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OpGen Prepping New Antibiotic Resistance Surveillance Tools for 2016 Launch


NEW YORK (GenomeWeb) – OpGen will soon commercialize a portal that it developed to help customers of its CLIA laboratory testing services track, visualize, and explore the results of multi-drug resistant organism (MDRO) testing and surveillance in a single interface.

The company also has plans to launch a combined product and service solution in the second half of the year for MDRO surveillance and infectious disease diagnosis in acutely ill patients.

OpGen unveiled its plans during a conference call held last week to discuss its first quarter financial results. In addition to reporting a 128 percent increase in Q1 revenues, the company also announced pricing for a private placement financing from which it hopes to raise gross proceeds of about $10.4 million that it will use to support sales and marketing and R&D for its diagnostic and bioinformatics products and services.

The portal, which OpGen will officially release this spring, is a gateway to OpGen's Acuitas Lighthouse MDRO management system, an internally built database of multidrug-resistant organism profiles that is part of the company's Acuitas Lighthouse bioinformatics suite. These are part of a larger suite of products that includes OpGen's proprietary DNA tests and the aforementioned CLIA lab services for MDRO identification and antibiotic resistance surveillance. The test menu includes the company's QuickFISH family of US Food and Drug Administration-cleared and CE-marked diagnostic products, which are used to detect pathogens in positive blood cultures; and its MDRO Gene Test for detecting, typing, and tracking antibiotic resistant organisms in real time.

OpGen's Lighthouse data warehouse and management system hosts all of the information that the company's CLIA lab generates from testing patient samples for hospitals. The repository captures metadata such as sample type and source as well as testing results. It also features algorithms for correlating genotype and phenotype information and for predicting phenotype based on genotype, as well as tools for tagging, tracking, and matching samples to antibiotic susceptibility and resistance data.

The portal will let physicians review individual test results, aggregate data, and compare MDRO prevalence across hospital systems and regions, according to OpGen. It includes a number of mechanisms for presenting data in interactive ways and lets users control how they see and explore the data in the system, Vadim Sapiro, OpGen's chief information officer, told GenomeWeb in an interview following the earnings call.

It features customizable dashboards that come with an initial set of pre-defined mechanisms for filtering data based on different parameters and criteria, Sapiro said. For instance, a clinician could create a custom dashboard for visualizing MDRO prevalence data for their hospital. That dashboard might organize data into bar graphs and charts that provide information on sample counts and sources including information on the geographic location of the patient, he said. But users could also group and visualize data according to MDRO profiles or by gene prevalence among other options. "It's a very flexible system that lets you cut the data in any way imaginable," he said.

The company does have a pricing scheme in place for access to the portal but it is not disclosing details about what those costs are. OpGen Chairman and CEO Evan Jones did note that the portal would be monetized through the use of its lab services. In other words, "in order to use the lighthouse system, you would be using OpGen CLIA lab testing services," he told GenomeWeb in a conversation after the call. However, OpGen CLIA lab clients can also access test reports through standard lab reporting mechanisms if they choose not to use the portal, the company said.

For its Acuitas MDRO Gene test product, OpGen charges $50 to $100 per test; and for the Acuitas Resistome test, the company charges $200 to $225. The exact costs depends on volume, additional follow-on testing, and other factors. OpGen reported $129,420 from lab services for Q1 of this year.

The portal has already been used for a testing initiative with the District of Columbia Hospital Association program. The so-called Healthcare Facility Antibiotic Resistance Prevalence-District of Columbia project, which launched last year, sought to gauge the prevalence of the multidrug-resistant Gram-negative carbapenem-resistant enterobacteriaceae (CRE) in health facilities in the area. 

OpGen provided an update on the testing initiative during last week's earnings call. Specifically, it said that 16 hospitals in the area used the company's testing tools to screen vulnerable patients for MDROs. The list of hospitals includes the BridgePoint Hospitals, Children's National Medical Center, George Washington University Hospital, Howard University Hospital, Providence Hospital, MedStar Georgetown University Hospital, MedStar Washington Hospital Center, Sibley Memorial Hospital, and United Medical Center. OpGen has completed testing and reporting for more than 1,000 patient samples collected from the hospitals. OpGen President Kevin Krenitsky said that the company is currently involved in discussions about next steps for the project.

That project was a good testing ground for the portal, according to Jones. Because the target market is large hospital systems, it was crucial for the company to demonstrate the efficacy of the offering prior to commercialization. "Having done that successfully, now we are ready to take that out to additional health systems," he said.

Also on the call, Krenitsky said that the company plans to launch an integrated product and service solution in the second-half of 2016. The company is not disclosing specific details about that offering at this time but Krenitsky did say on the call that a number of unnamed clients will soon begin using the solution. "The combination of OpGen's testing capabilities along with our Lighthouse bioinformatics capabilities can provide a comprehensive solution to the current issues hospitals face with the implementation of effective antimicrobial stewardship programs," he said on the call.

According to numbers quoted by OpGen from the 2015 White House Antibiotic Stewardship forum, there are 262 million antibiotic prescriptions annually, about 50 percent of which are estimated to be unnecessary or inappropriate. "The government is [now] mandating that hospitals begin to implement ... stewardship programs to ensure that they are using their antibiotics appropriately," CEO Jones said. "That's a data business. You need high-resolution lab data to enable that. That's the business that we really are trying to pioneer here." 

The company also said last week during the call that it has completed the first phase of a multi-phase health outcomes initiative that it did in partnership with an unnamed integrated health network. The project aims to demonstrate the scope and costs of MDROs to patients and healthcare providers, the company said. This first phase involved retrospective analysis of over 3 million patient health records. Later phases for the project will include real-time data generation to help clinicians manage and guide treatment decisions for MDRO patients, Krenitsky said on the call. 

Meanwhile, OpGen is also developing new diagnostic products for rapidly identifying MDROs and selecting appropriate therapies that it estimates will be ready for commercialization in 2019, according to a recently filed 10-Q document. This includes a one-hour array-based rapid antibiotic resistance test that the company has begun developing to identify infectious diseases and test for antibiotic resistance.

OpGen does not believe there are direct competitors for its products but the company's offerings do compete on some level with infectious diseases screening and diagnostic products from companies such as Cepheid, BioMérieux, and Roche's GeneWeave Biosciences. Cepheid, for instance, was recently cleared by the US Food and Drug Administration to market its Xpert Carba-R test for detecting CRE. In a recent study, researchers in Madrid demonstrated that the Xpert-Carba-R test had high sensitivity, specificity, and positive and negative predictive values for detecting CRE compared to culture followed by sequencing.