News on Wellness

FDA Approves New HPV Test – Alternative to Pap Smear


Doctors strongly advise women to be their own warriors and to get a yearly pap smear, as this is the most effective way to battle cervical cancer. However, now we got alternative to pap smear, a new test approved by the FDA, called the cobas HPV Test.
Cervical cancer is caused by human papillomavirus (HPV), which is a sexually transmitted virus. The subtype HPV16 is known to play a vital role in the development of the cancer, which is one of the most common cancers in women of child-bearing age.

Using a sample of cervical cells, the cobas HPV Test detects DNA for “high-risk” HPV types that are associated with cervical cancer.

“Today’s approval offers women and physicians a new option for cervical cancer screening,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer,” according to the FDA News Release

For decades, the Pap test was the only screening option for cervical cance. HPV test costs generally cost between $80 and $100, about twice as much as a $40 Pap.

The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year and that over half of all sexually active men and women become infected at some time in their lives. An estimated 20 million people are currently infected with HPV. Approximately 14 “high-risk” types are associated with cervical cancer.

The American Cancer Society estimated about 12,360 cases of invasive cervical cancer would be diagnosed in the United States in 2014 and about 4,020 women will die from cervical cancer in the United States.

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