Breakthrough Test for Bone Loss Stands Test of Time

More than 10 million adults in the United States have osteoporosis — weak, brittle bones vulnerable to fracture. Another 35 million have low bone density that can progress to osteoporosis. Health care costs for osteoporosis-related fractures total about $20 billion annually in the U.S., and are rising with our aging population. Most people have no symptoms of the disease and may receive no treatment to prevent the condition from worsening unless it is detected early.

Osteoporosis GraphicA product to detect increased bone loss is a UW commercialization success story and prime example of how basic scientific research can move from the laboratory into the marketplace to improve diagnostic methods and impact health care.

Innovation by a Star Research Scientist

The story begins more than 25 years ago in the laboratory of Dr. David Eyre, a biochemist and UW professor who holds the Ernest M. Burgess Endowed Chair for Orthopaedic Investigation in the Department of Orthopaedics. Eyre is an internationally recognized expert in the structure and metabolism of collagen, the main structural protein that forms the essential framework of bones and cartilage.

Bone building and degradation are continual body processes that work in balance to maintain normal bone mass and strength in healthy adults. In disease, or as part of the aging process, bone can lose more mass than is replaced, a condition that physicians diagnose by X-ray or bone scans.

In 1985 Eyre hit upon a new method to detect accelerated bone loss by measuring a specific protein fragment of bone collagen that he had been researching called NTx. This molecule is produced upon bone resorption, released into the bloodstream and eventually excreted in the urine. Eyre and his colleagues recognized its potential to more precisely and inexpensively monitor the physiological process of bone resorption, potentially as a diagnostic in the early stages of a disease process, which could lead to treatment to halt or slow its progression to osteoporosis.

Spinoff Company Develops Commercial Test

Eyre disclosed his innovation to the Washington Research Foundation (WRF), at that time the licensing agent for universities in the state. WRF handled the original patent filings and continues to own and license the technology. The initial plan was to grant licenses to biomedical companies.

“Some European companies wanted to license the technology for next to nothing, and other interests were copying the intellectual property, so I finally realized we needed to form our own company to get the product to market,” Eyre said.

In 1989, with WRF assistance, Eyre and local investment partners and biotech entrepreneurs established Seattle-based company, Ostex International, to develop a commercial test, named Osteomark® NTx, and guide the product through FDA approval. Ostex gradually expanded from a handful of laboratory staff to 60 people, and went public in 1995 with a $35-million IPO.

“Originally we thought our highly specific test might replace or augment the standard clinical methods physicians use to diagnose bone loss.” Eyre said. “But the health care industry wasn’t ready to abandon X-rays and bone scans, so clinicians instead used our biochemical test as a supplementary diagnostic tool to help determine the rate of bone loss and its possible causes.”

Ostex was generating about $5 million per year in sales but not growing fast enough for investors, so in 2003 the company was sold to Inverness Medical Innovations, a Massachusetts-based developer of women’s health products and diagnostic technologies.

Center for Commercialization Retains Key Tools for Ongoing UW Research

“The original research had generated about 35 patents, including valuable tools for making interesting monoclonal antibodies, and WRF had not licensed all of them to Ostex. These tools were not relevant for the commercialization of the NTx assay, but were very useful in our research, Eyre said.”

When Inverness requested all of the intellectual property rights, the UW Center for Commercialization (C4C) stepped into the negotiations and ensured that Eyre was able to retain the rights to the tools and materials that would continue to benefit his basic research on bone and collagen disorders.

“C4C’s assistance was invaluable, and my lab is still using these tools for new discovery,” Eyre said. “They may lead to breakthrough treatments for bone and joint disorders and perhaps eventually new spinoff companies.”

Osteomark NTx Still the “Gold Standard Test”

In recent decades Merck and other pharmaceutical companies have developed drugs to treat bone loss, products that now have large markets. The precision and reliability of Osteomark NTx made it an ideal assay to analyze the effectiveness of their drugs during product development.

“Over the last ten years pharmaceutical companies have probably been the biggest buyers of Osteomark. The commercialization process has been an example of a technology taking off on its own trajectory that is somewhat different than the original intent,” Eyre said. “Osteomark has stood the test of time. It’s is still the gold standard assay for bone resorption, and taking this discovery from basic laboratory research to market has been one of the highlights of my career.”

Inverness and Osteomark NTx are now under the umbrella of Alere, a Boston-based consumer and professional medical diagnostic products company. Along with use by pharmaceutical companies, the product remains one of the leading biochemical measures that physicians use to diagnose bone mass disorders.