Trade News
Basel, June 23, 2005
Roche Diagnostics
Receives CE Mark Certification for HPV Genotyping Test
New test
identifies 37 high- and low-risk human papillomavirus genotypes
Roche
Diagnostics announced today that it has received CE Mark* certification for
its new Linear Array HPV
Genotyping Test1, allowing Roche Diagnostics to sell the test in the European
Union and other countries
that accept CE Mark certification. This test identifies 37 high- and low-risk Human Papillomavirus (HPV)
genotypes, including those considered a significant risk factor for progression to cervical cancer.
The test is the first HPV genotyping test kit to be registered for in vitro diagnostic use.
"The
accurate identification of high-risk HPV genotypes is a major step forward
in defining a woman’s risk
of progression to cervical cancer. The Linear Array HPV Genotyping Test will help physicians’ determine
the best treatment options for their patients." states Heino von Prondzynski, CEO of Division Roche
Diagnostics and Member of the Executive Committee. "Since we acquired the broad HPV patent portfolio
from the Institut Pasteur in June 2002, we have made major strides in bringing innovative tests to market,
tests designed to bring actionable health information to doctors and patients."
The
test complements existing HPV screening tests, such as the Roche Diagnostics Amplicor HPV Test2
by identifying
which HPV genotype is present in the patient sample. Reported potential applications for HPV genotyping
include clinical evaluation of the infection with and clearance of specific HPV types3;
monitoring the
persistence of high-risk infections4; evaluation of the effectiveness of
excisional therapy5, radiation
treatment6, and chemotherapy7; pre- and post-vaccine
evaluation8; and facilitation of epidemiological
studies.
The Roche Diagnostics’ Linear Array HPV Genotyping Test
uses amplification of target DNA by PCR (polymerase chain reaction) and nucleic acid hybridization to
detect 37 anogenital high- and low-risk HPV DNA genotypes. Among the 13 HPV genotypes known to be high-risk,
there are several, such as genotypes 16 and 18, that account for more than two-thirds of all cervical
cancer cases.
"Roche Diagnostics’ new genotyping
test may prove
very useful for physicians treating HPV-associated lesions, especially in light of recent research suggesting
that certain high-risk types of HPV, such as genotype 16, may be substantially more persistent and predictive
of high-grade neoplasia than other high-risk types," said Joseph Monsonego, M.D., President
of
the European Research Organization on Genital Infection and Neoplasia (EUROGIN) and Chief Medical Director,
Department of Cytocolposcopic Screening and HPV Clinical Research Unit, Institut Alfred Fournier (Paris).
About
HPV
There are more than 100 different genotypes of human papillomavirus, and more
than 30 different HPV types that can infect the human genital mucosa. Although the majority of HPV infections
clear spontaneously, persistent infection with known high-risk HPV types is a significant risk factor
for cervical cancer, and is increasingly recognized for its role in other cancers.
According
to the World Health Organization (WHO), cervical cancer is the second most common cause of cancer death
in women. The presence of HPV infection has been implicated in more than 99% of cervical cancers worldwide.
Every year, more than 493,000 women worldwide develop cervical cancer, and more than 273,000 die from
the disease. Even with Pap screening programs, a significant number of women die from cervical cancer
each year.
About Roche and the Roche Diagnostics Division
Headquartered
in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the
fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the
early detection, 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 is a world leader in diagnostics,
the leading supplier of medicines for cancer and transplantation and a market leader in virology. In
2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics
Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries
and has R&D agreements and strategic alliances with numerous partners, including majority ownership
interests in Genentech and Chugai.
Roche’s Diagnostics Division offers
a uniquely broad product portfolio and supplies a wide array of innovative testing products and services
to researchers, physicians, patients, hospitals and laboratories world-wide. For further information,
please visit our website www.roche-diagnostics.com.
*
"Conformité
Européenne - allowing the test to be used for diagnostic purposes in the European Union
1
Not available in the United States.
2 Not
available in the United States.
3
Richardson, H., et al. 2003. The Natural History of Type-Specific Human Papillomavirus Infections in
Female University Students. Cancer Epidemiology Biomarkers & Prevention, Vol. 12: 485-490.
4
Kjaer, S., et al. 2002. Type specific persistence of high risk human papillomavirus (HPV) as indicator
of high grade cervical squamous intraepithelial lesions in young women: population based prospective
follow up study. BMJ. Vol. 325: 572.
5 Costa,
S., et al. 2003. Factors
predicting human papillomavirus clearance in cervical intraepithelial neoplasia lesions treated by conization.
Gynecologic Oncology, 2003, August; 90 (2):358-365
6
Yutaka, N., et
al. 2004. Persistence of human papillomavirus infection as a predictor for recurrence in carcinoma of
the cervix after radiotherapy. American Journal of Obstetrics and Gynecology, 2004, 191, 1907-1913
7
Nobeyama, H., et al. 2004. Association of HPV infection with prognosis after neoadjuvant chemotherapy
in advanced uterine cervical cancer. International Journal of Molecular Medicine, 2004, July; 14(1):101-105
8
Koutsky, L., et al. 2002. A Controlled Trial of a Human Papillomavirus Type 16 Vaccine, NEJM, Vol. 347(21):1645-1651.