Note: This article has been updated from a previous version posted Feb. 23 to clarify OpGen's CLIA lab strategy with respect to bringing Ares Genetics' products to the US.
NEW YORK – Almost five months after receiving US Food and Drug Administration clearance for its Acuitas AMR antimicrobial resistance marker detection panel, OpGen looks to drive clinical uptake of the panel.
Although Acuitas AMR was approved by the FDA in October shortly before a $15 million direct offering, the COVID-19 Omicron surge slowed its commercial rollout, which is now beginning to ramp up, according to OpGen CEO Oliver Schacht.
"We're in a very active dialogue with a significant number of potential accounts and users, and several of them are looking at clinical use cases and implementation," Schacht said in an interview.
In the meantime, OpGen has published a study establishing the panel's performance characteristics.
In that study, published in the Journal of Clinical Microbiology, Acuitas AMR detected 28 antimicrobial resistance (AMR) genes associated with non-susceptibility to nine antibiotic classes, from cultured isolates of 26 pathogens including Pseudomonas aeruginosa, Enterococcus faecalis, or select Enterobacterales species, with at least a 94.4 percent positive agreement and a 96.5 percent negative agreement to a composite reference standard, including whole-genome sequencing.
The assay offers the widest currently available set of AMR markers, with a 2.5-hour turnaround time including approximately 30 minutes of hands-on time. The assay combines multiplexed real-time PCR with bacterial species identification data included in the Acuitas AMR Gene Analysis Software. Users can simultaneously test for select drugs within nine antibiotic classes to help identify potentially antimicrobial-resistant organisms that might otherwise escape detection.
The Acuitas AMR panel has so far been used primarily by researchers and hospitals working in infection control and prevention. With the recent FDA clearance, however, OpGen expects it to gain traction as a clinical diagnostic.
Schacht said that OpGen reached out to "well over 400 institutions across the United States" over the week following the company's announcement of FDA clearance, and that the company is engaged in "active dialogue across the country from very different types of institutions."
Schacht also said that the panel's list price of $170 provides a degree of flexibility in working with potential customers to find "creative pricing models and discounting schemes" to address individual user needs.
OpGen sees considerable potential in the test's clinical utility moving forward. The JCM study demonstrated a high correlation between the panel's AMR gene results and those from the more traditional phenotypic antimicrobial susceptibility testing (AST).
The Acuitas AMR results add to AST by offering insights into a pathogen's mechanism of antibiotic resistance, an increasing area of focus for current treatment guidelines.
"This is really important because you can have a third-generation cephalosporin phenotype but [unless you] know if it's mediated by Amp C or ESBL, you're not going to know which therapy to select," Faranak Atrzadeh, OpGen's chief marketing and scientific affairs officer, said in an interview.
The information delivered by the Acuitas AMR panel complements that obtained through proteomic tests such as MALDI-TOF.
MALDI-TOF also operates on a fast turnaround time, identifying dozens of samples in as little as an hour, although identification relies upon databases containing the spectra of known organisms, leading to a potential loss of discrimination when confronted with rare organisms or highly related species.
"[MALDI-TOF] has done a very good job and pathogen ID and is very, very complementary with the Acuitas panel," Atrzadeh said. "From having an identified, isolated bacterial colony, one would run the Acuitas AMR gene panel … to detect and differentiate the presence of those 28 genes that it covers."
OpGen also applies NGS and bioinformatics strategies to AMR through its Vienna-based subsidiary, Ares Genetics, whose commercial offerings OpGen plans to bring into the US later this year.
These offerings include ARESdb, a database of over 78,000 NGS isolates with phenotypic data on over 100 antibiotics; AREScloud, a bioinformatics and reporting hub; and ARESupa, a universal pathogenome assay, which covers over 8,000 genetic AMR markers.
OpGen is currently working to create a CLIA reference lab channel to facilitate connections between Ares' products in US labs that follow CLIA guidelines.
Acuitas' select AMR panel and the NGS capabilities of Ares' products together provide clients with complementary information. While Acuitas rapidly provides clinicians with information critical to treatment decisions, tools such as ARESupa provide much more fine-grained information useful in unambiguously identifying pathogens.
"That's really the strength of NGS," Schacht said. "Assume you start seeing different patients … presenting with what at first glance looks like the same multidrug-resistant organism. You can run an Acuitas AMR gene panel and it will tell you if any of the 28 gene markers relevant to [that organism] happen to be there. But if you really want to know if this is the same bug, the same strain, you need to look at the whole genome sequence."
Such information would be relevant in identifying and tracking outbreaks, for instance.
In contrast to OpGen's plans for Ares Genetics, the company currently has no plans to export Acuitas AMR beyond the US, as the country's market for molecular diagnostics is large enough to allow continued growth and Europe's new In Vitro Diagnostic Regulation makes bringing new assays to the EU less straightforward than it had been previously.
"I'm not going to exclude also taking the Acuitas beyond the US sometime in the future," Schacht said, "but at least for now we [plan on] sticking squarely to the US, which is the only market where we have a direct sales and marketing organization."
The company reported a cash balance of $36.1 million at the end of last year, which Schacht says puts OpGen in a strong position to continue developing both Acuitas and other offerings.
This includes invasive joint infection and complicated urinary tract infection (UTI) panels, as well as updates to analyzer instruments in the Unyvero A30 RQ platform.
Developed by its subsidiary Curetis, the Unyvero A30 RQ is a PCR cartridge-based antibiotic-resistant microorganism identification system. The A30 is a smaller, faster, and cheaper version of the A50, capable of performing multiplexed real-time qPCR on up to 33 bacterial samples over up to 90 minutes, with a price target of under $10,000, compared to the roughly $50,000 A50 device.
OpGen is initiating a multicenter prospective clinical trial in the US for the UTI panel and expects to report interim data at the end of the first quarter.