A Diagnostics & Imaging Week

Agendia (Amsterdam, the Netherlands), a leading firm in the growing field of molecular diagnostics, said that an independent international consortium has demonstrated the prognostic power of the company’s MammaPrint breast cancer prognosis test in patients who have one to three positive lymph nodes.

The data show that MammaPrint can accurately identify a low-risk group of lymph node-positive breast cancer patients with an excellent survival, implications that Agendia said would help doctors to decide the optimal treatment management.

“Lymph node status is considered to be one of the most powerful prognostic factors for operable breast cancer, with a direct relationship between the number of positive nodes and disease outcome,” said Dr. Laura van’t Veer, chief research officer at Agendia. “However, approximately 30% of lymph node-positive patients will remain free of distant metastases without adjuvant chemotherapy,” she said.

van’t Veer, who participated in the study, added, “Identifying patients with lymph node-positive disease who are at low risk of recurrence might lead to changes in guidelines for adjuvant chemotherapy.”

In the study, 241 tumor samples from breast cancer patients with one to three positive lymph nodes at two hospitals were selected and analyzed by the international TRANSBIG consortium. Patients who were classified as “high risk” for recurrence using MammaPrint had “significantly worse” 5- and 10-year survival rates than those that were identified as low risk, according to the company.

Agendia said, “The numbers indicate that MammaPrint has excellent prognostic power, even in patients having one to three positive lymph nodes.” The study was presented as an oral presentation at the recent San Antonio Breast Cancer Symposium.

The company said it would start offering MammaPrint to patients having one to three positive lymph nodes in Europe and added that the data also would be submitted to the FDA for approval at a later date.

Isotope-producing reactor re-booted in Canada

Canada’s state-owned atomic energy company said earlier this week that it has reopened a nuclear reactor after that facility’s shutdown created a critical shortage of radioactive isotopes used to diagnose and treat cancer patients in Canada, the U.S. and many other nations.

The National Research Reactor, located at Chalk River, Ontario, provides half the world’s supply of the isotopes, which are used in about 25 million medical diagnoses and treatments each year.

The 50-year-old reactor was shut down Nov. 18 for maintenance and was scheduled to resume operation Nov. 23. But the Canadian Nuclear Safety Commission ordered an indefinite stoppage after discovering the reactor had been running for a year without the emergency power system being connected to two cooling pumps.

The reactor was safely returned to service last Sunday, Atomic Energy of Canada said. Officials expect to begin removing medical isotopes for processing and distribution within four days.

The announcement came just days after the Canadian government scrambled to pass legislation allowing the company to bypass Canada’s nuclear safety watchdog and re-start the reactor immediately.

The reactor produces a radioactive substance called molybdenum-99, which is processed and packaged into canisters for hospitals and pharmacies.

German hospital gets TomoTherapy system

TomoTherapy (Madison, Wisconsin) said that Helios Hospital Berlin-Buch has installed the TomoTherapy Hi-Art treatment system for advanced cancer care.

The company said the hospital wanted a rapid installation process, and it responded. The order was placed on Nov. 16 and the system was fully installed one month later. The first patient treatments are scheduled to begin the week of Jan. 21, TomoTherapy said.

Helios Hospital Berlin-Buch is the newest hospital constructed by the Helios Hospital Group, which TomoTherapy described as “the largest, most medically advanced hospital group in Germany.” Helios Hospital Group is a subsidiary of Fresenius ProServe, an international healthcare services and facilities management firm.

“The Helios Hospital Group is an ideal partner for us,” said Rik Van den Neste, MD, director of European sales for TomoTherapy. “They are a leader in the private hospital movement in Germany and committed to the most up-to-date medical care.”

Helios Hospital Berlin-Buch will become the seventh facility in Germany to install the TomoTherapy Hi-Art treatment system. The system was introduced in the U.S. in July 2003, and today there are more than 150 Hi-Art radiation therapy systems in use around the world.

The Hi-Art system combines integrated CT imaging with conformal radiation therapy to deliver sophisticated radiation treatments with speed and precision, TomoTherapy said, while reducing radiation exposure to surrounding healthy tissue.

Japan okays Sprint Quattro lead

Medtronic (Minneapolis) reported receipt of Japanese regulatory approval for the Sprint Quattro (Model 6944 and 6947) steroid-eluting right ventricular lead used with implantable cardioverter-defibrillators (ICDs) that detect and treat rapid and potentially lethal heart rhythms.

The Sprint Quattro 6947, with bipolar sensing and dual coil defibrillation, is Japan’s first 8.6 Fr defibrillation lead to feature screw-in fixation. Screw-in fixation offers flexibility in securing the ICD lead in various right ventricle locations. The company said it hopes to receive reimbursement for Sprint Quattro by Jan. 1, which would allow for its immediate launch in Japan.

Approved in Europe and the U.S. since 2001, the Sprint Quattro 6947 lead has a proven performance record and patient safety profile, the company said, with established sensing and defibrillation capabilities. The lead is used with various ICD and cardiac resynchronization therapy devices, such as the Medtronic Concerto CRT-D and the Virtuoso VR ICD, both of which were introduced in Japan in July.

Pat Mackin, president and senior VP for Medtronic’s Cardiac Rhythm Disease Management business, said, “The availability of the Quattro lead in Japan will provide Medtronic the opportunity to continue its market leadership in defibrillators and defibrillation leads in this important market.”

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