Metra Biosystems; Focus On Bone Disorders

With the launch of its Alkphase-B bone formation assay, bone disease specialist Metra Biosystems now has a complete panel of laboratory-based tests for the diagnosis and risk assessment of potentially debilitating metabolic bone disorders, including all three of the tests recommended by the US Food and Drug Administration in its 1994 draft guidelines to pharmaceutical companies regarding the development of drugs to prevent bone loss.

Alkphase-B provides the first non-isotopic measure of the amount of bone-specific alkaline phosphatase (produced by osteoblasts). Elevated levels of this enzyme denote an increase in bone formation activity, which in turn is an indication of increased bone turnover. Metra submitted a 510(k) to the FDA for Alkphase-B in January.

The test complements Metra's Pyrilinks and Pyrilinks-D bone resorption assays, which measure the levels of pyridinium crosslinks, byproducts that are released into the urine when bone is degraded by osteoclasts. These assays are already being used clinically in many countries throughout the world and for research in the USA, said Metra's director of European sales, John Coombes, in an interview with the Marketletter.