Ostex International Inc. has lined up Johnson & Johnson ClinicalDiagnostics Inc., as well as Boehringer Mannheim Diagnostics, asco-exclusive marketers of its Osteomark immunoassay to measurebone loss.

Last month the FDA approved the product, which is a urinary testthat measures human bone resorption. Both Boehringer Mannheimand Johnson & Johnson intend to use Osteomark on their instrumentsystems. Mochida Pharmaceutical Co. Ltd., the first partner signed upby Ostex, has marketing rights in Japan.

Ostex, of Seattle., received up-front payments from its marketingpartners and also will manufacture Osteomark, selling it to Johnson &Johnson and Boehringer Mannheim, said John Brenneman, directorof finance and operations for Ostex. When the partners incorporatethe test into their systems, Ostex will sell the critical reagents forincorporation into the testing kit and get a royalty from end sales.

In osteoporosis, bone loss exceeds bone regeneration, resulting in adecrease in bone mass. The test measures collagen breakdownproducts excreted in the urine, which Brenneman said is a responsiveindicator of rate of bone loss. Specifically, the test measures cross-linked N-telopeptides of mature bone collagen.

The peptide is a prominent cross-linking site in the Type 1 collagenof bone, Brenneman said. The peptide fragment containing the site isthe antigen recognized by the Osteomark assay.

The test is designed to identify those who are losing bone rapidly sophysicians can prescribe appropriate therapies. And the informationcan be used to determine how a certain therapy is working. _ JimShrine

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