Ostex International Inc. said Tuesday that it is supplying bone-loss test reagent to Nichols Institute Reference Laboratory, oneof the largest providers of esoteric clinical reference laboratoryservices and kits in North America.

Privately held Ostex of Seattle, formed in 1989 in acollaboration with the University of Washington, offers animmunoassay to detect bone loss. The technology is based uponthe discovery that N-telopeptide crosslinks of bone collagen areexcreted in urine.

This discovery is based upon the work of David Dyre, aprofessor of orthopedics at the University of Washington. Theuniversity receives licensing fees, research grants and companystock in exchange for an exclusive license to commercialize thebone loss and related technologies. Ostex licensed an originalU.S. patent covering assays for bone collagen fragments, holds asecond patent on assays for collagen fragments from connectivetissue and has received notice of allowance for a third patentcovering different types of assays for detecting bone andconnective tissue loss.

Ostex is also working on genetically engineering a drug forosteoporosis to stimulate bone formation, R.C. Tarbox III, thecompany's vice president told BioWorld.

Estrogen is the approved osteoporosis therapy in the U.S., butposes potential problems for women at risk of breast cancer.

"There is no specific biochemical marker for bone loss in theUnited States," Tarbox added. Metra Biosystems Inc. of PaloAlto, Calif., and Orion of Finland market tests in Europe thatdiffer by measuring total collagen loss, then calculate thepercent attributed to bone, he said.

The technology that allows Ostex to identify fragments ofcollagen-based tissue lost from bone, cartilage and lung is beingdeveloped into other tests, Tarbox said, such as one to trackosteoarthritis and another to measure lung breakdown inemphysema.

Ostex is currently conducting clinical trials to measure safetyand efficacy in the U.S. Clinical trials are also under way inJapan, where Ostex has entered into a license agreement withMochida Pharmaceutical Co. Ltd. for commercialization of theproduct.

Increased bone loss occurs in bone cancer, kidney failure andPaget's disease, as well as osteoporosis.

Tarbox said about 5 percent to 10 percent of the womenentering menopause worldwide may eventually be monitoredfor bone loss associated with decreased production of estrogenby the ovaries. About 30 percent will then receive long-termosteoporosis therapy, he said. The overall world market isprojected to be from $50 to $150 million.

-- Nancy Garcia Associate Editor

(c) 1997 American Health Consultants. All rights reserved.

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