A Medical Device Daily

Affymetrix (Santa Clara, California) reported that the University of Ottawa Heart Institute (UOHI; Ottawa, Ontario) is using the Affymetrix Genome-Wide Human SNP (single nucleotide polymorphisms) Array 6.0 for its whole-genome association study on coronary artery disease (CAD).

The company said that over the next three years, UOHI researchers will use the array to screen the DNA of more than 12,000 individuals not only to confirm their previous findings, but also to identify new associations that provide scientists with a better understanding of how to identify and develop personalized treatments for the causes of CAD.

With the SNP Array 6.0, researchers are able to use a single, whole-genome panel to analyze larger, multiple sample sets for both the initial scan and replication phases of an association study.

Scientists traditionally have performed initial genome scans using a high-density, whole-genome panel and then validating those results across a larger sample population with custom array technology that focused on a subset of SNPs. The whole-genome panel approach increases the overall genetic power of these studies and further accelerates the gene discovery process by enabling different groups to combine their data from different populations and disorders with overlapping phenotypes.

"Significant research underway at the UOHI will soon enable scientists to isolate, understand and target the trail of genetic activity that causes coronary artery disease, the leading killer in North America," said Robert Roberts, MD, president/CEO of the institute. "The Affymetrix SNP Array 6.0 is making these types of studies possible today."

In May, UOHI scientists used Affymetrix microarray technology to identify a DNA sequence associated with increased susceptibility to heart disease, by as much as 40%, regardless of other established risks such as cholesterol, blood pressure and diabetes. The team found that individuals carrying two copies of the genetic variant — about 25% of the population — had a 30% to 40% higher risk of heart disease and those carrying one copy (50% of Caucasians) have an increased risk of 15% to 20%.

This discovery could identify people of high risk for heart disease and enable early preventive therapies. The results of this study were published in Science and have since been confirmed in several independent Caucasian populations around the world.

New South African unit for bioMérieux

bioMérieux (Marcy L'Etoile, France), a global provider of in vitro diagnostics, reported the opening of a subsidiary in South Africa, based in Johannesburg. The new subsidiary will provide support to all of sub-Saharan Africa.

The subsidiary is bioMérieux's 36^th, representing what the company termed "another milestone" in its international expansion.

The company said that the move highlights the importance of South Africa for it. bioMérieux said its diagnostics solutions have been sold there by an exclusive distribution partner, Omnimed, since 2001. The Omnimed in vitro diagnostics team will be integrated into the new subsidiary and the two companies will continue to work closely together.

"With an historic commitment to the fight against infectious diseases, it is only natural for bioMérieux to reinforce our presence in South Africa," said CEO Stéphane Bancel. "We ... have been entrusted with all of the country's HIV viral load monitoring and will continue to provide molecular diagnostics and other advanced solutions to meet the region's healthcare challenges."

bioMérieux said it also is reinforcing its South African presence through partnerships with local research centers. The company will extend its customer training activities - involving more than 1,500 persons a year — to South Africa, investing in skills development programs for health workers, laboratory technicians and biologists.

Protecting patients from healthcare-associated infections also will be an area of focus for the company.

Lymphoseek gets patent allowance in Japan

Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, said that notification has been received by the University of California, San Diego (UCSD) regarding the allowance of the first patent covering Lymphoseek (technetium Tc99m DTPA-mannosyl-dextran) in Japan.

Lymphoseek is a radioactive lymphatic mapping targeting agent being developed by Neoprobe for use with hand-held gamma detection devices, such as the company's neo2000 system.

Neoprobe holds the exclusive rights to Lymphoseek under license from UCSD for use in diagnostic applications such as lymphatic mapping, as well as in ultrasound and optical imaging. Lymphoseek also is covered by patents previously issued to UCSD in June 2002 (U.S. patent 6,419,990) and in the European Union in November 2005.

After achieving what it termed "positive efficacy results" in recently completed Phase II multi-center clinical trials for Lymphoseek, the company said it is now moving forward with preparations for two Phase III clinical trials — one in breast cancer and one in melanoma.

Construction begins on Haemacure facility

Haemacure (Montreal) reported the start of construction of its manufacturing facility and the production of laboratory samples of fibrin sealant.

Construction is underway at the facility to prepare for the installation of a clean room. Haemacure said it is on plan to have an operational facility by mid-2008.

"Construction of new facility incorporating the latest proven manufacturing components is a major milestone that will require significantly lower capital investment than originally planned," the company said. The facility also will allow lower operating costs and higher final product safety standards.

Haemacure said it has produced in its laboratory samples of its fibrin sealant for delivery to potential partners for evaluation as a part of a collaboration program. "This will enable these partners to evaluate the product in their labs and see how it can enhance the performance of their own products, in wound management, regenerative medicine, drug delivery and combination with biomaterials applications," the company said.

Haemacure also reported adding Trung Bui-Khac, PhD, and Veronique Boulanger as new employees. Bui-Khac is a former VP of Haemacure and the inventor of three of the four inventions making up the company's fibrinogen and thrombin extraction technology. His new post is director of technical development. Boulanger is a senior scientist.