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Alere received clearance for the Afinion HbA1c Dx and for the Alere i Strep A 2, a rapid molecular test for the qualitative detection of Streptococcus pyogenes.
At least one HIV self-test from a competitor could reach the global market this year. In addition, the company is in the midst of a strategic review.
The study found that central laboratory troponin and chemistry testing dropped by half, and POC testing improved care.
The newly independent firm will continue to invest in diagnostics by bringing its menu of PCR tests for infectious diseases to the US and other markets, among other objectives.
Sanquin provided input to the design of Abbott's next-generation Alinity s system and served as a clinical testing site during the development process.
The company unveiled forthcoming products for high-throughput molecular testing, diagnostic lab informatics, and microbiology automation.
The firm said that it expects to log $500 million in revenues from its Alere rapid diagnostics business in the second quarter.
Practice recommendations could serve as a guide for labs considering using the high-sensitivity assays as they become available, authors said.
The company will pay the US $33.2 million to settle allegations that it caused hospitals to submit false claims to federal healthcare programs.
The firm aims to have its test on the European clinical market by early next year, followed by a launch in the US.