NEW YORK – With the launch of its new Cobas Pure Integrated Solutions platform, Roche is aiming to address the needs of low- to mid-volume laboratories, namely those found in integrated health system networks.
The system, which combines clinical chemistry, immunochemistry, and ion-selective electrode testing into one instrument, received 510(k) clearance from the US Food and Drug Administration last month and will be launched in the US in late November. The platform launched in countries accepting the CE mark last year after obtaining the certification in March 2021.
The Cobas Pure is a "tandem technology" to the firm's higher throughput Cobas Pro Integrated Solutions analyzer, which received marketing clearance from the FDA in 2019, said Brad Moore, Roche's senior VP of core lab and point-of-care business in the US. The Pure is intended for sites that are "not the largest sites that we have … [but] they have reasonable volume." It can run up to 870 tests per hour, although Moore noted that the company wouldn't expect laboratories to use all of that capacity routinely. The Cobas Pro, meantime, can run up to 4,400 tests per hour, depending on its configuration.
The Pure will also have the same test menu as the Pro, with the Pure versions of the tests available on the Pro expected to roll out over the course of the next year. In addition to the 510(k) approval for the platform, the FDA also approved the first round of assays: a glucose test, a sodium test, a methadone test, and a thyroid-stimulating hormone test. After those initial assays, there will be a "rapid cascade" of tests approved to fill out the menu, Moore said.
The Pro has more than 180 tests currently available, including tests for infectious disease, anemia, immunosuppressant drugs, and fertility and hormones. Moore said 93 percent of the tests have a turnaround time of 18 minutes or less, although a few take up to 27 minutes, while the Stat line of assays has a nine-minute turnaround time.
Roche has used a similar strategy before in its Cobas product line. The firm offers its Cobas 6800 and 8800 platforms, which are high-throughput molecular instruments, and recently rolled out its Cobas 5800 system — a lower-volume version with the same test menu.
While the majority of users in the US are expected to use the Cobas Pure instrument in its full combination with all modules, Moore said that there are other configurations of the instrument available, including as a standalone immunochemistry analyzer and a standalone clinical chemistry analyzer with ISE testing. He noted that the company hasn't fulfilled any US orders, although it does have Cobas Pure placements in Europe and Canada.
The goal in developing the instrument was to bring the "same benefits" of Cobas Pro to small and mid-volume laboratories, Moore said. The laboratories that Roche is targeting are largely smaller labs within broader healthcare networks, although the company also expects demand from lower-volume standalone laboratories, he said.
"As market consolidation within healthcare systems continues, you have larger and larger systems, and within those systems, you have every variety of size of lab," he said. Those sites could include regional hospitals, smaller rural hospitals, or specialty clinics that "require the full breadth of testing menu and would benefit from the latest technology" but don't have the volume needed to justify a higher-throughput platform.
By using the same test menu and technology for both Pure and Pro, the same reagents can be used across multiple laboratories in a health system, regardless of size, allowing these networks to "better manage their inventory across their range of sites," he said. That same test menu also ensures that the testing performance parameters and reference ranges are consistent across instruments so different labs can correlate their results.
"Health systems that want to have standardized protocols and as much commonality in their patient care as possible can now provide that consistency across all their different sites where their patients may visit," Moore noted.
The user interface is also the same across both instruments, allowing laboratory technicians to be trained on one platform and be able to use the other.
There are two general customer situations the company expects to target, at least in the US, Moore said. One is a health system looking to standardize its core lab chemistry testing and placing multiple instruments in multiple sites all at once. The other is a customer, maybe a small standalone laboratory, that is interested in specific test offerings and looking to augment its current portfolio. Moore said Roche expects the first type of customer to be more predominant, but the second may also be a source of demand for the platform.