A Diagnostics & Imaging Week

A strategic alliance has been reported that is aimed at delivering advanced technology and centralized cardiac safety testing services to the medical device and biopharmaceutical industries in Japan.

The parties to the alliance are Medifacts International (Rockville, Maryland) and Suzuken Co. Ltd. (Nagoya, Japan), one of Japan's largest cardiac safety services providers.

They said that companies in Japan now will have access to leading cardiac safety monitoring technology and services for the management of their clinical trials. That country is regarded as the world's third-largest market for pharmaceutical development,

Operating from centers in Nagoya, Sapporo and Tokyo as well as two sites in Shanghai, China, the alliance will provide what the companies termed "the most comprehensive and localized logistics, site support and data management in Asia for central electrocardiogram and ambulatory blood pressure monitoring collection services."

The alliance will provide more than 200 personnel – including a field support force of 130 equipment experts – from five shared facilities, supporting cardiac safety studies across Asia.

Medifacts President/CEO Michael Woehler said, "We are delighted to be working with an organization of the quality, expertise and reputation of Suzuken. Our strategic alliance sets a new standard in the service delivery of Japanese as well as global studies; and we are now able to provide our global clients with full service cardiac safety support operating from hubs in Japan, China, Europe and the Americas."

Boaz Mendzelevski, MD, Medifacts' director of cardiology and consultant to the pharmaceutical industry, said, "With the impending adoption of ICH E14 guidelines in Japan, Japanese and global biopharmaceutical companies are going to be confronted with an immediate need to address complex new regulations across the entire range of development activities."

Cervical cancer screening set in India

Qiagen (Venlo, the Netherlands) and Chittaranjan National Cancer Institute (CNCI; Kolkata, India) have reported a collaboration to establish the first large-scale cervical cancer screening program for women in Kolkata.

Qiagen will provide its diagnostic tests for the human papillomavirus virus (HPV), the primary cause of cervical cancer. CNCI will conduct the screening and provide appropriate treatment as needed.

Financial terms were not disclosed.

The QiagenCares Kolkata Project will use Qiagen's hybrid capture 2 (hc2) HPV DNA testing technology, also known as the digene HPV Test, to screen women for cancer-causing types of HPV to identify those with or at risk for developing cervical cancer.

Participating women also will be screened using VIA (visual inspection with acetic acid), as per the Indian National Guidelines for Cervical Screening. Screening will take place at community-based mobile field clinics in the villages neighboring Kolkata. Women found to have cervical cancer or pre-cancer will be immediately treated at the field clinic or referred to the CNCI for follow up.

The project also includes educational campaigns to raise awareness about HPV, cervical cancer, and other women's health issues. The initiative will be conducted over five years and is expected to reach 50,000 women.

Qiagen CEO Peer Schatz said, "Kolkata, India, is a particularly fitting location to launch this project as India has the world's highest incidence rate of cervical cancer. We believe that launching this project can play a role in helping to change those statistics."

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