A Medical Device Daily

deCODE genetics (Reykjavik, Iceland) reported the launch deCODE MI, a reference laboratory test for variations in the genome (called SNPs) that the company has associated with increased risk of myocardial infarction, or heart attack.

The variants detected by deCODE MI are two SNPs on chromosome 9p21. They were discovered by company scientists earlier this year through genome-wide SNP analysis in Iceland and replicated in three cohorts of European descent from Philadelphia, Atlanta, and Durham, North Carolina.

Of the 17,000 patients and control subjects in the study, more than 20% of participants carried two copies of the variant, corresponding to a more than 60% increase in risk of heart attack, regardless of age of onset, compared to those without the variant.

In early-onset cases — men and women who suffered a heart attack before the ages of 50 and 60, respectively — carrying two copies of the variant corresponds to an approximate doubling of risk compared to non-carriers. The variant is estimated to account for about one-fifth of the incidence of heart attack in populations of European origin, and nearly one-third of early-onset cases, making it one of the most significant genetic risk factors found to date for heart attack, the company said.

deCODE said other researchers have replicated this finding in several European, U.S. and Canadian cohorts.

"With the launch of deCODE MI, we have taken another of our breakthroughs in genetics and transformed it into a new tool in the fight to prevent heart attack," said Dr. Kari Stefansson, CEO of deCODE. "While many risk factors for heart attack are understood, the disease remains the leading cause of death in the industrialized world and the early-onset cases often take both patients and doctors by surprise."

Stefansson said deCODE MI tests for a genetic risk factor that is independent of other risks such as cholesterol, obesity and smoking, "and therefore provides a means of identifying individuals who may derive particular benefit from earlier and more aggressive prevention efforts."

deCODE MI is performed in deCODE's CLIA-certified laboratory and must be authorized by a qualified physician.

South Korea okays sale of HIFU system

China Medical Technologies (Beijing), a manufacturer of in vitro diagnostic products and high-intensity focused ultrasound (HIFU) tumor therapy systems, reported receiving approval from the Korean FDA (KFDA) to market its HIFU tumor therapy system in South Korea for the treatment of liver cancer, pancreatic cancer and uterine fibroids.

"KFDA approval is another significant milestone in attaining international recognition for our HIFU system, particularly after having received conditional approval from the FDA in July to commence human clinical trials," said Xiaodong Wu, CEO and chairman. "We are ... excited about the opportunity to commence our HIFU sales outside of China."

China Medical said cancer is the leading cause of death in South Korea, with the number of Korean cancer patients increasing. It said introduction of its HIFU tumor therapy system to Korean hospitals will provide patients with a treatment alternative that can complement conventional approaches.

China Medical said its exclusive distributor will initially target the large general hospitals in that country to promote the HIFU tumor therapy system.

EMR contracts okayed in Ontario

Nightingale Informatix (Markham, Ontario), a provider of electronic medical record (EMR) software, reported contracts totaling about C$860,000 to provide its EMR solution to 41 OntarioMD-funded physicians at clinics in Scarborough, London, and Arnprior, Ontario.

Nightingale will license its EMR solution to each clinic, supply associated hardware and provide implementation, training and maintenance services. The initial contracts are for a three-year term, with an option to renew.

Nightingale had previously reported signing a 15-year agreement with OntarioMD for its Nightingale on Demand clinical management system. Primary care physicians across the province will be able to apply for funding through the Ministry of Health and Long-Term Care and Ontario Medical Association Physician Information Technology Program

"This agreement is a significant milestone for Nightingale," said Sam Chebib, president/CEO. "There are more than 22,000 physicians in Ontario, and studies show that the adoption rate for EMR is currently less than 20%."

U.S. firm acquires its Japanese j-v

Specialty Coating Systems (SCS; Indianapolis) has completed its acquisition of Parylene Japan KK (PJKK), a joint venture between it and Three Bond Co. that was established in 1990 to provide Parylene conformal coating services and technologies in Japan.

SCS said that sole ownership of PJKK enables it to leverage more of its capabilities to provide "the best service and support" for its global customers in the medical sector and other markets.

Specialty Coating will do business in Japan as Parylene Japan and will continue to be led by President Eddie Narita. The 10,000-square-foot Tokyo facility, ISO 9001:2000 certified, includes two Class 10K cleanrooms.

"Our customers in Japan will continue to receive outstanding Parylene coating services," said SCS President Terry Bush, "The acquisition of our long-term joint venture further establishes SCS's foothold in Asia."

ISO certification for Malaysian facility

Symmetry Medical (Warsaw, Indiana), a provider of products to the global orthopedics industry and other medical markets, reported receiving ISO 13485 certification in Malaysia, saying that this certification will allow it to fully implement its Total Solutions model and address the needs of the Asian market.

Michael Curtis, senior VP and general manager of Symmetry's Products Division, said, "The achievement of ISO 13485 certification at our manufacturing operation in Penang, Malaysia, is an important step in our growth strategy for the Asia-Pacific region. It signals to our Asia-Pacific customers that the excellent quality and service levels ... known throughout the rest of the Symmetry organization are recognized at the Malaysia facility."

Symmetry Medical opened its Malaysia facility last December.