A Medical Device Daily

Quintiles Transnational (Research Triangle Park, North Carolina) said its Quintiles Laboratories Asia (Singapore) unit has amended its existing agreement with Peking Union Medical College Hospital (PUMCH; Beijing) to enhance central laboratory services in China.

Under the agreement, Quintiles central laboratory (QLAB) facilities in China will have dedicated rooms for specimen management and analytical testing using Quintiles’ instruments and processes that follow QLAB global operating procedures and quality standards.

Quintiles said it already operates “the largest and most comprehensive” central lab testing facility in Asia at its Singapore base and has been providing central lab services in China under the initial agreement with PUMCH since October 2003.

Anand Tharmaratnam, MD, CEO of Quintiles Southeast Asia and QLAB Asia, said, “The new agreement represents true growth and quality standardization of our Asia central lab service. It . . . very nicely complements our clinical business, which is the largest pharmaceutical development group in Asia.”

Alan Ong, vice president and general manager, QLAB Asia, said of the enhanced services: “QLAB Asia performed nearly a million tests in 2004, of which 400,000 tests were for China trials. Our new enhanced services will now allow our customers to participate in the growth of clinical trials in Asia, freed from the problems and difficulties of exporting blood samples out of China.”

Quintiles said that QLAB in China would apply for accreditation from the College of American Pathologists (CAP; Northfield, Illinois) by early 2006. QLAB facilities in Singapore; Atlanta; Edinburgh, Scotland; and Pretoria, South Africa, all are CAP-certified.

Quintiles Asia has clinical development offices across seven countries in Southeast Asia, among Quintiles Transnational’s offices in 50 countries. Since 1995, the Quintiles clinical team in Southeast Asia reports completing more than 150 Phase II and III studies from 1,000 sites and recruited more than 35,000 patients into international clinical trials. Its central lab operations in Singapore has serviced more than 200 studies, with samples shipped in from 15 Asia Pacific countries.

ChondroGene in pact with Penang hospitals

ChondroGene Limited (Toronto) reported entering into clinical collaborations with Lam Wah EE Hospital and Island Hospital (both Penang, Malaysia).

The hospitals will begin collecting blood samples from consenting patients in disease areas that coincide with ChondroGene’s primary areas of interest – cancer, cardiovascular disease, central nervous system disorders and arthritis. The information will provide data for identifying blood-based biomarkers for specific diseases. The data will also be added to ChondroGene’s database of gene expression profiles which, it said, contains profiles from several thousand people with a wide range of disease conditions, as well as from normal patients.

Dr. C.C. Liew, chief scientific officer of ChondroGene, said, “Initially, these hospitals will be a key source of genetically diverse clinical samples in a variety of disease areas. Eventually, they will offer their patients ChondroGene’s molecular diagnostic tests and services based on the Sentinel Principle.”

Norwood EyeCare, B&L in distribution pact

Norwood Abbey (Melbourne, Australia) reported that its subsidiary, Norwood EyeCare (Duluth, Georgia) and Bausch & Lomb (Australia) (New South Wales) have signed an agreement for B&L to distribute Norwood’s Epi-LASIK system, with EpiEdge disposable separator, in Australia and New Zealand. Financial terms of the arrangement were not disclosed.

B&L (Australia) claims leadership in the refractive market in both countries.

Craig Stamp, managing director of B&L (Australia & New Zealand) called Norwood’s Epi-LASIK system “a good fit for our existing portfolio of refractive products in Australia and New Zealand.”

Epi-LASIK, an advanced generation of laser vision correction (LVC) reduces the disadvantages of LVC, “particularly the need to cut the eye,” according to Norwood.

Epi-LASIK received approval by the Australian Therapeutic Goods Administration this past April.

Richard Walmsley, CEO of the Norwood Devices group, said, “The company is now at the forefront of LVC in Australia and across the world, and it is fitting that we have one of the leading ophthalmology companies worldwide marketing our technology in the region. . . . In Australia alone, there are close to 30 laser refractive centers, with an expected 30,000 patient procedures being undertaken in 2005.”

Norwood Abbey has exclusively licensed the worldwide rights from the inventor of the Epi-LASIK technology, Professor Ioannis Pallikaris, MD, PhD, president of the University of Crete, Greece. Pallikaris is a consultant to Norwood Abbey as a foundation member of its clinical advisory board.

MD51 to supply 2nd Mobetron in Italy

Intraop Medical (Santa Clara, California) reported that MD51, the company’s partner in Italy, was awarded the contract to supply a Mobetron for the intraoperative radiation therapy (IORT) program at Azienda Ospedaliera Istituti Ospitalieri Di Verona, a consortium of three hospitals that includes the Medical School of the University of Verona.

The Mobetron will be located in the Ospedale Borgo Trento in an operating room dedicated to IORT treatments. The Mobetron at Ospedale Borgo Trento, scheduled for delivery next month, will be the second Mobetron in Italy and the sixth such system in Europe.

Providing IORT treatment for cancerous tumors, the Mobetron is mobile, because light-weight, and shelf-shielding.

Ernesto Lanzotti, president of MD51, said, “In Italy, IORT has already become an important component of cancer treatment. If they don’t already have it, most major hospitals have plans to acquire IORT treatment capability. For those that already have IORT capability, the larger centers might need more than one system as IORT is integrated into the treatment of more common cancers such as breast, lung and prostate. We believe that the Mobetron can best serve this growing demand.”

Intraop was formed in April 1993 to manufacture the Mobetron, a mobile electron beam system designed for IORT treatment of cancer, coronary/vascular restenosis and other medical applications.