Laboratory automation offered by large diagnostic companies has been slow to gain customer acceptance. One bright spot has been Dade Behring Inc.'s Dimension product line, which has found in recent years a loyal following. The Dimension RxL offers the first chemistry analyzer that has the option of also running a number of common heterogeneous immunoassay tests. It has been a huge success, giving Dade a 92% market share of the 32% of laboratories that have systems integrating clinical chemistry and immunoassays, helping labs save labor, time and money. Dimension is the product line most responsible for Dade's comeback from bankruptcy two years ago.

The diagnostics industry grew an estimated 7% from 2000 to 2001, to more than $20 million, with 8% projected for this year, according to Boston Biomedical Consultants. While in some industries, that figure might be considered lackluster, in diagnostics it is far better than the norm, especially considering that the growth was solid and broad, benefiting most top companies in many product categories.

FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.