FDA Approves 2 New HPV Tests From Hologic

WASHINGTON (AP) — The Food and Drug Administration has approved the first genetic test that differentiates between the two types of human papillomavirus that cause the majority of cervical cancers.

Shares of manufacturer Hologic Inc., whose products are geared toward women's health, soared in trading Friday afternoon.

The company's Cervista diagnostic test differentiates between type 16 and 18 HPV, giving doctor's more information about a patient's risk of developing cervical cancer.

The FDA also approved a second DNA test from Hologic that detects the 14 types of HPV that pose a high risk of causing cancer.

In women 30 and older, the two tests can be used together to get a comprehensive risk assessment of cervical disease, the FDA said.

According to the Centers for Disease Control and Prevention, an estimated 6 million Americans are infected each year with HPV, the most common sexually transmitted disease in the U.S.

Hologic is expected to take market share away from diagnostic maker Qiagen NV, which sells about $250 million in HPV-related products annually, according David Lewis, a medical technology analyst with Morgan Stanley.

Shares of Hologic rose $1.20, or 11.3 percent, to $11.78 in afternoon trading, while shares of Dutch diagnostic company Qiagen NV fell $1.19, or 7.4 percent, to $15.