A Medical Device Daily

GE Healthcare (Waukesha, Wisconsin) said it has developed the largest bone mineral density reference database in the world in order to measure osteoporosis in the Chinese population. The company said the Chinese reference database provides improved diagnostic confidence for physicians in the prevention and treatment of osteoporosis, a disease characterized by low bone mass and increased risk of fracture.

The new reference database was presented last month at the International Society for Clinical Densitometry's (West Hartford, Connecticut) annual meeting in New Orleans.

"There are likely more people with osteoporosis in China than the entire population of the U.S.," said Jennie Hanson, president of GE Lunar (also Waukesha), a division of GE Healthcare. "GE's new BMD China reference database is a critical and important step in the world's fight against osteoporosis."

In a landmark study conducted with the Chinese Medical Association, bone density of the spine and hip was measured on GE Lunar densitometers in 11,400 men and women of differing age and weight in six geographically dispersed centers in China. Those locally derived reference values now will serve as a reference population for interpreting the bone density of the Chinese population, the largest in the world at more than 1.3 billion.

"We are proud to offer the Chinese population such a critical breakthrough in the diagnosis of this debilitating disease," said Hanson.

According to the World Health Organization (Geneva, Switzerland), the worldwide number of hip fractures associated with osteoporosis could rise from 1.7 million in 1990 to 6.3 million by 2050, with the most dramatic rise expected in Asia as this population both grows and ages. It is projected that about half of all osteoporosis-related hip fractures will occur in Asia by the year 2050, according to the International Osteoporosis Foundation (Lyon, France).

Realignment, growth for PPD in Asia

PPD (Wilmington, North Carolina) has reported an expansion of its presence and geographic realignment of its management team in Asia to optimize access for clients to treatment naive populations in the region and effectively navigate country-specific regulatory processes. PPD is a provider of discovery and development services and products for medical device, pharmaceutical and biotechnology companies.

In conjunction with the realignment, Edmund Leong, PhD, has been named director of strategic development for Asia. In addition to directing clinical operations in Southeast Asia, he will play what the company called "a significant role" in business development, interfacing with key customers and identifying new expansion opportunities for PPD in Asia. Leong joins PPD from GlaxoSmithKline (London), where he most recently served as manager of clinical development/operations within international clinical development and medical affairs for the Asia-Pacific region.

PPD's current offices in Southeast Asia are located in Singapore and Thailand.

K.C. Lau, PhD, director of clinical operations, will direct the company's operations in Northeast Asia, including PPD's newest location in Seoul, South Korea. The new office provides patient recruitment and clinical monitoring for Phase II to Phase IV studies in key therapeutic areas.

Other established PPD locations in the Northeast region include China, Hong Kong and Taiwan.

Samir Sadekar, manager of clinical operations, will continue to serve as the key contact for PPD operations in India. The company's Mumbai office, headed by Sadekar, opened in January of last in response to the heightened demand for increased CRO services in that country.

"We have assembled a management team with a thorough understanding of the nuances of varying regulatory processes and systems within respective Asian nations," said Fred Eshelman, PPD's chief executive officer. "This strategy enables us to conduct efficient global clinical studies for our clients in these emerging markets."

Earlier this year, PPD reported a strategic alliance to provide clinical operations and consulting services in Japan with CMIC (Tokyo), a contract research organization offering clinical research services and outsourcing of clinical research professionals in Asia. CMIC has more than 1,300 employees.

MSI in more TB testing programs

Medical Services International (MSI; Edmonton, Alberta) said it has been asked to participate in two additional testing programs with its VScan TB test kits. The test programs will take place in Eastern Africa and the Caribbean. The company said it is "very comfortable" that the accuracy of its VScan TB test kit will help in making the tuberculosis testing programs viable.

The company said: "As the accuracy of the VScan TB test kit becomes known through participation in these and other programs and [we] receive regulatory approval for the VScan TB in China, it is reasonable to expect that the demand for the TB test kit will be substantial."

MSI's VScan rapid test kit is a single-use, disposable, accurate, cost effective test for the screening of HIV 1 & 2, hepatitis B & C, tuberculosis, Dengue fever, West Nile virus, syphilis and prostate cancer.