Swiss pharmaceutical giant Roche has been given the green light by US authorities to market its test for screening cervical cancer, the company announced on Wednesday.
The US Food and Drug Administration FDA has approved the cobas HPV (Human Papillomavirus) Test which identifies women with the highest risk of developing cervical cancer.
It is the only FDA-approved cervical cancer screening test that identifies genotypes 16 and 18, the two most aggressive forms of the potentially-fatal virus, at the same time as other high-risk forms, the company said.
Roche estimates that more than 55 million cervical smear tests are carried out in the US every year.
Last week the firm reported a nine percent fall in its first-quarter sales compared with a year ago, hurt by a strong Swiss franc.
Revenues for the first three months of the year reached 11.1 billion francs ($12.5 billion dollars, 8.6 billion euros).
The Basel-based group confirmed its full-year target, with group sales expected to grow at "low single-digit rates in local currencies."