Medical Device Link.

TRENDS & PERSPECTIVES

■ Eurogentec (Liège, Belgium) recently received ISO 13485:2003 certification for the production and sales of IVD oligonucleotides. The ISO 13485 certification provides added assurance to clients that the company has established highly reliable, effective, and reproducible processes for manufacturing of oligonucleotides used in molecular diagnostic devices and lab-developed tests.

■ BioMérieux (Marcy l’Etoile, France) entered into an exclusive referral agreement with ICNet Systems Inc. (Gloucestershire, UK) earlier this year. ICNet Systems Inc. is an international provider of healthcare-associated infection case-management and surveillance software. The Web-enabled application helps hospitals reduce medication costs through the more expeditious and appropriate use of real-time microbiology diagnostic data management, surveillance, and reporting. The use of the software reportedly can assist in decreasing the risk of spreading preventable infections.

■ Artemis Health Inc. (Menlo Park, CA) has acquired a coexclusive worldwide license from Stanford University to develop cell-free fetal DNA prenatal diagnostic tests. The technology is based on research from the lab of Stephen Quake, PhD, cochair of the department of bioengineering. The license expands Artemis’s clinical and research program and will allow the company to develop a noninvasive prenatal blood test that accurately predicts chromosomal and genetic disorders.

■ CombiMatrix Corp. (Mukiteo, WA) announced today that its subsidiary CombiMatrix Molecular Diagnostics (CMDX) has entered into a new partnership with Lenetix, a New York–based laboratory, to market CMDX’s suite of array CGH based–tests. These tests include the BAC HD scan, a comprehensive test for characterizing genomic causes of childhood developmental disorders. It can identify more than 290 genomic causes of developmental disorders and is routinely used in postnatal genetic diagnostics.