Age-specific evaluation of HPV DNA testing vs. cytology screening

News brief: Age-specific evaluation of HPV DNA testing vs. cytology screeningContact: Steve Graff
jncimedia@oxfordjournals.org
301-841-1285
Journal of the National Cancer Institute

News brief: Age-specific evaluation of HPV DNA testing vs. cytology screening

Human papillomavirus (HPV) DNA testing with cytology triage is more sensitive than conventional cytology screening for detecting cervical lesions, according to a new study published online November 9 in the Journal of the National Cancer Institute. Cytology triage in HPV-positive women can improve specificity.

HPV DNA testing has shown higher sensitivity than conventional cytology screening for detecting cervical lesions, but it is uncertain whether the higher sensitivity is dependent on the age of the woman being screened.

Maarit Leinonen, M.D., of the Mass Screening Registry, Finnish Cancer Registry in Helsinki, and colleagues compared the age-specific performance of primary HPV DNA screening with that of conventional cytology screening. Finnish women aged 25-65 years were sent randomized invitations for HPV DNA testing with cytology triage or conventional screening.

Overall, primary HPV DNA screening with cytology triage was more sensitive than conventional screening for detecting cervical lesions. Among women younger than 35 years, those who got HPV DNA screening were referred for colposcopy more often than those who got conventional screening. Among women aged 35 years or older, HPV DNA testing with cytology triage was more sensitive and more specific than conventional screening, had a higher precision rate, and was associated with fewer colposcopy referrals and follow-up tests.

“In countries like Finland that have a well-organized cervical screening program and low incidence of cervical cancer, new interventions are expected to provide only small increases in a screening program’s efficacy,” the authors write. “Nevertheless, our results support the use of HPV DNA testing with cytology triage in primary cervical screening.”

In an accompanying editorial, Eduardo L. Franco, MPH, DrPH, said that “this finding underscores the importance of cytology as a triage test in preserving the specificity of the HPV DNA screening approach.”

He also suggests that use of an automated and objective molecular test, such as the HPV DNA assay, as an initial screening step increases the prevalence of abnormal smears destined for cytology reading, thus avoiding the monotony of reading smears in primary screening. In the post-vaccination era, when the prevalence of cervical abnormalities is expected to decrease, this enrichment step may preserve the positive predictive value of the HPV-followed-by Pap approach.

###

Contacts:
Article: Maarit Leinonen, maarit.leinonen@cancer.fi
Editorial: Eduardo Franco, eduardo.franco@mcgill.ca

DNAWellnessinfo.com Resource:  http://www.eurekalert.org/pub_releases/2009-11/jotn-nba110509.php

Sequenom says AttoSense HPV test was more precise

Associated Press, 07.14.09, 03:58 PM EDT

NEW YORK — Sequenom Inc. says a study shows its human papillomavirus DNA screen found significant infections in 15 percent of women who tested negative on a commonly used test.

The study compared Sequenom ( SQNM – news - people )’s AttoSense test to an older DNA-based HPV test called Hybrid Capture 2. Sequenom said its screen found 15 percent of women who tested negative on the HC2 test had “clinically relevant viral loads,” and nearly half of the women who tested negative had some level of HPV.

Certain strains of human papillomavirus, or HPV, are associated with most cases of cervical cancer. DNA tests and Pap smears are the most common ways to test for HPV, but Sequenom said Pap smears miss 10 to 20 percent of cases. The company estimated there are 9,000 new cases of cervical cancer in the U.S. each year, and 4,000 deaths from the disease.

Sequenom said 46.7 percent of the women had detectable levels of HPV, and 14.5 percent of the HC2 tests returned false positives for women who did not have any of the 13 types of HPV that are most strongly linked to cervical cancer.

The San Diego company said it plans to seek approval to market the AttoSense test in the U.S. and Europe “as soon as practical.” Currently it is available only for research use. Sequenom said AttoSense can detect and identify 15 strains of HPV.

The study included 199 cervical scrapings from women who were routinely screened for HPV using the HC2 test, and 77 tissue samples from tumors in confirmed cervical cancer patients.

The results were published by the University of Michigan, Sequenom said late Monday. Its shares rose 10 cents, or 3 percent, to $3.80 in afternoon trading.

Analyst Pamela Bassett of Cantor Fitzgerald said the study provides further support for Sequenom’s MassArray molecular diagnostics platform. She said the study is likely to be published in a virological journal in September.

Sequenom is also developing SEQureDx, a maternal blood test for Down syndrome. The company started new studies of the test earlier this year after discovering “employee mishandling” that made older, once-promising results unreliable.

Copyright 2009 Associated Press. All rights reserved. This material may not be published broadcast, rewritten, or redistributed.

DNAWellnessinfo.com Resource: http://www.forbes.com/feeds/ap/2009/07/14/ap6653799.html

First DNA Tests for HPV Approved

The virus associated with most cases of cervical cancer

FRIDAY, March 13 (HealthDay News) — The first DNA test to screen for two types of human papillomavirus (HPV) that are responsible for most cases of cervical cancer in the United States has been approved by the U.S. Food and Drug Administration.

The Cervista HPV 16/18 screens for the DNA sequences of HPV types 16 and 18 in cervical cells, the agency said in a news release.

A second newly approved diagnostic, the Cervista HPV HR test, can detect “essentially all of the high-risk HPV types in cervical cancer samples,” the FDA said.

HPV is the most common sexually transmitted infection in the United States, accounting for more than 6 million infections annually, the agency said. While most infected women do not develop complications, some HPV strains can cause cell abnormalities on the cervix lining that go on to become cancerous.

“Results from these two tests, when considered with a physician’s assessment of the patient’s history, other risk factors, and professional guidelines, can help physicians better determine risk and could lead to better patient management,” said Dr. Daniel G. Schultz, director of the FDA’s Center for Devices and Radiological Health.

The two tests are produced by Wisconsin-based Third Wave Technologies.

More information

To learn more about HPV, visit the U.S. Centers for Disease Control and Prevention.

DNA Nutritional Breakthrough:  http://www.dnaguidedwellnessproducts.com