OpGen helps healthcare providers respond to the challenge of antibiotic-resistant infections
Evan Jones Chairman & CEO, OpGen
Professional
Chairman & CEO since October 2013 Co-founder, Chairman & CEO, Digene Corp., 1990–2006 Managing Member, jVen Capital, LLC since 2007
Education
BA, University of Colorado, Boulder MBA, The Wharton School, University of Pennsylvania
Personal
“I am actively involved with children’s healthcare, advocating for biomedical and public health research. My hobbies include skiing, biking, hiking, golf, and sailing”
What are the primary areas of expertise of OpGen, Inc.? OpGen is focused on combating life-threatening, antibiotic-resistant infections using molecular diagnostics and bioinformatics technologies. We operate a CLIA-certified diagnostic laboratory focused on helping hospitals diagnose, prevent, and manage acute infections. The company has extensive experience in the fields of microbial genetics, molecular diagnostics, and bioinformatics, making us well positioned to become a leader in this important new field.
Our lead product is the Acuitas MDRO Gene Test for detection of Gram-negative carbapenem-resistant bacteria. The Acuitas test directly detects seven critical multi-drug-resistant organism (MDRO) genes from a single patient swab. Test results are provided to client hospitals with a 24-hour turnaround time.
How have OpGen’s solutions evolved in recent years to address changing customer needs? OpGen’s product offerings help healthcare providers combat the growing threat of antibiotic resistance. Our primary focus is helping to identify bacteria that are resistant to powerful carbapenem antibiotics. These bacteria are often called “superbugs” because they are resistant to almost all antibiotics, they spread rapidly and are difficult to detect, and they are extremely difficult to eradicate in a hospital environment. Patients with Gram-negative carbapenem-resistant enterobacteriaceae (CRE) have a death rate as high as 50%.
Detection of multi-drug antibiotic resistance is highly complex, and resistance genes are constantly changing. OpGen invests to develop state-of-the- art tests with in-depth validation of clinical performance. With centralized testing capabilities OpGen is able to provide affordable, highly accurate molecular testing to hospitals. In addition to providing rapid turnaround with the Acuitas test, we provide seven gene test results from a single patient swab along with
integrated follow-on testing that combines organism ID, antibiotics susceptibility testing, and DNA sequence-based information when needed.
OpGen offers customers genome research technology and applications, including whole genome sequencing and sequence assembly. In what clinical contexts are these most useful? Molecular testing for antibiotic resistance is an exciting new frontier in microbiology. Traditional microbiological methods rely on growth of the underlying organism. With Gram-negative bacteria it can take three to four days to fully characterize the organism phenotype and then use this information to indirectly infer the underlying genotype. With OpGen’s advanced genetic testing capabilities, this information is provided on a timely basis, and antibiotic resistance information is integrated with the molecular test results to provide a complete picture to the clinician.
How do you see the needs for information technology evolving in microbiology? Testing for single gene-resistant organisms such as MRSA represent relatively manageable information technology needs for the lab and hospital. Testing for multi-drug resistance, and then using this information to help combat hospital infections, are done most effectively with the aid of sophisticated bioinformatics technology. OpGen is developing the Lighthouse MDRO Management System to help address these needs. We anticipate the system will provide real-time detection, monitoring, and management capabilities for hospital infection threats. The system uses hospital-specific data to help track and improve outcomes. The HIPAA-compliant cloud-based data system will combine DNA test information and antibiotic resistance profiles with patient and hospital information to help rapidly identify and track dangerous multi-drug-resistant organisms, helping to guide antibiotic stewardship programs.
The Acuitas MDRO Gene Test has also received a great deal of attention. What role does this test play in the ongoing battle against superbugs? In fall 2012 the CDC issued a CRE Toolkit—Guidance for Control of Carbapenem-resistant Enterobacteriaceae. The CDC guidance calls for hospitals to perform point-prevalence surveys, testing of epidemiologically linked patients, and active surveillance of high-risk patients. The recommended testing methods rely on complicated phenotypic methods that are difficult to implement cost-effectively in most hospital microbiology labs and have relatively poor overall sensitivity and specificity. The OpGen Acuitas test addresses these needs by combining rapid, accurate, cost-effective molecular diagnostic testing for CREs and other MDROs and companion culture and phenotypic ID methods.
Studies indicate that early detection of MDROs may improve outcomes and reduce healthcare costs. Active CRE surveillance programs can detect the presence of a dangerous MDRO before it is an active infection.
Last year, OpGen opened a CLIA-certified clinical services lab and launched microbial genetic tests for HAIs. How have these activities been proceeding? Results from our initial introduction of the Acuitas test have been very encouraging. Many large healthcare systems are evaluating this new technology and others are moving forward to incorporate the Acuitas test into their infection control programs. Hospitals already screening for CRE colonization in ICUs see molecular testing as a valuable alternative to their current culture-based programs. Others are starting by conducting point-prevalence surveys to determine their level of colonization and to help design customized screening programs addressing their unique needs.
