Mar 14 2009
FDA approves two new HPV tests
It is being reported that the U.S. Food and Drug Administration (FDA) has approved two new tests that can detect and differentiate between some strains of human papilloma virus (HPV), the culprit of most of the cervical cancers among women in the US.
Cervista HPV HR, the first DNA test approved by the FDA in 10 years. is designed to detect 14 different high-risk types of HPV that are known to cause cervical cancer. The other test, Cervista HPV 16/18 can differentiate between type 16 and 18 of HPV, which are responsible for nearly 70% of all cervical cancers in the US.
FDA approved the tests after the two tests performed well in a large clinical trial involving more than 4,000 women from 89 different US cities. The Cervista HPV tests were developed by Hologic, a leading developer, manufacturer and supplier of medical equipments and surgical products, based in Bedford, MA. The company claims that their new tests will provide significant advantages over the existing technology in detection of cervical cancer.
HPV infection is regarded as the most common sexually transmitted infection in the US. It mainly transmits through unprotected sexual activities and infects more than 6 million people annually. HPV infection is also a major cause of nearly all cases of cervical cancer. Now, these two tests are expected to help health care professionals in proper screening of HPV.
