A Diagnostics & Imaging Week

Just as Given Imaging (Yokneam, Israel) was launching its improved PillCam SB Capsule as well as the first official publication of guidelines and algorithms for both PillCam SB and PillCam ESO in several disease states, the company reported last week that its corporate vice president of regulatory and medical affairs, Shoshana Friedman, was honored with what is considered the highest honor bestowed by the Regulatory Affairs Professionals Society (RAPS) – its Richard E. Greco Award, which recognizes outstanding leaders making significant contributions to the profession.

Given Imaging, Micron Technology (Boise, Idaho) and Zarlink Semiconductor (Ottawa, Ontario) joined together earlier this month to announce that they are finalizing development of a third-generation PillCam SB for the small bowel. The new advanced capsule endoscope is expected to be commercially available next year. It will significantly enhance viewing capacity and imaging quality with new optical and image sensor technology at a frame rate doubled from two to four frames (images) per second, while increasing the capsule’s operational time from eight to nine hours.

Micron’s complementary metal-oxide semiconductor (CMOS) image sensors and Zarlink’s ultra-low-power RF (radio frequency) transmitter chips are being incorporated in Given’s PillCam SB video capsule and PillCamESO for imaging the esophagus as well as in the future PillCam COLON for the large intestine, now in clinical trials.

The Israeli company said that it continues development of a complete line of PillCam video capsules for detecting disorders of the gastrointestinal tract based on its technology platform, the Given Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient.

The publication of the Given Imaging Guidelines in the October issue of Endoscopy, the journal of the European Society of Gastrointestinal Endoscopy (ESGE; Munich, Germany), was made in recognition of the need to formalize practice guidelines for using capsule endoscopy. Consensus reports also were published from this year’s International Conference on Capsule Endoscopy.

Given Imaging noted that more than 400 gastroenterologists from 38 countries attended the meeting, many of whom had contributed to the resulting documents by their feedback in usage consensus reports.

Gavriel Meron, president and CEO of Given Imaging, reported Friedman’s receipt of RAPS’ highest honor. “We congratulate Shosh on receiving this prestigious award and are proud that her peers have honored her achievements. She has been instrumental in helping Given Imaging to build collaborative and productive relationships with regulatory agencies worldwide and we know this award is well deserved,” he said.

Since joining Given in 2002, Friedman has led the activities for marketing authorization worldwide (FDA clearance, CE mark, Canadian license and Australian listing).

IBM, Matria collaborate on health management

IBM (Armonk, New York) and Matria Healthcare (Marietta, Georgia) have entered into a collaboration to offer health management services to Japanese insurance companies. The companies said the move comes at a time when Japan is wrestling with increasing healthcare costs brought on by its rising population of seniors, the fastest-growing segment of the country’s population.

“Through our agreement with IBM, Matria will become one of the first U.S. disease management companies to offer these services to Japanese companies,” said Parker Petit, Matria chairman and CEO. “In recent years, we’ve seen U.S. employers embrace health enhancement and disease management services as a solution to their rising healthcare burdens. We are very encouraged to see other healthcare systems and international employers recognize the benefits and improved outcomes that disease management can bring to their covered populations.”

Matria’s Total Health Enhancement Solution consists of a broad array of programs that address the continuum of care ranging from wellness and prevention to disease management for chronic and high-cost diseases.

Ellen Yoon, global health insurance manager for IBM, said, “Healthcare expenditures in Japan are increasing due to the aging population and the rise of lifestyle-related diseases such as heart disease and diabetes. [Our] collaboration with Matria will bring solutions which can help address the healthcare impact of these demographic changes.”

Noting that the average tenure of a Japanese worker with his or her employer is more than 12 years, “much higher than the average among U.S. workers,” she said that with the “prevalence of long-tenured and ‘lifetime’ employment in Japan, employers and employees stand to benefit from health enhancement programs.”

Matria manages major chronic diseases and episodic conditions including diabetes, congestive heart failure, coronary artery disease, asthma, chronic obstructive pulmonary disease, high-risk obstetrics, cancer, chronic pain, depression, end-stage renal disease and obesity. It also delivers programs that address wellness, healthy living, productivity improvement, and patient advocacy; and provides case management of acute and catastrophic conditions.

The company has more than 40 offices in the U.S. and internationally.

Agendia adds new investor

Agendia BV (Amsterdam, the Netherlands) said it has closed a second financing round with the Van Herk Group (Rotterdam, the Netherlands). Van Herk Group joins Gilde, AXA and GLSV as investors in the company. CEO Bernhard Sixt, PhD, said, “Van Herk Group is a financially solid investor that shares [our] vision of the potential of gene expression profiling to improve treatment decisions in cancer.”

Agendia said it is the first company worldwide to commercialize microarray-based diagnostics. MammaPrint, its breast cancer test, predicts the aggressiveness of breast cancer tumors based on the activity of 70 key genes.

In March, the company launched its second product based on microarray, CupPrint, to identify the origin of a tumor of classified as cancer of unknown primary origin.

Sixt said, “I strongly believe that personalized medicine is going to change the way patients are treated in the near future, especially in the area of oncology. With access to the world’s largest frozen tumor bank and to outstanding cancer research, Agendia is very well positioned to lead this development.”

The funds raised will be used to accelerate development of microarray-based, late-stage products into diagnostic tests for other cancer types and to market MammaPrint and CupPrint. Agendia said it expects to launch two new products early next year.

The company recently received ISO 17025 certification for its Amsterdam laboratory facilities, which Sixt said “puts the company in an excellent position to make MammaPrint available for patients globally.”

Agendia maintains close ties with the Netherlands Cancer Institute, which it said ensures access to the latest developments in cancer research. Apart from the development of new cancer diagnostics, the company also offers its expertise in finding new predictive gene expression profiles to companies focusing on new drug development in the area of oncology.