Document Control system to insure that only current, approved documents are used in the manufacture and testing of product. Manage the Change Control process for existing documents and insure that all issues are addressed in a timely manner and that all signatures are obtained in a timely manner. Modify existing documents and create new documents as required.
• Review all documentation, including Batch Records for accuracy and completeness prior to filing. Control the storage of batch records to insure that completed records are not misplaced.
• Work with Product Support on monitoring customer complaints and identifying when corrective actions are required. Similarly monitor practices within Operations and identify when corrective actions are required to improve control. Issue CAR’s and CAPA’s as required to address improvements needed and track through to completion.
• Back up QC testing as required in analytical testing on reagents, functional testing on components and kits, inspection and testing of incoming materials and the like.  

Education/Skills/Attributes Required

• BS/BA degree in chemistry, biochemistry, molecular biology or a related discipline preferred. 4 yr college degree, preferably in Science, required. At least 3 yrs experience in performing QA activities in an FDA regulated environment required. Experience in leading QA activities is highly desirable. Work experience must show an emphasis on the QA function and a proclivity to continue in a QA role.
• Must be thoroughly knowledgeable in cGMP requirements. Experience in training others in cGMP principles is highly desirable.
• Must be proficient in QA roles and responsibilities and able to carry out those responsibilities independently. Work history must demonstrate experience in successfully carry out the responsibilities of the QA function.
• Work experience must demonstrate knowledge of QA responsibilities and the ability to lead the QA function.
• Must have experience in auditing for GMP compliance and the ability to train others in GMP compliance.
• Document processing and managing the document control system is a significant part of the responsibilities of this position.
• Candidate must be accurate and attentive to details in their work. This position will be responsible for final and timely review of documentation and release of product.
• Familiarity with the use of Excel and graphical analysis for trending is highly desirable.
• Proficient in the use of Word-processing software packages required. Experience in the use of Excel and PowerPoint desirable.
• Excellent communication and presentation skills required for training and reporting purposes.
• Ability to interact effectively with personnel at all levels, particularly in problematic situations.
• Ability to run analytical and functional assays, collect and interpret data, required.
• This position will be required to make decisions based on documentation provided that will ultimately determine whether product will Pass or Fail.  These decisions will have direct impact on the manufacturing activities of the company.

  Qualified applicants should submit a cover letter and resume to JOBS@opgen.com indicating JOB CODE: QS in the subject heading.  OpGen is an Equal Opportunity Employer.

OpGen Contact:
Eric Winzer
CFO OpGen, Inc.
(240) 813-1273

Major Genomics Sequencing Centers Worldwide Utilizing OpGen’s Whole Genome Mapping Technology

Gaithersburg, Md.—November 19, 2012— OpGen, Inc., a commercial stage DNA analysis company, today announced the Argus® Whole Genome Mapping System continues to gain broad adoption among genome sequencing centers worldwide. Five leading international genomic sequencing centers have joined the growing list of centers utilizing OpGen’s technology to enhance their next-generation sequencing capabilities. The centers include The Genome Institute at Washington University, St. Louis, MO; The Genome Analysis Centre (TGAC), Norwich, UK; Genoscope, Evry, France; National High-throughput DNA Sequencing Centre at the Centre for GeoGenetics, Copenhagen, Denmark; and Genome Institute of Singapore. These organizations join our growing customer base that includes Wellcome Trust Sanger Institute and BGI, public health and biodefense agencies, and research and service labs that are utilizing the company’s Whole Genome Mapping technologies and services.

“We adopted OpGen’s Argus System after evaluating the value of adding Whole Genome Mapping to improve whole genome sequences,” said George Weinstock, Ph.D., associate director of The Genome Institute at Washington University. “We combined Whole Genome Maps with sequence assemblies to correct errors and misassemblies in bacterial samples from the Human Microbiome Project, and now we are using the technology in larger genome projects.”

OpGen’s Argus Whole Genome Mapping System is the only commercially available technology that can provide a high resolution, complete visual map of a whole genome and individual chromosomes. OpGen’s unique single molecule analysis technology provides a whole genome view that compliments genome assembly and enables scientist to identify highly repetitive regions, tandem repeats and translocations that are very difficult to identify and clarify with sequencing alone. Sequencing projects can now be finished and validated with less investment in time, cost and computational effort.

“Our research focuses on a wide variety of projects from microbes to crop plants and mammals,” said Matthew Clark, Ph.D., sequencing technology development team leader at The Genome Analysis Centre. “Many of our projects are de novo assembly projects, where, without a closely related genome sequence, it can be difficult to critically assess the results. We often combine different sequencing technologies, and we are finding that regardless of the sequencing platform, error correction, or assembler used, OpGen’s Whole Genome Mapping identifies misassemblies and provides the highest quality de novo assembly for further research.”

“We are successfully expanding our customer base among major global sequencing centers,” said Douglas White, president and chief executive officer of OpGen. “By providing the highest quality, validated sequence assemblies, our goal is to enable translational research that will meet the highest standards for clinical applications.”

About OpGen, Inc.
OpGen, Inc. is a leading innovator in providing rapid, accurate genomic and DNA analysis systems and services. The company’s Argus® Whole Genome Mapping System, GenomeBuilder™ and MapIt® Services provide high resolution, whole genome maps for sequence assembly and finishing, strain typing and comparative genomics in the life sciences market. OpGen’s powerful technology dramatically improves the quality of data and time-to results by providing sequence information from single DNA molecules more rapidly and less expensively than previously possible. The company is dedicated to positively influencing individual healthcare outcomes, advancing scientific research and enhancing public health by delivering precise, actionable information and results to customers in the life science and healthcare communities. OpGen’s customers include leading genomic research centers, biodefense organizations, academic institutions, clinical research organizations and biotechnology companies. For more information, visit www.opgen.com.