Dive Brief:
- FDA has approved Abbott's latest blood and plasma screening system, the company announced Thursday morning.
- The new device, Alinity s, can run up to 600 tests per hour, improves tracking ability for donation testing and processing and increases the time technicians can be away from the machine, Abbott said in a press release.
- 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, with much of the sales growth coming from Europe, where the Alinity M device received a CE mark in March.
Dive Insight:
Abbott has been awaiting U.S. regulatory approvals for the critical mass of its test menu in the U.S., so the FDA approval is welcome news for the company.
On an earnings call in April, CEO Miles White named Alinity a key growth driver alongside its mitral repair device MitraClip and continuous glucose monitor FreeStyle Libre, noting the diagnostics systems have achieved above-market growth in the U.S.
In addition to Alinity s, the product line includes a variety of diagnostics instruments systems, including a hematology system and a highly automated molecular diagnostic system.
Alinity s is designed to screen blood and plasma more efficiently within a smaller space than commercially available competitive systems.
Abbott said Alinity s can make the blood and plasma screening process more efficient, in part by improving what the company called "walk-away" time, or the hands off time lab professionals have away from the machine while it processes samples. It achieves that, in part, by enabling users to load and unload samples without stopping the system, Abbott said in a press release.
