Dako AS, has always been known for its technical acumen and has a strong following in niche laboratory segments, such as immunohistochemistry and in-situ hybridization. But as competition increases, regulations get tighter for research reagents, and customers demand integrated systems, Dako has had to change. It is becoming more focused on clinical products, necessitating major shifts in regulatory and sales and marketing functions, with an aim on achieving global coordination. HercepTest, its first clinical product, is a success, and it hopes to capitalize on a growing interest in pharmacodiagnostics. But it faces tough competition in the systems business from Ventana Medical Systems, a one-time small competitor that now dominates the IHC systems market. Dako is also gambling on a move into flow cytometry.

Anatomic pathology is consolidating rapidly due to changes in reimbursement and the looming presence of managed care. The pioneering players, AmeriPath and Dianon, are taking radically different approaches to gaining market share.

Diagnostics; Cytology. CytoLogix automates specialty staining for slide-based cellular analysis.

Few diagnostics start-ups are {bona fide} business successes, and that has put a damper on venture capital interest in the field. But this hasn't stopped start-ups trying to meet needs in cancer diagnostics, sample preparation and point-of-care.