Abbott has received a CE mark for its Alinity m molecular diagnostic testing machine, setting it up to sell the product across Europe, the company said Tuesday.
The device is designed to increase efficiency at laboratories that perform infectious disease testing, cutting the time it takes to provide physicians with diagnostic results. The initial test menu includes assays for HIV, hepatitis B and C, human papillomavirus and a range of other sexually-transmitted infections.
Abbott's introduction of Alinity m furthers its fast-growing franchise in a year in which it aims to pick up other key regulatory clearances.
The Alinity series of laboratory devices was a bright spot for Abbott last year. Rising demand for the first products in the range, such as Abbott's integrated clinical chemistry and immunoassay system, drove 8% sales growth at the core laboratory business.
Much of the sales growth to date has come from Europe, and while Abbott expects to pick up regulatory approvals for the critical mass of its test menu in the U.S., the company also sees opportunities to maintain the momentum it has built in CE mark countries.
Alinity m could support those efforts by adding molecular testing capabilities to the product line's range. The device is designed to perform tasks currently handled by four to six instruments.
"Alinity m will significantly improve the way we operate laboratories by letting staff run any sample at any time, without the need to group samples, allowing us to focus on giving physicians the information they need to make accurate, timely clinical decisions," Martin Obermeier, CEO of Medical Center for Infectious Diseases in Berlin, commented in Abbott's statement Tuesday.
Laboratories in the U.S. will have to wait a while longer to access the device, where Alinity m is still in development. That fits the pattern of the rollout of the broader Alinity range, key parts of which are due to arrive in the U.S. later this year.