Roche’s headquarters tower in Basel, Switzerland, in a November 2015 file photo. Photo: Fred Romero / Wikimedia Commons / CC BY 2.0. Resized.
Roche said Tuesday it received the CE Mark for a compact laboratory testing machine designed to let smaller hospitals and clinics perform more tests themselves instead of sending samples to a larger laboratory.
The cobas smart e immunoanalyzer takes up about 0.9 square meter of bench space and is designed for low-volume sites. Roche plans a menu of more than 100 tests covering areas including heart and metabolic conditions, cancer and infectious diseases, with the tests introduced in successive waves.
For a clinic or hospital administrator, the business question is whether bringing selected testing in-house can shorten the wait for results without creating an unmanageable staffing, space or maintenance burden. Roche is pitching the new platform at that gap between a small local laboratory and a high-volume central testing site.
Smaller machine, shared testing system
The analyzer uses the same reagent packs and Elecsys technology as Roche’s larger laboratory systems, the company said. Reagents are the materials used to run the tests. Sharing those materials and testing technology is intended to help health systems compare results from different locations.
Roche said the platform has 36 reagent positions and can provide up to two hours of walk-away time on a load of 36 samples. That is a description of how the machine is designed to operate, not a guarantee that a laboratory can run without staff or supervision.
The company said more than 90% of its immunoassays have reaction times of 18 minutes or less. Reaction time is only one part of the full wait for a patient’s result: collecting, transporting, preparing and reviewing a sample can add time. Tuesday’s announcement did not provide a measured reduction in total patient turnaround time at hospitals using the new machine.
Less infrastructure, but purchasing details still matter
Roche said the analyzer has an integrated water tank, works with standard power and includes dust-protection features. Those design choices are meant to make it easier to use in smaller or resource-constrained facilities that may not have the infrastructure of a central laboratory.
The company also said routine daily operator intervention takes about one minute, with hands-on maintenance reduced by up to two-thirds compared with earlier-generation platforms. Those are manufacturer performance claims; the announcement cites Roche user guides and data on file rather than an independent hospital cost study.
Roche did not disclose a purchase price or test-by-test running costs in the announcement. For a health system, the calculation would include the equipment, reagents, staffing and the volume of samples that would otherwise be sent elsewhere. A smaller footprint alone does not establish that in-house testing is cheaper for every site.
What Tuesday’s clearance does and does not mean
The regulatory milestone announced Tuesday is a CE Mark, not a U.S. Food and Drug Administration clearance. Roche did not announce U.S. FDA clearance for the platform in this release.
The full planned test menu is also not arriving at once. Roche said assays will be introduced in sequential waves, making the availability of a particular test one of the details a prospective buyer would need to confirm.
Roche is presenting the system at the International Federation of Clinical Chemistry and Laboratory Medicine conference in New Delhi, which runs October 25 through October 29. The launch extends the company’s laboratory portfolio toward sites with less space and lower sample volumes, while leaving the practical purchasing decision dependent on the tests and services each facility actually needs.
JBizNews Desk | Basel
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