A Medical Device Daily

Affymetrix (Santa Clara, California) said that South Korea’s National Institute of Health (KNIH) and Center for Disease Control and Prevention will use the company’s Genome-Wide Human SNP Array 5.0 for the Korean Association REsource (KARE) project.

SeouLin Bioscience will supply the Affymetrix microarray technology and will provide technical support to the Korea NIH.

The genome-wide association study is designed to identify the genetic causes of lifestyle-related complex diseases that are prevalent in South Korea. Affymetrix said the KARE project is expected to be “one of the world’s most recognizable clinical research projects.” Researchers will use the firm’s microarray technology to generate individual genotypes from more than 10,000 human DNA samples.

The SNP Array 5.0 is a single microarray featuring more than 500,000 single nucleotide polymorphisms (SNPs) and 420,000 additional non-polymorphic probes that can measure other genetic differences, such as copy number variation. Affymetrix said researchers are using the array to better identify and understand complex diseases such as autism, autoimmunity, bipolar disease, cancer, diabetes and heart disease.

The company said the technology “enables researchers to perform more powerful whole-genome association studies, increasing the probability of discovering genes associated with adverse drug response or complex disorders.” The resulting information will be made available as part of a database to help inspire additional research projects.

“Using the new Affymetrix SNP Array 5.0, we will be able to perform a true, unbiased genome-wide association study. This project will enable us to uncover the genes associated with diseases such as metabolic syndrome that affect many individuals in Korea,” said Bermseok Oh, PhD, chief, Division of Structural and Functional Genomics at KNIH. “We feel these studies can improve the quality of life by helping us develop cost-effective therapeutics and personalized preventative measures.”

The KARE project will use samples from the prospective epidemiological Ansan and Ansung cohorts in Korea. It is comparable to the SHARE (SNP Health Association REsource) project, a U.S.-based study that also is using Affymetrix technology to identify genetic variants associated with heart, lung, blood and sleep disorders.

In South Korea, the microarrays will be run in the high-throughput lab of DNA Link , an Affymetrix-certified service provider.

Canadian product approval for Cynosure

Cynosure (Westford, Massachusetts), maker of a broad array of light-based aesthetic treatment systems, said it has received clearance to market and sell the Smartlipo LaserBodySculpting Workstation in that country.

President/CEO Michael Davin said, “With this approval, all five of our flagship products, including the Affirm Anti-Aging Workstation, the Cynergy Vascular Workstation, the TriActive Cellulite Workstation and the Elite Aesthetic Workstation are being marketed in Canada, enabling us to offer the Canadian medical community a comprehensive range of aesthetic and anti-aging solutions.”

Introduced by Cynosure in January, the minimally invasive Smartlipo Workstation is designed as an alternative to traditional liposuction in patients with smaller areas of localized fat. Its pulsing format delivers laser energy that liquefies localized deposits of fat that is then removed through a cannula. The laser energy also coagulates the tissue, thus sculpting body contours and tightening the skin.

The company said the procedure generally causes less bleeding, swelling and bruising than traditional liposuction, resulting in fewer complications and faster recovery. Cynosure received FDA clearance to market Smartlipo in 4Q06.

Dr. Barry Lycka, a well-known cosmetic dermatologist and surgeon who practices in Edmonton, Alberta, said, “By enhancing a patient’s appearance, the Smartlipo Workstation has the ability to improve overall quality of life, without the potentially serious complications and lengthy recovery times of traditional liposuction. Smartlipo’s ability to target localized deposits of fat and treat multiple areas in a single session makes this an exciting and promising technology.”

The Smartlipo family of products includes a 6-watt workstation as well as a newly launched 10-watt workstation designed for higher-volume aesthetic practices.

New Zealand firm in Henry Schein’s sights

Henry Schein (Melville, New York), which characterizes itself as the largest provider of healthcare products and services to office-based practitioners in the combined North American and European markets, reported its intent to make an offer to acquire Software of Excellence International (SOE), a publicly listed New Zealand company with revenue from continuing operations of about $19.1 million for its year ended March 31.

Henry Schein said it intends to offer NZ$2.70 per share to Software of Excellence shareholders, after payment of a dividend of NZ$.03 per share. It said the combined offer price and dividend represents a 27% premium based on the closing price of SOE shares on April 27, the last trading day prior to when Software of Excellence made public the disclosure of a potential acquisition.

If completed, the total purchase price excluding transaction costs will be NZ$77.2 million (about $58 million), and is expected to be paid in cash.

“Software of Excellence is well respected in these markets and will be an important addition to [our] current technology platform, enhancing the value-added services proposition to our customers,” said Stanley Bergman, chairman and CEO of Henry Schein. “Our intention would be to have the management team of Software of Excellence join Henry Schein and keep Software of Excellence’s existing infrastructure substantially intact.”

IDSI at Chinese breast imaging conference

Imaging Diagnostic Systems (IDSI; Fort Lauderdale, Florida), a developer of laser optical breast imaging systems, said it participated in the 2nd National Imaging Diagnostic Conference on Breast Disease in Qingdao, China, late last month. The company said the conference is considered the most important venue on breast disease in China.

Jing Jie Zhuang, managing director of IDSI Beijing , said, “We are pleased with the growing interest we are seeing as we build our clinical presence in China. Having a direct office in Beijing has greatly helped [us] establish close relations with leading Chinese breast specialists for both research and commercial opportunities.”

The company has received approval for the CTLM system from the State Food and Drug Administration of China.

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