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Nanogen, DNAVision, Roche, CU Boulder, PerkinElmer

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Nanogen's POC Division Receives ISO Certification

Nanogen said last week that the International Organization of Standardization has certified the quality management system of its point-of-care division.

According to the San Diego-based molecular diagnostics company, the certification signifies that its point-of-care division has "quality management processes in place that have been assessed for their ability to meet customer and regulatory requirements."

Nanogen added that during the ISO review process, the company demonstrated that its quality management system complies with Canadian Medical Device Regulations as well.

The company said that attaining ISO registration is a "prerequisite for [its] point-of-care division to register its congestive heart failure product with Health Canada's Therapeutic Products Directorate."

"Nanogen's quality management system is also designed to conform to the US Food and Drug Administration's Center for Devices and Radiological Health's Quality System Regulations," the company said.

Nanogen discussed plans to attain Canadian and US approval for sale of its products during a third-quarter conference call last week (see story, this issue).


European Lab DNAVision to Offer Services with
Roche's AmpliChip CYP450; First for Europe

DNAVision will provide Roche Diagnostics' AmpliChip CYP450 chip in its European service offerings, the companies said last week.

The Brussels, Belgium-based private testing laboratory is the first company to provide the AmpliChip in Europe, the companies said.

The US Food and Drug Administration cleared the AmpliChip CYP450 test for diagnostic use earlier this year and in the European Union in September 2004 (see BAN 9/8/2004).

The test runs on Affymetrix's GeneChip platform.


CU Boulder's Flu Chip to Undergo Further CDC Testing

Researchers from the University of Colorado, Boulder, have developed a microarray-based test for the identification of influenza strains, and are collaborating with the US Centers for Disease Control and Prevention to prove the test's utility in rapid flu detection, according to a statement from the university.

CU Boulder reported this week that the CU-Boulder Flu Chip was recently evaluated by the CDC in Atlanta "for three primary subtypes of flu" in October, specifically "the avian flu strain H5N1, and two of the most common human flu types worldwide in recent winters, H1N1 and H3N2."

"The chip was more than 90 percent accurate and will be tested again with standard flu-virus culturing methods for accuracy and speed at the CDC's Atlanta headquarters next month," the university reported.

According to CU Boulder, its flu chip can process results in 11 hours. Kathy Rowlen, a CU investigator who helped engineer the chip, said that the university expects that its chip will be in wide-use in laboratories next year in a statement. The flu chip development team is also conferring with CU's Technology Transfer Office and plans to make the chip's genetic sequences freely available to interested researchers.

In addition, the team is working on making a simplified, more rapid test based on the array technology.

"We can make it small and simple enough to take into rural areas in places like the Congo, Cambodia or Indonesia that may lack lab facilities," Rowlen said. "One of our goals has been to address the needs of developing nations by providing an inexpensive, field-portable test kit for respiratory illnesses to the World Health Organization for global screening of respiratory illness."


PerkinElmer Obtains $350M Revolving Loan; Cash Could Fund M&A, Alliances

PerkinElmer obtained a $350-million unsecured revolving credit facility, the company said last week.

The five-year loan, which replaces a previous $100 million facility, will be used for "general corporate purposes," such as working capital, refinancing, capital expenditures, share repurchases, acquisitions, and strategic alliance, said PerkinElmer.

The facility was jointly made with Banc of America Securities and Citigroup Global Markets.