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Media Release

Basel, 19 April 2004

Amplicor HPV, new diagnostic test to detect cancer causing viruses, launched in Europe
Amplicor HPV, first PCR-based test kit, detects all 13 high-risk DNA genotypes of human papillomavirus (HPV), the leading cause of cervical cancer

Roche today announced the launch of its Amplicor Human Papillomavirus (HPV) test kit in the European Union, an important landmark in the development of its global women’s health portfolio. The new Amplicor HPV kit with CE marking (“Conformité Européene”) for in-vitro diagnostics is the first PCR-based (polymerase chain reaction) reagent for the detection of HPV. This new test identifies all 13 high-risk genotypes of HPV, which is the leading cause of cervical cancer affecting more than 500,000 women worldwide every year.

“There is a large unmet medical need to enhance diagnosis of cervical cancer through the use of an HPV PCR test,” said Heino von Prondzynski, Head of Roche Diagnostics and Member of the Roche Executive Committee. “The Pap test alone is only about 80% effective in detecting the precursors of cervical cancer. Furthermore, the presence of a cervical precancer is unclear in a significant percentage of ‘inconclusive’ Pap tests. HPV PCR tests can help resolve these inconclusive tests.
Women in Europe can benefit from this innovative test as of now.”

Roche Diagnostics is also developing a PCR-based linear array HPV product, based on a proven format used by more than 30 laboratories globally. The linear array identifies 37 HPV genotypes, including all high- and low-risk genotypes in the anogenital region. Potential clinical applications for the linear array HPV product include confirmation of positive screening results, follow-up of positive results, and providing subtype (genotype) information that will assist physicians with choosing the next steps for treatment. Discoveries about HPV and cervical cancer conducted with the aid of Roche’s linear array HPV product have been published in many leading peer-reviewed medical and scientific journals, including “The Lancet” and “Cancer”.

About Cervical Cancer Screening and HPV
According to the World Health Organization, cervical cancer is the second biggest cause of female cancer mortality worldwide with close to 300,000 deaths yearly. In the absence of screening programs (routine Pap smear), cervical cancer may be detected at later stages, with poor prognosis. Almost all (99.8%) cervical cancers are caused by specific types of a sexually-transmitted DNA tumor virus called human papillomavirus (HPV). To screen for cervical cancer, 160 million Pap tests are performed each year worldwide. Through the approval of reimbursement initiatives for HPV screening, governments in European countries are now recognizing the importance of HPV screening in preventing cervical cancer.

About Roche and Roche Diagnostics
Headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Diagnostics Division, the world leader in in-vitro diagnostics with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories worldwide.

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