Originally Published IVD Technology
March 2004
INDUSTRY NEWS
NotableEver since FDA found Abbott Laboratories’ (Abbott Park, IL) production facility in Lake County, IL, to be in substantial conformity with the agency’s quality system regulation, the company has made progress on reclaiming its lost share of the IVD market.
In January, Abbott finalized plans to purchase Therasense (Alameda, CA) for $1.2 billion. Abbott initially broached the glucose monitoring market with its purchase of Medisense in 1996. Through the latest acquisition, Abbott seems to have positioned itself as a major player in the glucose monitoring market.
Medisense “excels in the relationships it has with hospitals and long-term care providers,” according to Rhonda Luniac, a spokesperson for Abbott. Therasense offers a smaller sample size, smaller monitor, and faster testing time. Therasense also has a continuous blood glucose monitor in development, which may offer important advantages for insulin-dependent diabetics who need to test frequently.
In February, Abbott acquired control of I-Stat Corp. (East Windsor, NJ), which develops and manufactures point-of-care blood-based testing for critical-care diagnostics. Abbott has also teamed up with
Atria Genetics (San Francisco) to distribute a line of molecular tests for defining human leukocyte antigens (HLAs), which are used to identify potential donors in the matching process for bone marrow transplantation.
According to Luniac, Abbott plans to bring 60 new assays to the U.S. market this year. In February, Abbott and
Axis-Shield (Dundee, Scotland) received FDA clearance for their B-type natriuretic peptide test. Later that month, Abbott received FDA approval for 11 new assays for hepatitis, prostate-specific antigen, and alpha-fetoprotein.
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