Diagnostics & Imaging Week International Editor
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A U.S. federal court has denied an injunction filed by Siemens Medical Solutions (Malvern, Pennsylvania) to stop Saint-Gobain Ceramics & Plastics (Courbevoie, France) from marketing and distributing advanced crystals that are a key competitive advantage for Siemens’ top-of-the-line diagnostic imaging systems.

Siemens sued Saint-Gobain in April 2007 for infringement of a 1990 patent it holds on lutetium oxyorthosilicate (LSO) crystals that are an essential detector used for its 3D positron-emission tomography (PET) technology that is at the heart of the Biograph and Excel imaging systems.

A federal judge in Wilmington, Delaware, wrote on Jan. 8 that “Although plaintiff adduced evidence that ultimately may demonstrate infringement,” the case at this stage “does not weigh predominantly in plaintiff’s favor,” according to a Bloomberg report.

A Saint-Gobain spokesman said the company is “pleased” with the decision but declined to comment further, Bloomberg said.

A Siemens spokesman told Health Imaging News that it “is vigorously pursuing its lawsuit and looks forward to the jury trial in September.”

At the center of the dispute is the Saint-Gobain PreLude 420, an LSO crystal that Siemens claims is equivalent in its ability to give scanning arrays a faster throughput rates than competing technologies and thereby enable high-speed full body PET scans.

Higher patient processing counts for Siemens Biograph machines are a key selling point for the $3 million units. Siemens promotes its Biograph TruePoint scanners as three times faster than competing lines and the company claims a record 11 patients were scanned in one day at the Northern California PET Imaging Center with an average scan time of 35 minutes.

Improvements in crystals used for reading radiation have been a driver in the PET scanner market as the industry responds to greater demand. LSO crystals have a faster scintillation decay time and a higher percentage of relative light output than the more commonly installed bismuth germanium oxide crystals in units sold, for example, by GE Healthcare (Waukesha, Wisconsin) in its Discovery scanners.

Saint-Gobain Ceramics & Plastics is part of the $52 billion Saint-Gobain group, one of the top 100 industrial companies in the world. The LSO crystal arrays used in the company’s scintillation products sold for medical imaging are manufactured in Newbury, Ohio, Nemours France, and Soest, the Netherlands.

Saint-Gobain Crystals is said to be the world’s largest producer of detectors for nuclear medicine gamma camera imaging systems and produced scintillation detectors for the Lunar Prospector and MARS Odyssey probes.

Sysmex, bioMérieux form Japanese j-v

Sysmex (Kobe, Japan) and bioMérieux (Marcy L’Etoile, France) said they have signed an agreement by which Sysmex will take a 34% equity stake in bioMérieux Japan.

The new company, called Sysmex bioMérieux Co. Ltd., will promote and commercialize the entire bioMérieux product line in Japan starting April 1. The joint venture will manage the regulatory filing and marketing activities of bioMérieux products in Japan.

Sales and customer service activities will be contracted out from the j-v to Sysmex, which is a world leader in clinical laboratory testing of blood, urine and other specimens, providing instruments and reagents for clinical laboratory testing as well as laboratory information systems as part of a comprehensive service and support system.

A major global player in in vitro diagnostics, bioMérieux has a leadership position in microbiology analysis, with a comprehensive offering of products for streamlined workflow and improved quality in microbiology testing.

Microbiology testing is commonly practiced to identify causative bacteria and to measure their susceptibility to certain antibiotics or drugs for the diagnosis and treatment of patients suspected of having infectious diseases.

Market volume for microbiology testing in Japan is estimated at about 30 billion Japanese yen per year and is the second-largest in size worldwide.

Sysmex and bioMérieux have been developing their global partnership since last July, when bioMérieux became a global partner to distribute Sysmex’s automated UF-1000i urine sediment analyzer to its extensive clinical microbiology customer base. This new venture reinforces the long-standing partnership between the two companies.

bioMérieux CEO Stéphane Bancel said, “We could not have found a better partner for this key market. bioMérieux Japan is No. 19 in the Japanese IVD market, while bioMérieux is No. 7 worldwide. We have been lacking scale in several critical functions [such as] commercial operations and customer service. By partnering with the No. 1 diagnostics company in the Japanese market, we will bring [our] products to a broader customer base.”

Calypte’s Chinese j-v gets manufacturing license

Calypte Biomedical (Lake Oswego, Oregon), a maker of HIV diagnostic tests, said its Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Co., has received a permit to manufacture medical devices issued by the Beijing branch of the State Food and Drug and Administration (SFDA).

The manufacturing permit enables the facility to manufacture in vitro diagnostic tests for the domestic Chinese market once specific product approval is received. The permit is required before Beijing Marr can sell an approved product within China.

Calypte said Beijing Marr is awaiting approval from the SFDA to distribute and sell Calypte’s Aware HIV-1/2 OMT rapid diagnostic test within China.

Beijing Marr is a joint venture between Calypte and a Marr Group subsidiary, established to manufacture Calypte’s Aware line of rapid HIV tests, including the Aware HIV-1/2 OMT product for both the Chinese and international markets.

Aware HIV-1/2 OMT is a rapid test using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes, with an accuracy comparable to that of U.S. FDA-approved, blood-based laboratory HIV EIA tests, according to the company.

Roger Gale, Calypte president/CEO, said, “Coming on the heels of the recent ISO 13485 certification of Beijing Marr’s manufacturing facility, this permit is another significant milestone that brings us much closer to our objective of manufacturing and marketing our rapid test product for the Chinese market.”

Beijing Marr CEO David Harris, said, “This permit is required because the State Food and Drug Administration moved regulatory oversight for HIV tests from the Drug Division to the Medical Device Division. Our team has been working diligently to obtain this permit to ensure that we will be permitted to manufacture our Aware HIV-1/2 OMT test once it has been approved for sale in China.”

Belgian fund buying Israeli radiology retrofitter

The private investment fund Quaeroq (Waregem, Belgium) has taken a 10% stake in the CMT Medical Technologies (Yokneam, Israel) and said it plans to continue investing, although it denied it seeks a takeover. For the moment Quaeroq said it will seek a seat on the CMT board of directors.

The core business of CMT Medical is radiographic and fluoroscopic imaging systems, angiography, digital radiography and cardiac imaging. The company’s SmartRAD family of products have both FDA clearance and the CE mark, and are offered both as a retrofit system for existing hospital X-ray systems or as a digital subsystem for original equipment manufacturers.

SmartRAD is designed to be compatible with existing general radiology clinics which retrofit a flat-panel detector as an alternative to traditional film screen and computed radiography. The updated system increases patient throughput by more than 30%, while reducing exposure to radiation both for patients and operators.

CMT Medical reported 2006 revenues of 118.5 million ($27 million) and is capitalized on the Euronext exchange in Paris at 115 million ($28.7 million).

Almost two-thirds of sales are from the Far East, with North America accounting for another fourth. Europe makes up 7% of sales.