A Medical Device Daily

While drug-eluting stent (DES) technology continues to travel a rocky road in U.S. and European markets, Boston Scientific (Natick, Massachusetts) is pushing ahead with its Taxus DES in international markets.

Yesterday the company reported receiving approval from the Japanese Ministry of Health, Labor and Welfare to market the TAXUS Express2 DES in that country. The company said it will not launch the product there until it receives approval of reimbursement.

Jim Tobin, president/CEO of Boston Scientific, said, "We are pleased to provide Japanese physicians with this proven technology, which will help improve the quality of life for so many patients."

Diamics lands $22M contract in China

Diamics (Novato, California), a private developer of cancer screening and diagnostics products, reported signing a three-year, $22 million-plus contract for the use and distribution of its system for cervical cancer screening in China.

It said that Beijing Jingmin Hospital Group will purchase at least 1 million tests a year. It will initially start with the company's CerCol collector, part of the Pap-Map cervical mapping system. The CerCol collector received FDA clearance in March.

"The government here has called for greater awareness, screening and treatment of women's health conditions, specifically, cervical cancer, and we are very pleased to be the first hospital to become a center of cervical cancer screening excellence," said James Shi, MD, of Beijing Jingmin Hospital.

Product registration in China is being funded and organized by Beijing Jingmin Hospital Group.

Once registered, the CerCol collector initially will be used in China in conjunction with the Diamics Transfer Station, to automatically create a "touch-prep" impression onto a pre-treated slide, which then can be processed by normal Pap staining methods.

Diamics said the Pap-Map technique is able to create a "map" of the sample collected from the cervix, providing the physician with Pap stain-qualitative aspects of abnormal areas of the cervix to help direct colposcopy and biopsies.

The second phase of the agreement will be triggered by the registration in China of Diamics' automated C-Map cervical cancer screening system, now in testing. Once registered, the C-MAP system — collector, transfer device, reagents and scanner — will replace the individual CerCol sales, with volumes reflective of the original three-year contract.

The C-Map system is a molecular-based diagnostic device being developed to allow for real-time, "see and treat" applications, Diamics said. It combines sampling with the CerCol collector and slide preparation with discreet immunological probes to determine the ratio between proliferating and apoptotic cells and by means of a third marker, identify cells that have been integrated by HPV.

Beijing Jingmin Hospital Group will target government institution sales and distribute via its associated hospitals to expand C-Map usage within China. Beyond their own hospital group use, they will have certain non-exclusive distribution rights for the C-MAP system in China.

"We are [pleased] to be working with the Beijing Jingmin Hospital Group and its affiliates to help women in China obtain proper screening for what is a highly treatable disease if caught early," said Christine Meda, Diamics' president/COO. "We anticipate that the C-Map system will be a key diagnostic tool in China and other developing countries, as we expect the automated system to offer a more specific, affordable result to women who presently do not have such access."

Diamics noted that China has a high incidence of cervical cancer and it has recently become a government priority to address the issue by promoting more widespread screening programs. Cancer of the cervix is the second-most-commonly-diagnosed cancer in women worldwide. About 500,000 new cases are diagnosed each year, 80% of which occur in developing countries.

Criticare in $2.2M Iraq sale

Criticare Systems (CSI; Milwaukee) reported the receipt of a $2.2 million international order for its next-generation portable multi-parameter vital signs monitor, winning a tender bid initiated by the ministry of health for the Republic of Iraq.

The order calls for payment via a letter of credit issued by the Trade Bank of Iraq, a bank owned by the government of Iraq and supported by a consortium led by JPMorgan Chase.

The company said it plans multiple shipments beginning in 4Q07, with completion anticipated in 1Q08.

CSI manufactures monitoring systems and noninvasive sensors for a wide range of hospitals and alternate healthcare environments throughout the world.

Joint venture for Charles River in China

Charles River Laboratories International (Wilmington, Massachusetts) said it has expanded its global footprint in Asia as part of its strategy to support customers' R&D efforts in this growing market.

It said the first phase of expansion includes the signing of a joint venture agreement with Shanghai BioExplorer (Shanghai, China), a provider of preclinical services, to form Charles River Laboratories Preclinical Services–China. The j-v will be majority owned and controlled by Charles River.

The transaction is subject to customary closing conditions, including Chinese regulatory approval, and is expected to close by the end of 2Q07.

As part of the agreement, Charles River will construct a 50,000-square-foot preclinical services facility in Shanghai. Expected to open in mid-2008, the facility will provide a range of discovery and development services, including GLP and non-GLP toxicology studies.

Genetic IP acquisition accord

UTEK (Tampa, Florida), a specialty finance company focused on technology transfer, and Genetic Technologies (Melbourne, Australia)), a life science company specializing in genetics and genomics, said they have signed a technology acquisition agreement.

UTEK will assist Genetic Technologies in identifying genetic analysis intellectual property developed by U.S.-based research entities that may be of interest to the Australian firm's genetic testing business. The initial focus of the relationship will be in the area of non-coding DNA analysis.

"We believe [this agreement] may assist us in expanding our proprietary position in the offering of 'non-coding' DNA-based genetic tests," said Mervyn Jacobson, CEO of Genetic Technologies.