The only Food and Drug Administration (FDA) approved cervical cancer screening test that allows HPV 16 and 18 genotyping concurrently with high-risk HPV testing is now cleared for usage. These genotypes are responsible for 70% of all cervical cancer cases. The cobas HPV (Human Papillomavirus) Test identifies women at highest risk for developing cervical cancer. This test will help physicians make early, more accurate decisions about patient care, which may prevent many women from developing this deadly disease.

Persistent infection with Human Papillomavirus is the principal cause of cervical cancer in women, with HPV implicated in greater than 99% of cervical cancers worldwide. According to the National Cancer Institute, there are 12,200 new cases of cervical cancer in the United States annually and 4,210 deaths due to the disease. The World Health Organization estimates there are 470,000 new cases of cervical cancer annually.

Daniel O’Day, Chief Operating Officer of Roche Diagnostics stated:

“The FDA approval of the cobas HPV Test demonstrates the value of simultaneous HPV 16 and 18 genotyping in cervical cancer screening. We look forward to working with laboratories and physicians to introduce the cobas HPV Test into routine cervical cancer screening.”

The cobas System is designed to deliver new standards in laboratory testing efficiency and medically relevant diagnostic information. The system offers true walk-away automation and can run up to 282 tests in less than 12 hours, providing rapid analysis of screening tests for HPV infections meeting the needs of the majority of clinical labs.

Mark H. Stoler, MD, Professor and Associate Director of Surgical Pathology and Cytopathology, at the University of Virginia Health System continues:

“Screening for high-risk HPV genotypes provides important additive information to Pap testing, and screening for the two highest risk types, HPV 16 and 18 can provide predictive information about a woman’s risk for having cervical pre-cancer or cancer. The cobas HPV Test provides physicians with a validated tool that helps them make early and more informed decisions regarding patient care.”

Actual cervical cancer is rare in the U.S. because most women get Pap tests and have abnormal cells removed before they turn into cancer. When infection with high-risk HPV types occurs, there usually are no symptoms.

Often, the first clue is a Pap test result that is abnormal. In a Pap test, the doctor takes a swab of cervical cells and has them analyzed in a laboratory. If the Pap test results are unclear, the doctor may order a HPV test to check the DNA type of the virus. This analysis can identify 13 of the high-risk HPV types associated with cervical cancer. It does not identify cancer. But it tells the woman and her doctor if she has a type of HPV capable of causing cancer.

There’s only one sure way to eliminate any chance of HPV infection: Avoid all genital contact with another person. To reduce risk, it’s best to have a mutually monogamous sexual relationship with an uninfected partner. However, many people don’t know if they’re infected. Using condoms can help prevent HPV transmission but are not foolproof. The virus can be transmitted to genital areas not covered by the condom.

Sources: The American Social Health Association and Roche

Written by Sy Kraft