A Diagnostics & Imaging Week

Olympus (Tokyo) said a new manufacturing, research and development facility scheduled to open in Mishima, Japan, in 2007 would double its capacity to produce clinical analyzers. The new facility, which will be located at the base of Mt. Fuji, will serve the rapidly growing worldwide market for Olympus analyzers.

The new three-story facility will have nearly 161,500 square feet of space and is expected to cost about 4 billion yen ($35.7 million). It will replace the current facility, which has been in operation since 1978.

In addition to increasing manufacturing levels for Olympus diagnostic systems, the new building will incorporate a new global research and development facility. R&D efforts for the company’s diagnostic instruments product line have been co-located with manufacturing since 2000.

The Olympus line of analyzers includes the AU400, AU400e, AU640, AU640e, AU2700 and AU5400 chemistry analyzers, along with the AU3000i immunoassay analyzer. The latter system is expected to be available in the U.S. market in early 2006.

“The expanded manufacturing and R&D operation in Mishima will make it possible for Olympus to continue growing at a robust rate in the North American market,” said Stephen Wasserman, group vice president, Diagnostic Systems Group, Olympus America (Melville, New York). “We need the additional capacity to accommodate our current and planned rapid growth. The effects of this investment are vitally important for us, and will be beneficial for our customers in the U.S.”

MRSA screening pilot study begins in UK

GeneOhm Sciences (San Diego), a company involved in molecular-based diagnostics, reported the beginning of a year-long pilot study, commissioned by the UK Department of Health, of patient screening to detect colonization by methicillin-resistant Staphylococcus aureus (MRSA) in the National Health Service (NHS).

The program, which will be implemented at Birmingham Heartlands and Solihul NHS Trust, will include testing about 10,000 patients using GeneOhm’s IDI-MRSA rapid, molecular-based screening assay for identification of MRSA directly from patient specimens.

The IDI-MRSA assay is currently in use at numerous institutions in the UK, Europe and North America.

Birmingham Heartlands and Solihul NHS Trust, two UK hospitals, currently screen patients on admission for MRSA, but the medical staff waits 48 hours or more for results coming from tests based on traditional culture methods. The IDI-MRSA assay system can detect MRSA in less than two hours directly from the patient specimen.

MRSA infections have been shown to cause substantial illness and longer hospital stays. GeneOhm said that having “definitive results” for MRSA in hours instead of days “allows proper treatment to begin almost immediately, significantly improving outcomes while enabling institutions to better control overall costs of infections.”

Distributor set for Aperio products

Aperio Technologies (Vista, California), a provider of virtual microscopy systems, and the Photometrics (Tuc-son, Arizona) division of Roper Scientific have signed a distribution agreement whereby Nippon Roper, Roper’s Japanese subsidiary, will exclusively market and support Aperio’s line of ScanScope Systems in Japan and China.

The companies will launch their partnership at the fourth annual meeting of the Japanese Telepathology Society at Mie University on Friday.

Nippon Roper distributes imaging solutions from a number of companies, and said Aperio’s ScanScope Systems – microscope slide scanners for ultra-fast, entire-slide digitization, and software for viewing, managing and analyzing digital slides – strengthen its offering in the pathology sector.

“This partnership supports our strategic focus on advanced microscopy and pathology,” said Tom Connelly, president of Roper Scientific’s Advanced Microscopy business unit. “Aperio is the leader in virtual microscopy and has by far the largest installed base of products worldwide. We expect virtual microscopy to be extremely helpful to a medical community in which the relative number of pathologists is significantly lower than in other parts of the world.”

Virtual microscopy is the practice of converting entire glass microscope slides to high-resolution digital slides – images that can be remotely viewed, quantitatively analyzed and readily annotated, shared and managed, all without a traditional microscope.

ISO certification for R&D provider

Wipro Technologies (Bangalore, India), which describes itself as “the world’s largest third-party R&D services provider,” reported that it has received ISO 13485:2003 certification for design, development, conversion and maintenance of software and hardware systems for medical devices.

The certification was obtained after an external audit by Det Norske Veritas and specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services.

Wipro said it has been working with medical device companies in areas such as diagnostic imaging, image management solutions, patient monitoring, drug delivery, modality solutions and in vitro diagnostic device segments.

It provides verification and validation services, application/embedded software and hardware design services and regulatory compliance services for the medical device industry.

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