A Medical Device Daily

Dune Medical Devices (Caesarea, Israel) has reported what it termed “significant new clinical developments” surrounding its newly trade-named MarginProbe breast cancer assessment probe, currently in investigational use.

The MarginProbe consists of a sterile, hand-held probe and portable console. When the probe tip is applied to an excised lumpectomy segment, radio frequency signals are transmitted into the tissue and are reflected back to the console, where they are analyzed using a specialized algorithm to determine tissue status.

The company said results from a recent randomized clinical trial conducted at 11 medical centers in Israel “have underscored the safety and clinical benefit of the system in the intraoperative detection of tumors at the resection margins (positive margins) in specimens of patients undergoing breast-conserving surgery.”

The study compared the performance of 35 surgeons operating on patients with and without the MarginProbe. Dune Medical said use of the system “resulted in a significant reduction in repeat surgeries, which are typically performed in order to surgically correct positive margins found following a patient’s initial lumpectomy.”

The company said the effect of the MarginProbe is “especially pronounced in patients with non-palpable lesions.”

Preliminary results for more than 110 patients with non-palpable lesions showed a 60% reduction in repeat surgeries in the study arm that allowed use of the MarginProbe. Dune said these results reflect initial data from the first 200 patients recruited and analyzed in the study.

Final results from the entire 300-patient cohort are scheduled for presentation at the annual meeting of the American Society of Breast Surgeons (Columbia, Maryland) in New York in May.

“I believe that these data demonstrate the potential utility of the MarginProbe in reducing the patient anxiety and discomfort associated with repeat breast surgeries while reducing the unnecessary use of healthcare resources,” said Dr. Tanir Allweis of Hadassah Hebrew University Medical Center (Jerusalem), an investigator in the study.

Dr. Dan Hashimshony, founder and CEO of Dune Medical, said, “The new data is promising. It suggests that the MarginProbe facilitates equally safe yet more accurate surgeries and will enable completing the surgical management of breast cancer patients with fewer repeated surgeries.”

The company said the MarginProbe core technology, which relies on radio frequency spectroscopy for real-time tissue assessment during surgeries, also will provide a platform for additional surgical oncology applications.

Dune Medical also announced the opening of a New Jersey office to spearhead North American activities. It said it is poised to launch further clinical trials of the system in the U.S. in order to acquire data for an upcoming FDA submission.

Founded in 2002, the company privately held and venture-funded, backed by Apax Partners.

Quintiles expands, consolidates in China

Quintiles Transnational (Research Triangle Park, North Carolina) reported the expansion and consolidation of its Global Central Laboratories and Clinical Development Services (CDS) units in Beijing to accommodate the company’s growing business in China.

The consolidated Quintiles China facility, with more than 17,000 square feet of space, is located at Sun Dong Ann Plaza in Beijing, about one block from the previous lab site in the Peking Union Medical College Hospital. The new facility expands the lab space by 2,600 square feet.

The lab has 13 employees and the staff is expected to reach more than 60 over the next 12 months, Quintiles said.

“Quintiles’ business is growing at a significant rate, and our larger facility will allow us to efficiently accommodate both the growth and our expanding test menu, which have moved well beyond basic safety testing to include specialized chemistry, PCR testing and complex flow cytometry,” said Tom Wollman, senior vice president, global central laboratories.

Lai Lee Tan, head of clinical operations and general manager in China, said the consolidation of CDS and central lab operations in a single facility will improve coordination and efficiency for Quintiles’ customers. “The globalization of clinical research is continuing to increase, and China is just beginning to see the rapid growth we have experienced in India, Australia and throughout Asia Pacific.”

Roche licenses PCR tech to Rosetta

Rosetta Genomics (Rehovot, Israel) said that its wholly owned U.S. subsidiary, Rosetta Genomics Inc. (North Brunswick, New Jersey), has received a license from Roche Molecular Systems to use its polymerase chain reaction (PCR) technology in the company’s microRNA-based diagnostic tests.

Rosetta Genomics said its microRNA detection platform, based on Roche PCR technology, allows the identification of microRNA biomarkers in several sample types and body fluids, “with very high sensitivity and specificity.”

“Based on the PCR platform, as well as other proprietary technologies, we are developing a line of highly sensitive microRNA-based products, three of which we expect will launch in 2008,” said Amir Avniel, president and CEO of Rosetta Genomics.” We have now been granted licenses from both Roche and Nanogen for use of their respective PCR technologies for diagnostic use, and are looking forward to the launch of our first microRNA-based diagnostic tests [this year].”

Rosetta said microRNAs are “naturally occurring small RNAs that act as master regulators and have the potential to form the basis for a new class of diagnostics and therapeutics.”

1st CyberKnife system coming to India

Accuray (Sunnyvale, California) said Healthcare Global Enterprise (HCG) has purchased a CyberKnife Robotic Radiosurgery System for its new oncology center in Bangalore, India. Upon installation in June, this will be the first CyberKnife System in India.

“Introducing CyberKnife treatment to India ... is a huge milestone in achieving broader access to the benefits of radiosurgery,” said Euan Thomson, PhD, president/CEO of Accuray. “The CyberKnife System that will be installed in Bangalore will provide a ... non-invasive cancer treatment option to the more than 1 million patients diagnosed with cancer in India every year.”

Accuray said it has established a wholly owned subsidiary headquartered in New Delhi.