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OpGen Provides Details on MDRO Testing Initiative, AdvanDx Tech Plans


NEW YORK (GenomeWeb) – OpGen is preparing to launch an initiative involving a number of yet-to-be-named hospitals in the US that will see its testing suite used to screen vulnerable patients for the presence of multi-drug resistant organisms (MDROs), giving physicians advance notice of the possibility of infection and the chance to take appropriate measures to forestall the spread of disease within hospital systems.

OpGen President Kevin Krenitsky spoke about the project during last week's conference call to discuss OpGen's second quarter financial results. Krenitsky, who joined the company officially in June, said during the call that hospitals involved in the multi-center project will use the company's Acuitas MDRO gene test and the Acuitas Lighthouse MDRO management system. Krenitsky also said on the call that OpGen will perform whole-genome sequencing on all samples that test positive for the presence of MDRO genes. This will be for research purposes, and OpGen will add this information to its Lighthouse database.

In a conversation following the Q2 call, Krenitsky told GenomeWeb that the project could launch next month, and at that time OpGen will publicly disclose the location of the study and which hospitals are involved. For now, the company is not providing details about the identities of the participants although Krenitsky did say that a total of 12 hospitals have signed on and OpGen expects to test well over 1,000 patients over the eight-week project — the company is charging an undisclosed capitated fee for the use of its tests.

Specifically, physicians will test asymptomatic patients who are at high risk of being colonized by drug-resistant bacteria, Krenitsky said, including individuals in intensive care units, patients with cancer, and patients with compromised immune systems. The goal is to identify which patients already carry these antibiotic resistance genes and to try to prevent full-blown infection. "[Its] about finding out what the prevalence [is] of these resistance genes in the population and ... figur[ing] out how to prevent these things from becoming a problem," he said.

The Acuitas MDRO gene test is designed to detect the presence of about 10 antibiotic resistance genes in patient samples. OpGen's testing portfolio also includes the Acuitas Resistome test, which detects 49 genes and over 900 subtypes associated with antibiotic resistance; and the Acuitas CR Elite test, which is used to confirm the presence of carbapenem-resistant Enterobacteriaceae — both of these tests provide a more detailed look into positive cases that are identified by Acuitas MDRO. For testing, the company extracts DNA from peri-anal swabs sent to its Gaithersburg, Maryland-based CLIA laboratory and uses a microfluidic PCR array to identify the relevant resistance genes in the data.

The Acuitas Lighthouse MDRO management system is a database of MDRO profiles that includes a system for tagging, tracking, and matching samples to antibiotic susceptibility and resistance data, among other features. It also includes a portal through which physicians can review individual test results, aggregate data, and compare the MDRO prevalence across hospital systems and regions.

PNA FISH plans

During last week's call, Krenitsky also touched on OpGen's plans for the technology it acquired in July along with molecular diagnostics firm AdvanDx. He said that the purchase not only expanded OpGen's customer base but also "affords us the ability to tailor some of our deep molecular resistance assays to the backend of AdvanDx QuickFISH results to provide rapid pathogen detection as well as comprehensive analysis of resistance genotypes." The company also signed an agreement with Fluidigm in July to develop diagnostic tests for MDRO genes based on Fluidigm's Juno instrument for automating SNP genotyping assays and its Biomark real-time endpoint PCR system. 

AdvanDx uses a proprietary Peptide Nucleic Acid Fluorescence In Situ Hybridization (PNA FISH) technology platform to identify pathogens in positive blood cultures. During the call, Evan Jones, OpGen's chairman and CEO, said that under OpGen, AvanDx will continue all ongoing development efforts on its products including work on a multiplex organism ID test for 18 bacteria and fungi, expected to launch in 2017, and an automated digital slide reader to help process slide-based tests and automate FISH imaging steps.

In response to an analyst's question about comparisons between OpGen's offerings and those offered by GeneWeave BioSciences — which is being acquired by Roche for up to $425 million — Jones noted OpGen already has FDA-approved organism ID tests through its purchase of AvanDx. He also pointed out that OpGen's resistance test is a genotype-driven test meaning that rather than looking for susceptibility to individual antibiotics, "we give all the information for classes of drugs." Ultimately, he said, there is room for multiple players in the market.

In addition to its testing portfolio, OpGen continues to offer its Argus human genome mapping solutions and will continue to do so, Krenitsky told GenomeWeb. He also said that the company is discussing next steps for the Argus offering with current users.