NEW YORK – Roche has been a leader in the clinical chemistry and core lab management diagnostics space for years, but changes in the industry have led to revised priorities.
In a market with so many pressures, from increasing competition to price reductions and other variables, keeping up with the changing pace can be a challenge – even when a company is as globally entrenched as Roche. Competition has heated up, in particular from Abbott, who led the core lab peer group in terms of growth over Roche, which has historically outperformed its peers, according to an research note from Barclays analyst Jack Meehan.
To address these pressures, its emphasis lately has been on integration within the lab and increasing automation throughout lab operations, according to Ann Costello, the global head of Roche's centralized and point-of-care solutions.
The company has had success in that area, with third quarter revenues in 2019 for its centralized and point-of-care business increasing 5 percent to CHF 5.77 billion ($5.79 billion). Sales for that segment also made up 61 percent of Roche's diagnostic sales in Q3 2019, and some of that revenue has come from the launch of the Cobas Pro instrument.
Since its launch at the end of 2018, Roche's Cobas Pro Integrated Solutions has received a CE mark and clearance from the US Food and Drug Administration.
Designed for clinical chemistry and immunochemistry, the Cobas Pro currently has three modules that can run up to 2,200 tests per hour. It also has two units: the Cobas C 503 analytical unit for clinical chemistry, which can perform up to 1,000 tests per hour and has 60 reagent positions, and the Cobas E 801 analytical unit for immunochemistry, which can perform up to 300 tests per hour and has 48 reagent positions, according to the company's brochure.
It also has automated maintenance and calibration, with six-month onboard stability for the reagent, Costello noted. Along with these features, Roche has plans to add more units, allowing for up to four of the same modules in whatever configuration the lab needs depending on its throughput, Costello said.
Roche isn't the only company to develop instruments with dual capability, however. Abbott, one of Roche's main competitors in the core lab space, launched its Alinity CI series system in 2017, which combines the Alinity C clinical chemistry system and the Alinity I immunoassay system into an integrated unit. Siemens Healthineers also has its Atellica Solution, which integrates immunoassay and clinical chemistry analyzers and can run up to 440 tests per hour, and Ortho Clinical Diagnostics has its Vitros 5600 Integrated System, with 120 assays.
Also currently in development at Roche is the Cobas Pure, which Costello said was a smaller version of the Cobas Pro that will be able to integrate into the lab or be used as a standalone in smaller independent labs. Because many core labs have a "hub and spoke" system, with one major lab and multiple satellite labs, the Cobas Pure is designed to work within that model.
Both the Cobas Pro and the Cobas Pure will use the same reagent kits with the same content, so the location of the patient test doesn't matter – results will be the same regardless, according to the company. The features between the two are also similar to make it easy to train and onboard customers with the new system. Costello declined to share the official timeline for the Cobas Pure's launch, but said it was "a couple of years out."
Consolidation is a major trend in the diagnostics industry overall, said Susan Morgensztern, a strategic development consultant for the industry, so it makes sense Roche and other companies would move toward combining instruments.
"Companies are looking at consolidating more into one instrument because the labs can't afford to," said Morgensztern. "We used to buy lots of instruments, but they don't have that option as much anymore."
Roche also launched another tool for core labs last month, its Cobas Mobile Solution, a tablet-based solution that allows lab professionals to interact with analyzers from anywhere in the lab and know the status of instruments regardless of where in the lab they are.
One of the key areas Roche has plans to expand automation into is mass spectrometry, which Costello noted is an area that hasn't been integrated into the core lab. Because there are multiple pieces of equipment that are usually in a separate room and require specialists to operate, it's an area that's "really ripe for automation and integration and for simplification," Costello said.
"We believe we are in a very good position to be able to take a very manual type of technology into the core lab," Costello said. The company currently has a development plan around mass spec, hoping to integrate it into the core lab with a "plug-and-play" format that's easy to use for operators, Costello said.
Simplicity is another driver of Roche's development pipeline, with Roche's instruments optimized to perform the mundane tasks of a lab independently, freeing up skilled professionals to focus on more complex activities. There's a lack of skilled personnel in labs, both Morgensztern and Costello, noted, making automation of simple tasks more important. After all, from 2007 to 2017, the workforce of US pathologists declined approximately 17 percent, according to a 2019 study in the journal JAMA.
"Labs are asked to do more with less," Costello said, "so that's why for us, as we bring on new automation, simplicity is really the key here."
Some of the "more with less" labs are being asked to do involves the regulations in the Protecting Access to Medicare Act of 2014. While many labs and diagnostic companies have bemoaned PAMA's implementation and the burden it puts on labs, Costello said the impact of PAMA isn't anything new for the diagnostics business.
"We never have a year where we don't talk about price pressure," Costello said. "That's sort of the reality of the business of IVD testing."
Instrumentation development isn't the only way Roche has plans to innovate in the core lab market, however. Another focus for the company is adding "meaningful assays" to its menu that "answer some of the big clinical questions," Costello said. The company recently introduced a new algorithm for the high-sensitive troponin T assay, and last year the FDA granted breakthrough device designation to its Elecsys cerebrospinal fluid in vitro diagnostic immunoassays for Alzheimer's disease.
The assays, Elecsys beta-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF, are used to measure beta-amyloid and phospho-tau peptide concentrations, respectively, in the CSF of patients with cognitive impairment who are evaluated for Alzheimer's disease or other causes of dementia. The company also offers a third CSF immunoassay, the Elecsys Total-Tau CSF. All three assays are CE-marked and can be used alone or in combination.
Costello emphasized that integrating these instruments and assays is a priority for Roche. "Our goal is to get to the one Cobas platform, to have a family of systems that are integrated, and really minimize the impact on our customers and maximize the time that they have to do other things."