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Meridian Prepares to Make Strides in Dx Business With Two New Instruments


NEW YORK – As Meridian Bioscience goes about rebuilding its molecular diagnostics business, the company is simultaneously implementing plans to strengthen its non-molecular testing franchise with two new instruments along with new assays for them.

For the past few years, the Cincinnati-based firm's diagnostics revenues have been on the retreat, in part because of softness in its molecular diagnostics business. But as Meridian works to fix that, a process that the company has acknowledged may last through this year, it also is looking to build out its immunoassay and clinical chemistry systems.

On the immunoassay front, Meridian's new analyzer, called Curian, is currently in front of the US Food and Drug Administration for review, with a decision on approval expected to come this quarter, CEO Jack Kenny said during the company's recent first quarter earnings call.

Meanwhile, he further noted in an interview that the company's PediaStat instrument for use in pediatric settings will be submitted to the FDA after the Curian receives approval.

Meridian submitted the Curian to the FDA in October of last year, along with its HpSA assay for H. pylori infection diagnosis, but following a request by the agency for changes to the instrument's electromagnetic compatibility testing, the company is resubmitting the instrument to the FDA, Kenny said. 

The Curian's technology leverages a fluorescent lateral flow method rather than a colorimetric-based method that results in improved limit of detection and increased sensitivity, according to Kenny. Additionally, the instrument reduces the subjectivity inherent in test interpretation by using algorithms to standardize results, he said.

Meridian already has an H. pylori test on the market under its Premier enzyme immunoassay brand, but Kenny said the company anticipates going to its current customers and offering to move them to the Curian for the rapid immunoassay H. pylori test. The move, Kenny said, is a "defensive" one, meant to put the Curian platform in the minds of users as quickly as possible, protecting Meridian from competition and increasing adoption of the system. Otherwise, "we don't see a big financial impact in the short term for HpSA," he said.

Meridian's plan for the instrument's menu revolves largely around gastrointestinal conditions, with a C. difficile assay planned as the next test after the HpSA assay is FDA approved. The company expects to submit the C. difficile assay to the FDA toward the end of its fiscal third quarter. The current strategy is to push the Curian instrument out with the HpSA assay so there's a solid installed base when the C. difficile assay comes out, Kenny said.

Also planned are assays for Enterohemorrhagic E. coli and Campylobacter enteritis, and the company is actively looking at other gastrointestinal and respiratory diseases, Kenny said. "The whole idea is to put as many assays out there on our different systems as possible," added Tony Serafini-Lamanna, Meridian's global VP and general manager for diagnostics.

The strategy, known internally as the "Meridian Multiplier," emphasizes dual platforms for customers — one molecular instrument, the Revogene, and one rapid immunoassay analyzer, the Curian, said Serafini-Lamanna.

But the platforms aren't the main emphasis. "We're not taking a platform-centric strategy, we're taking more of a disease state-centric strategy," Kenny said. By providing multiple testing and instrument options, including a multiplex gastrointestinal disease panel and individual disease assays, Meridian is attempting to respond to appropriate testing levels for each customer, depending on the audience they serve and their volume needs. For example, a hospital with hundreds of patients can use the multiplex panel to run multiple tests and get answers more quickly, while a smaller health system can use individual disease tests per patient.   

Furthering its goals to expand in the gastrointestinal disease market, Meridian announced this week it acquired Exalenz Bioscience, a breath-based diagnostic company with an emphasis on gastrointestinal and liver conditions. Exalenz's chief platform is the BreathID, a point-of-care urea breath test to diagnose H. pylori. Brian Weinstein, an analyst for William Blair, said in a note that the purchase "allows management to be aggressive and adds an option to expand and grow its presence in a category that is currently shifting away from blood-based testing."

The Revogene, which Meridian acquired when it bought GenePOC last year and has since taken over as the company's main molecular offering for bigger volume assays, had 114 placements at the end of the first quarter, Kenny said on the earnings call.

The company is also using its multiple instruments to cater to the varied needs of various health systems, Kenny said. Different testing capabilities are required at different sites within a healthcare system, so the goal is to work within the entire system to provide the instrument each site needs, depending on the size of the hospital and the patient mix it serves.

Both the Revogene and Curian have small footprints, which Kenny touted as a selling point. "We're really trying to help people to be able to decentralize some of this type of testing, and very often, when you're decentralizing testing, space is at a premium," he said, adding Meridian is specifically aiming to provide large system capabilities in small instruments.

Ease of use is another central selling point for both the Revogene and Curian instruments, Serafini-Lamanna said. Labs don't need to add an extra computer to receive results from the instruments, because both have internal computers, he said. Instead of a manual rapid test, the Curian will move to an automated read with assay-to-assay sample prep and procedures.

Meantime, in the pediatric testing space, Meridian is actively developing its PediaStat Blood Lead Testing System to run a variety of tests in the pediatrician's office, primarily its LeadCare II test. It uses electrochemical technology to determine the concentration of lead in human blood specimens, although other assays, for measuring hematocrit, bilirubin, and cholesterol levels, are also being developed for use on the platform. The current LeadCare II device was developed by Magellan Diagnostics, which was acquired by Meridian in 2016.  

The PediaStat is meant to centralize testing for pediatricians on one unit, instead of multiple units in the office, Kenny said. He also noted that the pediatrics market is underserved, since many companies don't develop tests or instruments specifically for the pediatrician's office — instead, they build products for the general market and sell them to pediatricians as an afterthought. That's where the PediaStat can come in, as a device focused specifically on the pediatrician's office, with input from from pediatricians about which tests are most important to them, Kenny said. Although it's primarily a point-of-care platform, Meridian said it's building the analyzer to be flexible enough to work in a health system's core laboratory setting.

The company's ultimate goal, once the Curian and PediaStat instruments are FDA-approved, is to have active programs on all three of its instruments, and get multiple assays approved every year, Kenny said. In addition to the Revogene, Meridian also has the Alethia molecular instrument for smaller volume assays, although Serafini-Lamanna mentioned the company's R&D focus won't be on new assays for the Alethia.

Meridian's diagnostic business has recovered slightly from its previous freefall, with this quarter being the fourth consecutive quarter with diagnostics revenues above $33 million, but Kenny emphasized there is still more work to do. The company doesn't expect significant financial impacts from either of its new instruments until at least 2021, and fiscal year 2020 is more of year to build growth, he said on the earnings call.

"We had to kind of jump-start things and come from a cold stop and get running," Kenny said. "We're making good progress but we've still got some work to do."