Genetic Test as Option to Pap Smear Approved by FDA

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By Karla Danica Figuerres | April 29, 2014 4:41 PM EST

U.S. federal health regulators have cleared a genetic test from Roche as a standalone screening option for cervical cancer.

Initially, it was reserved only for pap smear. The Food and Drug Administration (FDA) accepted Roche's cobas HPV test to expose the human papillomavirus (HPV) in women aged 25 and up. HPV generates almost all cases of cervical cancer.

Doctors have used DNA-based tools as a follow-up to validate pap test results. But the approval means Roche can now advertise its HPV test as a first-choice option for cervical cancer screening, ahead of the pap test. Currently, no major medical guidelines suggest HPV testing solely for cervical cancer screening.

Dr. David Chelmow of Virginia Commonwealth University said physicians should delay using the test until medical community can give teachings on some primary questions.

Roche supported its proposal for expanded marketing with study results proposing genetic testing is more precise and fair at recognizing cancerous growths than the pap smear, which demands doctors to test cervical cells under a microscope for signs of cancer. The test recognizes 14 high-risk forms of HPV that can cause cervical cancer.

Many are against the approval of FDA on the DNA testing as an alternative to pap. They said it can only lead to confusion, expensive and overtreatment. Many patients raised their concerns in a letter to FDA in the previous week.

The letter was from Cancer Prevention and Treatment Fund, a research and patient education organization,  and signed by the American Public Health Association, Consumers Union and the National Organization for Women.

FDA representatives said they accepted the test because "Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness."

The test consisted over 47,000 women who have undergone screening using either pap or HPV screening. The test results were then reviewed for certainty whether they have cancer.

Pap test was the only screening option for cervical cancer for decades and it had a favorable track record. The number of cervical cases in U.S decreased more than 50 percent in the past 30 years, mainly because of increased pap screening. HPV test may possibly cost between $80 and $100, about twice as a $40 pap.

Under the latest guidelines from the American Cancer Society, a pap test is advised every 3 years for women aged 21 to 29. Women 30 and older should have both a pap test and an HPV test every 5 years, or a pap test alone every 3 years.

Meanwhile, Roche is admitted to advertise its test for women as young as 25.

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