DNA Test to Replace Pap Smear

DNAThe Pap smear or Papinicolou Cervical Cancer Test is designed to detect early cancer of the cervix. It requires expert technique in obtaining the specimen during a speculum pelvic exam, expertise in applying the swab obtained specimen to a glass slide and preparation of the slide for transport to a cytology lab for microscopic evaluation. The microscopic evaluation is supposed to be performed by a specially trained and certified cytologist but they are in very short supply. The result is that there is great variability and suspected variation of accuracy in this test.

We now know that cervical cancer is a sexually transmitted disease (STD) of the human papilloma virus particularly HPV strains 16 or 18. Roche Molecular Systems has obtained FDA approval for its HPV DNA molecular test looking for fourteen high risk HPV strains. If a woman is found to have strain 16 or 18 health care professionals are advised to proceed to testing with colposcopy. If one of the other strains is found it is suggested that a Pap smear be performed to screen for the need for colposcopy. The FDA approval came after testing 48,000 women and comparing the accuracy of Pap Smears versus the DNA testing.

The new FDA approval allows clinicians to use the HPV testing alone or in conjunction with Pap smears.

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