FDA clears Abbott IVD system for screening blood, plasma donations

Abbott's screening system has the capacity to perform up to 600 tests per hour, and the ability to load samples and restock supplies without stopping. (Abbott)

Abbott has received FDA approval for a new addition to its Alinity line of laboratory diagnostic hardware designed to screen blood and plasma donations for potential contaminants.

The company described the Alinity “s” system as designed for a smaller space, with additional automation options that can allow users to leave the machine running for at least three hours while focusing on other duties.

It also includes the capacity to perform up to 600 tests per hour along with the ability to load samples and restock supplies without stopping the system.


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"These elements are important to blood and plasma services of all sizes, supporting Abbott's overall mission to help people live longer, healthier lives by keeping the global blood and plasma supply safe," Louis Morrone, Abbott’s vice president of transfusion medicine, said in a statement.

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The Alinity "s" system received a CE mark in January 2017. Abbott’s wider Alinity line includes an integrated clinical chemistry and immunoassay system, as well as hematology and molecular diagnostic systems that are under development for U.S. use.

Together, the lab hardware—along with the medtech giant’s MitraClip heart valve repair system and Libre continuous glucose monitor—were the primary drivers of growth in Abbott’s quarterly earnings earlier this year. The three offerings accounted for 62% of the company’s growth while making up 26% of its revenue, according to reports. The latest FDA approval, granting market entry as an in vitro diagnostic for blood and plasma donations, looks to add to that bottom line.

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“GlobalData estimates that upwards of 151 million whole blood and source plasma donations were collected in 2018, with the majority being in the North American and Asia Pacific regions,” said GlobalData medical devices analyst Alison Casey, commenting on the Alinity "s" system. “These donations are screened for a number of different infectious diseases, meaning that they drive high volumes of sales for IVD reagents each year.”

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