Medical Device Daily Contributing Writer and Staff Reports

UK BioBank, the world's largest study of genes and disease, has formally gotten off the ground with enrollment of the first volunteers at an assessment center near Manchester to give blood and urine samples and agree to have their future health monitored.

The 61 million ($105.6 million) project eventually will recruit 500,000 people aged 40 to 69. The objective of the initial phase is to test all the procedures involved in recruiting volunteers, ensuring full consent, and taking and processing samples.

When the BioBank project was proposed in 2000, it was pitched as a discovery engine for pinpointing genes associated with chronic disease. But the study design was criticized by both politicians and by scientists, including Alec Jeffreys, inventor of DNA fingerprinting, and John Sulston, who led the UK's contribution to the Human Genome Project.

As a result, the emphasis has shifted to portray BioBank as one of the most powerful epidemiological studies ever undertaken.

The recently appointed principal investigator, Rory Collins, a professor of medicine and epidemiology at Oxford University (Oxford, UK), invoked the vision of studies that detected the link between smoking and lung cancer and cholesterol levels and cardiovascular disease.

“By being so large and so detailed, UK BioBank will be able to study many different risk factors together, each of which may have only modest effects on the likelihood of getting some particular disease,“ he said.

Taking part in the study has been likened to making a blood donation (for which donors are not paid in the UK). Noting that the 40- to 69-year-old volunteers are at risk of developing a wide range of disabling and life-threatening conditions over the next few decades, Alan Langlands, chairman of BioBank, said: “Following them will allow researchers to work out why some develop a particular disorder, while others do not. This should help enormously in the development of new ways to prevent and treat disease.“

The project is a massive undertaking, involving purpose-designed automated systems for blood sample preparation and storage, retrieval and tracking of around 10 million samples. These must be kept for several decades. When BioBank is running nationwide, it will need to take samples from 1,000 people per day.

One of the most vocal critics, Ian Gibson, a member of Parliament, acknowledged he had concerns about BioBank previously.

“As the project has evolved, I've had more opportunities to discuss its aims, design and future plans,“ he said. “Now, I am very confident that it will succeed and be an extraordinarily valuable resource for public health in the UK.“

Similarly, Alec Jeffreys said, “This is an important initiative that is now developing focus and which promises to provide an invaluable resource for investigating the causes of common diseases that will last for decades into the future.“

Georgia Tech plans Irish enterprise

The Georgia Tech Research Institute (GTRI), the applied research arm of the Georgia Institute of Technology (Atlanta), said earlier this month that it would establish a research enterprise in Athlone, Ireland, to focus on industry research and development needs.

GTRI Ireland will be GTRI's first applied research facility outside the U.S. Over the next five years, the Irish operation plans to build up a portfolio of research programs and collaborations with industry valued at more than $24 million, and at full operation, it will employ 50 researchers.

The new institute will focus on four technology areas that mirror Ireland's research strengths - biomedicine, digital media, energy and radio frequency identification (RFID). The biomedical research will focus primarily on medical devices for preventive and predictive medicine and manufacturing of medical devices.

GTRI Deputy Director Dr. David Parekh, who has been working with IDA Ireland for the past two years to bring this initiative to fruition, will have primary responsibility for developing GTRI Ireland strategy, establishing corporate alliances and selecting personnel to lead the endeavor.

GTRI conducts nearly $140 million in research and development each year for industry, government and academic institutions across the world. It will receive support from IDA Ireland , the agency responsible for industrial development and overseas investment in that country.

“Ireland is increasingly known as a world leader in innovation and for embracing technology. As Georgia Tech expands its global horizons, we seek partners who share our values and goals,“ said Georgia Tech President Wayne Clough. “Thus, we are especially pleased to celebrate the formation of this forward-looking collaboration with Ireland and our Georgia Tech Research Institute. We are grateful to the government and civic leaders of Ireland who worked on this exciting initiative with us.“

GTRI said the institute will work closely with Irish companies and universities, the Georgia Tech research community and U.S. companies to provide companies on both sides of the Atlantic with “industry-focused research and development that bridge the gap between academic discovery and commercial success.“

The research with RFID will center on authentication and identification technologies from acoustics to optics for the commercial sector. Because Ireland has a thriving pharmaceutical industry, some of the institute's research will target pill-tracking accuracy, ensuring authenticity and dosage.

CombiMatrix gets European patent

Acacia Research (Newport Beach, California) said its CombiMatrix (Mukilteo, Washington) group has been granted a key patent by the European Patent Office, EP1185363B1, titled “Self-Assembling Arrays.“

The patent was registered in Germany, France, Spain, Great Britain and Italy, and the company said the opposition period has passed. A corresponding U.S. patent is pending in the U.S. Patent and Trademark Office and is moving through the process.

The European patent claims both self-assembled arrays and a method for making self-assembled arrays on electrode arrays with self-assembled antibodies. Combi-Matrix said this microarray configuration is especially useful for arraying proteins, specifically antibodies.

The technology enables products such as multiplexed immunoassays, monitoring of biowarfare and terrorist agents, and general protein analysis tools.

“[Our] intellectual property strategy is designed to provide freedom to operate for CombiMatrix products as well as to establish strong barriers to protect the unique aspects and commercial advantages of our electrochemical synthesis and detection technologies,“ said Dr. Jeff Oster, senior vice president, legal at CombiMatrix.