Cervical Cancer ScreeningMost cases of cervical cancer can be prevented through early detection and treatment. In 2014, the FDA approved the Roche Cobas HPV test as a primary screening tool for cervical cancer, which means it could be used before a Pap test. This is a real-time PCR-based test from Roche Diagnostics with 16 primers that targets a region on the L1 gene of the Human Papilloma Virus (HPV).Along with diagnosing cervical cancer, the test also can provide information about the patient’s risk for developing cervical cancer in the future. While the traditional Pap tests finds changes in the cells of the cervix (the mouth of the womb) that are not normal, HPV tests can find any of the high-risk types of HPV that are most commonly found in cervical cancer. The test detects DNA from 14 high-risk HPV types, including types 16 and 18, which are responsible for 70 percent of cervical cancers.

Two leading medical societies- the American Society for Colposcopy and Cervical Pathology (ASCCP), and the Society of Gynecologic Oncology (SGO)- issued an interim guidance report supporting HPV in January 2015. The report suggests HPV testing as an effective alternative for screening with either cytology (the Pap test) alone or co-testing with cytology and HPV testing. Published online in the January 7 issue of Gynecologic Oncology, the guidance report targets clinicians considering primary HPV testing for cervical cancer screening and describes the potential benefits and disadvantages of this method.

A recently published AACC article effectively summarizes these medical societies’ recommendations for physicians

  • Considering HPVpr testing for women starting at age 25
  • Those with negative results should be retested only after three years
  • Women who test positive for HPV 16 and 18 should have colposcopy
  • Those testing positive for the 12 other high-risk HPV genotypes should have reflex cytology

The authors of the interim guidance also note that one of the main benefits of HPV over cytology testing is that it is a single FDA-approved algorithm for handling abnormal results. Moreover, they point out that the test that offers better sensitivity and negative-predictive value (NPV) for cervical intraepithelial neoplasia grade 3 (CIN3) or higher as indicated by the final data from the Addressing the Need for Advanced HPV Diagnostics (ATHENA) trial).

The AACC article quotes an expert as saying that laboratorians will have an important role in helping clinicians sort out the various recommendations. With the changes taking place in the HPV testing scenario, one expert points out that “laboratorians and clinicians should prepare for a future in which they will do more HPVpr tests and follow- up of HPV 16/18 positive results.”