UniPap – Pap Test at the Next Level

UniPath offers a revolutionary screening method for cervical cancers.  While the Pap test alone has decreased the number of deaths from cervical cancer by over 70% over the past several decades, adding a screening test for the Human Papilloma Virus (HPV) to a Pap test provides pathologists and clinicians with the most complete method of detecting women at risk of developing or having cervical cancer.  We call this UniPap (also known as DNAwithPap, our name for this combined testing off one specimen.

The FDA has approved, for women over 30, the combined use of the Pap test along with high-risk HPV DNA test as a primary screening modality. The rationale is that most of the small number of cases of high-grade dysplasia and carcinoma missed by the Pap test will be detected by the HPV DNA test and vice versa. The power of this combined testing strategy in conjunction with the relatively slow evolution of cervical lesions is of sufficient power that women over the age of 30 with negative results for both tests can safely be re-screened every 3 years. In addition to FDA approval, the DNA plus Pap test has been endorsed by the American College of Obstetricians and Gynecologists. 

By adding the Digene HPV test to the Pap test in women 30 years or older, there is less than a 1/1,000 chance that the patient has an unidentified cervical dysplasia or carcinoma, considerably better than that of the Pap test alone. Women whose cytologic diagnosis is that of low grade/high grade dysplasia or carcinoma should immediately be referred to colposcopy, as should women with a cytologic diagnosis of ASCUS/ASCUS-H with positive HPV DNA results. Women with a negative cytologic diagnosis, but a positive HPV test, should have both tests repeated at 6-12 months. Women with a diagnosis of ASCUS, but a negative HPV test, should repeat cytology at 12-months. Although women over 30 years old with a negative Pap test and negative HPV test need only have these tests repeated every 3 years, it is important to emphasize to the patient the importance of routine annual check-ups as part of their health maintenance program.

Contact UniPath at 303-512-0888 if you have any questions about this revolution in the diagnosis of cervical disease.  Or, if you already work with us and want to start using this test, simply mark the DNAwithPap box on our requisition when you send your patients’ specimens.