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Roche Unveils Upgraded GenMark Eplex MDx Platform at ESCMID Global


BARCELONA, Spain – After its 2021 acquisition of GenMark Diagnostics for $1.8 billion, Roche has upgraded the firm's flagship Eplex platform with new software and workflow components. 

The platform, which was officially launched here at the European Society of Clinical Microbiology and Infectious Diseases global congress (ESCMID Global) this week, has been rebranded the Cobas Eplex platform with enhanced usability, reliability, and quality control features, although the core technology and test menu have remained the same. 

According to Jeremy Kiger, the head of product strategy and international business at GenMark, the user interface and software components have been upgraded to be more intuitive for users and more responsive. Quality control is now able to be tracked and monitored via the instrument, and epidemiology reports can be generated directly from the instrument, while users can create customizable comments attached to results that can provide additional information to clinicians about treatment options. 

In addition, the ability to repair and service instruments has been improved. If one portion of the instrument needs to be serviced, it can be taken offline and fixed while the other portions of the instrument continue to operate and run tests, Kiger said. Some components of the platform are also "much easier now to repair on-site and take less time to repair, as well," he added. 

But because the core technology is the same, the existing regulatory approvals for Eplex — namely, 510(k) clearance from the US Food and Drug Administration and CE marking — are still applicable and don't need to be updated. "The improvements are more [about] look and feel, serviceability, usability, and software … that don't change the underlying detection technology that we use," Kiger said. 

The core features, such as how the instrument performs and its underlying technology, have stayed consistent because GenMark is "dedicated to the syndromic approach" and remains focused on infectious diseases, namely respiratory and bloodstream infections. The platform's test menu currently includes a respiratory virus panel that detects 20 pathogens, including influenza, SARS-CoV-2, and respiratory syncytial virus, and bloodstream infection panels that detect Gram-positive and Gram-negative bacteria, as well as fungi. 

The Roche subsidiary has "several" panels in development, Kiger said, including a gastrointestinal panel and tests for meningitis and encephalitis. Those areas were chosen because they are "high in medical value," with a clear market available, Kiger noted. 

The core markets Eplex will play in remain largely the same, with a focus on hospitals, but if there are "other areas where we feel like we can provide value to customers and patients, we'll certainly access that," Kiger added. The firm wants to be in spaces where syndromic testing is needed, he added. 

Kiger noted that Roche's Cobas brand is "recognizable" and known for quality and accuracy, and the Eplex "fits very well with that brand image." The Cobas brand name allows the instrument to be "a bit more present in some markets," Kiger added. The Eplex platform also fits well into the Cobas portfolio as a lower-throughput molecular instrument that can slot in next to Roche's larger high-volume Cobas 6800/8800 instruments or alongside its Liat point-of-care platform. 

"There's no need to try to stretch what we have within the portfolio to try to fit a need that maybe we can't serve as well," Kiger said. "With these three solutions, especially in the molecular space, we can cover all segments, all customer types." 

Before its acquisition, GenMark had a direct sales team in the US, but its overseas presence was focused on distribution agreements to expand the Eplex's reach. However, it now has direct access to Roche's sales network and marketing teams, meaning the firm's "ability to gain access to those markets, those customers … with a really highly trained sales force and marketing team is going to be incredible for us," Kiger said. Now that GenMark is under the Roche umbrella, its platform and tests can be carried, marketed, and sold globally through Roche's resources. 

Right now, GenMark's focus with the updated instrument is on the US and countries in Europe where CE marking is recognized, but it has plans to roll out its products in Asia, as well, Kiger said. 

The acquisition also accelerated GenMark's growth, as it was able to invest millions into employing new talent, improving its manufacturing process, and expanding its research and development activities, Kiger said. 

The subsidiary is also paying "close attention" to its pricing structure and strategy because it wants to ensure its solutions are available in all markets equitably, although Kiger noted that he doesn't see a "massive shift" in its existing pricing strategy as a result of the acquisition. 

"With these resources, the commitment from Roche, we're more confident than ever that we can deliver on the promise that we have with GenMark," he said.