A Diagnostics & Imaging Week

The Abbott Molecular unit of Abbott Laboratories (Abbott Park, Illinois) said it has introduced six CE-marked DNA tests in Europe for use by diagnostic laboratories in identifying chromosomal abnormalities associated with certain forms of leukemia.

The tests are based on Abbott's fluorescence in situ hybridization technology (FISH) and employ DNA probes used to detect genetic abnormalities, such as extra or rearranged chromosomes, common in patients with acute lymphocytic leukemia, chronic myeloid leukemia and chronic lymphocytic leukemia.

DNA probes are molecules stained with fluorescent dyes that recognize and bind to specific target molecules in patient samples. The fluorescent probes can be viewed under a special microscope, enabling the detection of chromosome gains, deletions or translocations.

According to the World Health Organization (Geneva, Switzerland), the global incidence of leukemia is about eight to nine per 100,000 people each year, with about 250,000 new cases occurring annually worldwide.

Abbott said the FISH tests are intended to supplement conventional cytogenetics (the analysis of chromosomes) and in some cases provide additional information not detected by other test methods. Conventional cytogenetics, for example, may indicate if large chromosome changes have occurred, whereas the FISH method targets specific, more cryptic chromosome defects known to be associated with cancers.

Both methods are needed to tell treating physicians whether a particular cancer is present or has recurred and to determine the patient's prognosis.

"Combining traditional cytogenetics with FISH testing provides doctors with the accurate information they need to make better decisions regarding treatment options and quality of life," said Professor Christine Harrison, director of the Leukemia Research Fund Cytogenetics Group at Southampton General Hospital in the UK.

Timothy Stenzel, MD, PhD, medical director at Abbott Molecular, said, "Certain genetic aberrations can be important indicators of whether a patient has a particularly aggressive form of leukemia or whether they will respond to certain therapies. Abbott's FISH technology helps physicians diagnose different leukemias that may look similar but have different genetic abnormalities and therefore may require different treatment."

The six probes that have received CE mark certification, allowing them to be commercially marketed in the European Union, include the Vysis LSI(R) p53/LSI ATM and LSI D13S319/LSI 13q34/CEP 12 Multi-Color Probe Sets; Vysis LSI BCR/ABL Dual Color, Dual Fusion Translocation Probe Set (20 assays and 50 assays); Vysis LSI BCR/ABL ES Dual Color Translocation Probe Set; Vysis LSI BCR/ABL Dual Color, Single Fusion Translocation Probe Set; Vysis LSI MLL Dual Color, Break Apart Rearrangement Probe; and Vysis LSI 21 SpectrumOrange Probe.

The six probes already are available in the U.S.

Vysis (Downers Grove, Illinois) is a unit of Abbott.

Abbot Molecular said these products represent the first in a series of CE-marked DNA probes that it expects to launch in Europe in the coming months. Future probes will be offered for a variety of applications in cancer and genetic testing.

Abbott Molecular is a developer of FISH probes, offering a broad menu of tests for use in cancer diagnostics and genetic testing.

China Medical, Century Medical team up

China Medical Technologies (Beijing), a medical device company that makes high intensity focused ultrasound (HIFU) products and advanced in-vitro diagnostic systems, said it has entered into an exclusive distribution agreement with Century Medical, a Japan-based medical device distributor wholly owned by Itochu (Tokyo) to distribute HIFU tumor therapy systems in Japan.

China Medical's HIFU tumor therapy systems will be exclusively marketed and distributed by Century Medical in Japan after the designated marketing authorization approval, or shonin, is obtained. Century will work together with China Medical to obtain the shonin from the Japanese Ministry of Health, Labor and Welfare. China Medical said it intends to use the data from the clinical trials to be conducted in the U.S. to apply for the shonin and will bear all costs.

Itochu is a major trading and investment conglomerate in Japan that was founded in 1858. Its wholly owned subsidiary, Century Medical, has more than 30 years of experience in the distribution of advanced medical devices, including extensive experience in import licensing, importation, inventory support, sales and marketing, and customer service.

Century's offerings include surgical products, interventional peripheral and neuron-radiology, cardiology and cardiovascular devices.

"We are very pleased to appoint Century Medical as the exclusive distributor of our HIFU tumor therapy system in Japan upon obtaining the shonin," said Xiaodong Wu, CEO and chairman of China Medical. "We believe this partnership marks an important milestone for China Medical as it takes advantage of the strengths of both companies and sets a foundation to support the long term growth of our business by expanding into one of the world's largest medical device markets. In addition, we will continue to explore other cooperation opportunities with Century Medical for medical device distribution in Japan."

"The forming of our strategic partnership with China Medical is based on a series of detailed and thorough evaluations. We look forward to working closely with China Medical to pave the way for our execution of a comprehensive marketing and distribution plan for the HIFU tumor therapy system in Japan. We believe China Medical's HIFU tumor therapy system will bring Japanese patients substantial benefits given its non-invasive characteristics," said Toshio Konishi, president/CEO of Century Medical.

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