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.

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