A Diagnostics & Imaging Week

China Medical Technologies (Beijing) a manufacturer of in vitro diagnostic products, reported receiving Chinese State Food and Drug Administration (SFDA) approval for its Prenatal FISH Probe and Cervical Cancer FISH Probe.

The Prenatal FISH (fluorescent in situ hybridization) probe is a detection kit for the analysis of trisomies 13, 18 and 21 and sex chromosome aneusomies (X and Y).

The company said prenatal screening of trisomy 21 (Down syndrome) is becoming more prevalent in China and that its Prenatal FISH Probe can provide a quicker and more efficient confirmative approach to the prenatal screening results.

The Cervical Cancer FISH Probe is designed to detect the amplification of the TERC gene in human cervical tissue, which has been demonstrated to be associated with the severity of cervical disorders. Detection of the TERC amplification as a biomarker can provide better assessments of cervical disorders for clinical diagnosis, according to China Medical.

The company also reported that its Chinese subsidiaries have received approval for high-tech enterprise status from Beijing government authorities. With this status, the subsidiaries are entitled to an income tax rate of 15% instead of the statutory income tax rate of 25%. The status is valid for three years and will be eligible for renewal after evaluation by relevant government authorities every three years.

"We are pleased to receive SFDA approval for two of our FISH probes and achieve the high-tech enterprise status under new stringent criteria," said Chairman/CEO Xiaodong Wu. "With the SFDA approval, our hospital customers in different provinces can apply for the inclusion of the two FISH probes in the reimbursement menu of respective provincial medical insurance programs, which we believe will result in increased usage of the probes in the future."

He added that the high-tech enterprise status "demonstrates the government's recognition of our achievements in developing and manufacturing advanced innovative products. Furthermore, the ... government announced yesterday that an estimated amount of RMB850 billion will be spent in the next three years on healthcare reform initiatives, with a significant portion in medical insurance programs. We believe the IVD industry in China will strongly benefit from these initiatives."

Merge eyes gains in China

Merge Healthcare (Milwaukee, Wisconsin), a medical imaging solutions provider, said it has solidified the leadership team for its Chinese operations.

"Because of the opportunity in this market, Merge has moved quickly to solidify sales operations for ShanghaiCo, now doing business as Merge China," said CEO Justin Dearborn. "China has the potential to be our biggest market in a few years."

Merge cited Frost & Sullivan (F&S) statistics indicating that China holds one-fifth of the world's aging population. With a per-capita healthcare expenditure that increased by eight times from 1979 to 2004, China controls a large percentage of the world's healthcare spending, that company said.

It added that recent Chinese government initiatives have further sparked investment in healthcare resources, particularly to populations outside of the major metropolitan areas of China. F&S said this has resulted in a medical imaging growth rate that outpaces most of the world and that revenues from advanced modality sales alone are expected to reach $1.5 billion by 2010.

"With a unique ability to provide toolkits and technologies for local medical imaging companies, as well as finished applications focused on easy web access, Merge is well equipped to meet China's market needs," Dearborn said. "We are excited to be an active participant in this growth."

Merge China was reacquired after the dissolution of a transfer agreement to Inqgen Technology Co. earlier this month.

First German patients treated with RapidArc

Three prostate cancer patients have become the first persons in Germany to be treated using a new, faster form of radiotherapy that potentially enables doctors to improve outcomes while extending more advanced care to more patients. The faster treatment using RapidArc radiotherapy technology from Varian Medical Systems (Palo Alto, California) was delivered at Sudharz Krankenhaus (Nordhausen, Germany).

Varian said RapidArc "delivers a precise and efficient treatment in a single or multiple arcs of the treatment machine around the patient and makes it possible to deliver advanced image-guided intensity modulated radiotherapy (IMRT) two to eight times faster than is possible with conventional IMRT."

At Sudharz Krankenhaus Nordhausen, doctors have been able to reduce the treatment time to just 2-1/2 minutes compared with up to 30 minutes for complex IMRT treatments.

"It is very gratifying for me to begin treatments using the most modern moving arc method of radiotherapy," said Wolfgang Oehler, MD, head of the radiotherapy department. "The three patients are excited to be the first in Germany to receive such treatments although the treatment was so quick that one patient questioned whether he had received the full dose."

Oehler said RapidArc was a valuable weapon in the hospital's goal of bringing down waiting lists. "We knew we needed a ... new method of shortening treatment times and avoiding waiting lists while improving the quality of the treatment and it was not a hard decision to select RapidArc," he said.

Sudharz Krankenhaus treats up to 900 patients a year using two Varian Clinac linear accelerators. The hospital pioneered advanced IMRT treatments in Germany, carrying out the country's first such treatment in June 2001 and treating an additional 2,733 patients with the highly conformal technique in the eight years since.

With RapidArc, Varian's Clinac accelerator can target radiation beams at a tumor while continuously rotating around the patient. Conventional IMRT treatments are slower and more difficult for radiotherapy radiographers because they target tumors using a complex sequence of fixed beams from multiple angles.

Nucletron, RaySearch extend collaboration

RaySearch Laboratories (Stockholm, Sweden) and Nucletron (Veenendaal, the Netherlands) have extended an existing collaboration with two new treatment planning solutions for radiation therapy. According to a new development and license agreement, RaySearch will develop software modules for Model-Based Segmentation (MBS) and treatment planning of Volumetric Modulated Arc Therapy (VMAT) for Oncentra MasterPlan, Nucletron's multimodality treatment planning system.

VMAT is a relatively new and advanced form of Intensity Modulated Radiation Therapy (IMRT), in which the target is continuously irradiated while the source of the beam rotates around the patient in single or multiple arcs. This concept enables faster treatment delivery compared to traditional IMRT, where the patient is irradiated only from a few selected angles.

The new VMAT treatment planning solution will be integrated in the Oncentra Optimizer module of MasterPlan.

The companies said MBS facilitates the segmentation process when 3-D models of the tumor and surrounding organs at risk are created prior to the treatment planning process, traditionally a very time-consuming task as the contours are outlined manually.

Japanese distributor for TomoTherapy

TomoTherapy (Madison, Wisconsin) said it has entered into an exclusive agreement with Hitachi Medical (HMC; Tokyo) to distribute the company's Hi Art cancer treatment system in Japan.

HMC will market, sell and service the Hi Art system, which facilitates highly precise, CT-guided radiation therapy for a wide range of clinical indications.

"Hitachi Medical ... is an ideal partner for us and for our customers in one of our most important markets," said TomoTherapy CEO Fred Robertson, MD. "HMC's robust national infrastructure and reputation for excellent technical and customer support will enhance our ability to service all hospitals in Japan that are currently using TomoTherapy technology.

He added that the agreement represents a "significant opportunity for us to reach new customers, and help advance the quality of cancer care across Japan, the second-largest radiation therapy marketplace in the world."

"The TomoTherapy Hi Art system is being recognized as a novel radiation therapy system among Japanese customers," said Hitachi medical VP Michito Kinoshita. "We believe that we can contribute to quality improvement of radiation therapy for cancer treatment in Japan through distribution and technical service of this system. And, we are going to strengthen our presence in the market by adding this system in our product portfolio as we become able to provide not only diagnostic solutions but also a treatment solution for customers in Japan."