Diagnostics & Imaging Week Contributing Writers

Another flight of the imagination is now in the intensive care unit (ICU). For the first time, not only noninvasive, but continuous accurate measurement of glucose has been demonstrated in an acute-care setting. Results of the study using the noninvasive glucose monitoring system developed by OrSense (Nes Ziona, Israel) were presented last week at the 26th International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels by principal investigator Pierre Singer.

"The ability to maintain normal levels of glucose in acute-care patients is currently one of the most important goals of intensive care units," said Singer, director of the general intensive care unit of Rabin Medical Center (Petah-Tikva, Israel).

"Recent studies show that preventing hyperglycemia with insulin substantially improves outcome of critical illness and reduces mortality in critical care patients," he said. "And that maintenance of normal glucose levels can shorten ICU stay, significantly reducing healthcare expense and improving quality of life for patients. Based on our study, the OrSense noninvasive glucose monitoring system could be used for continuous, accurate, safe and easy-to-use glucose evaluation in intensive care units."

The researchers took double-blind measurements from the OrSense device and compared them to measurements obtained by conventional invasive methods, finding similar equivalents.

The study demonstrated that the OrSense sensor device is both sensitive and specific, showing median relative absolute difference of 11.5% in glucose levels of 64-247 mg/dl, showing unprecedented accuracy measures of glucose levels in an acute care setting.

"Currently, monitoring methods can not fulfill the need for continuous glucose monitoring needed to safely implement tight glucose control-based protocols," OrSense CEO Lior Ma'ayan told Diagnostics & Imaging Week.

"The results of this study are indicative of OrSense's capabilities in producing breakthrough noninvasive glucose monitoring technology," he said. "We are continuing in our commitment to deliver the same level of accurate measurement for home glucose testing as in hospital settings," he added, showing D&IW the mock-up of the portable finger monitor that he said had already been shown to work in several trial cases.

The ICU study is one arm of three trials that were carried out on a total of 30 patients in three different hospitals in Israel. The results being presented come from a study conducted on six patients, three women and three men, between the ages of 44 and 88, while in the Rabin Medical Center ICU.

In the study, the OrSense sensor produced continuous noninvasive measurements for up to 24 hours. These running results were compared to measurements obtained by conventional invasive methods taken throughout the day. The range of the glucose levels measured in the study was 64-247 mg/dl. The resulting Median Relative Absolute Difference was 11.5%, and the Median Absolute Difference was 18 mg/dl.

The OrSense device is based on its Occlusion Spectroscopy technology. The company also has developed and is marketing a noninvasive monitoring product for other critical blood parameters, including hemoglobin and hematocrit in Europe.

Ma'ayan told D&IW that OrSense has an intellectual property portfolio consisting of 18 granted patents, with more than 25 additional applications in process.

He noted that serial entrepreneur Shimon Eckhouse is chairman of the board of the company, a vote of confidence for the technology, which he said also had been vetted by another board member, Karen Drexler, founder, president and CEO of Amira Medical (Scotts Valley, California), a company that was acquired by Roche Diagnostics (Indianapolis) in 2001.

Investors in OrSense include Israel Health Care Ventures and STAR Ventures.

UK BioBank enrolls first volunteers

UK BioBank, the world's largest study of genes and disease, has 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 plans to recruit 500,000 people, ages 40 to 69. The initial phase goal 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 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 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, BioBank chairman, said: "Following them will allow researchers to work out why some develop a particular disorder, while others do not" and help to develop new preventive and therapeutic possibilities.

The project involves 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. Tunning 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 but is now a supporter.

"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."

China Medical in ADS offering

China Medical Technologies (Beijing), a company that manufactures high intensity focused ultrasound (HIFU) products and in vitro diagnostic systems, reported a secondary offering of 5 million American depositary shares (ADSs), each representing 10 ordinary shares, at a price to the public of $25.50 per ADS.

Golden Meditech, General Electric International operations company and Chengxuan International are selling 2.2 million ADSs, 1.8 million ADSs and 1 million ADSs, respectively. The company will not receive any proceeds from the sale of ADSs by these selling shareholders.

In addition, Chengxuan International, Neon Liberty Capital Management and Golden Meditech have granted to the underwriters an option to purchase up to another 750,000 ADSs from them within 30 days from the date of the prospectus.

China Medical manufactures products using HIFU for the treatment of solid cancers and benign tumors. It says it believes it is a leader in the development of HIFU tumor therapy devices in China. In addition, it says it is the first China-based company to offer an advanced in vitro diagnostics system using enhanced chemiluminescence technology to detect various diseases and disorders through laboratory evaluation and analysis of blood, urine or other body fluids.