BASEL, Switzerland – Swiss drug giant Roche Holding said Wednesday that it won U.S. regulatory approval for a novel diagnostic test that can help establish early whether women are at risk of developing cervical cancer, the most frequent cancer in females after breast cancer.
“This is a great achievement for us. The test is fully automated, has a high reliability and throughput rate," said Daniel O'Day, who heads Roche's diagnostics division. He expects the test to boost the division’s sales, which had revenues of $11.6 billion in 2010.
Shares of Roche gained one percent in Swiss trading.
The U.S. Food and Drug Administration backed Roche’s so-called cobas HPV test after reviewing clinical data involving some 47,000 women who were tested for infection with several forms of human papillomavirus (HPV). According to medical data, four out of five women are exposed at least once to HPV during their lifetime.
HPV is the key cause of cervical cancer, which affects more than 500,000 women worldwide every year, according to data from the World Health Organization. While the disease can be treated if spotted early, the mortality rate is high when the cancer is diagnosed too late. More than 280,000 women die of the disease every year. Breast cancer kills more than 500,000 women every year.
It was a major advancement on the standard smear test, after trials found the cobas test spotted that one out of 10 women actually had cervical pre-cancer after smear tests indicated they were healthy. Also, in contrast to other automated tests, the cobas test can find whether a woman carries either of the two genotypes of HPV that are responsible for about 70 percent of all cervical cancer cases, thus saving costs and time for patients, O’Day added.