Roche wins approval of HPV test

Roche Diagnostics Corp. won regulatory approval for a new HPV test, giving it a technological edge in the $300 million market for automated cervical cancer tests.

The Swiss giant, which runs its U.S. operations out of Indianapolis, will offer the HPV test as part of its cobas 4800 system of medical laboratory analyzers.

HPV, or human papillomavirus, is the leading cause of cervical cancer, which afflicts 12,000 new women every year in the United States, leading to 4,200 deaths annually, according to the National Cancer Institute.

Roche’s new product is the first, the company said, to test simultaneously for HPV 16 and 18, the two strains of the virus most likely to cause cervical cancer.

Roche’s HPV test is likely to compete with automated tests from Netherlands-based Qiagen NV and Massachusetts-based Hologic Inc., according to a report from MarketWatch, which estimated the automated HPV test market at $300 million in the United States. Automated tests are rarely used outside the United States, but Roche officials told MarketWatch they expect their test to gain traction.

The traditional smear tests for cervical cancer are still common around the world, but they require the analysis of doctors, which leads to errors. Roche’s clinical trials of its cobas HPV test found that one in 10 women received a false negative from smear tests. Roche's test confirmed that those women did, in fact, have cervical cancer.

“We look forward to working with laboratories and physicians to introduce the cobas HPV Test into routine cervical cancer screening,” Daniel O’Day, chief operating officer of Roche Diagnostics, said in a statement.