PLEASANTON, Calif.—Roche Molecular Systems and the German Cancer Research Center (DKFZ) have entered into a research collaboration to enable more specific prediction of a woman's risk for developing cervical cancer. Financial terms of the deal were not disclosed.
RMD and DKFZ initiated the three-year collaboration in September. DKFZ is conducting research on Roche proprietary platforms, facilitating direct transition and application of any relevant findings to the Roche diagnostics product line.
Dr. Paul Brown, president and CEO of Roche Molecular Diagnostics, says DKFZ proved to be the right fit for this collaboration because it is "among the world's leading HPV research institutes." The center is the largest biomedical research institute in Germany and is a member of the Helmholtz Association of National Research Centers. More than 2,200 staff members, including 1,000 scientists, are investigating the mechanisms of cancer and are working to identify cancer risk factors.
"Through this collaboration, we have the opportunity to work with them to further improve screening and diagnosis of cervical cancer," Brown says.
Dr. Ruth Herzog, head of the Office of Technology Transfer for DKFZ, says the collaboration is based on recent DKFZ research indicating that the relative amounts of specific spliced viral RNA molecules (i.e., RNA markers) in HPV-infected cells enable highly accurate discrimination of cervical cancer and high-grade (pre-cancer) from low-grade cervical lesions.
"RMD is a global leader in in vitro diagnostics (IVDs), so we expect them to have the power to bring the product-to-be to the market," Herzog says. "Further, they convinced us with their professionalism and their commitment to HPV research and women's health."
According to DKFZ Professor Lutz Gissmann, from previous laboratory results on HPV RNA patterns, researchers believe their test system will specifically and reliably detect women at high risk for cervical cancer.
"With Roche, we have the great opportunity to work with a strong and experienced development partner for translating our laboratory results into a valid diagnostic product from which women will benefit," Gissmann says.
Moreover, Brown points out that the ATHENA U.S. registration trial demonstrated clearly the sensitivity and diagnostic value that HPV DNA testing provides compared to cytologic examination with a traditional Pap test.
Brown says the type of innovative HPV research ongoing at DKFZ is completely aligned with Roche's mission. The company currently has the cobas 4800 HPV test, which tests for 12 high-risk HPV types. The test was launched in Europe last year, but is not available in the United States.
"As a company, Roche is committed to continuing this type of groundbreaking HPV research to improve diagnosis of cervical cancer and save women's lives," he adds. "Our hope is that this will ultimately lead to the development of a new test to make cervical cancer screening, diagnosis and grading even more accurate and specific."
Persistent infection with human papillomavirus is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. Of the more than 118 different types of HPV, 13-16 types are currently considered high-risk for the development of cervical cancer and its precursor lesions. HPV types 16 and 18 have been identified as the highest risk genotypes, detected in approximately 70 percent of cervical cancers. Nucleic acid (DNA) testing is a sensitive and non-invasive method for determining the presence of a cervical HPV infection.
