HPV Test Approved for Use with SurePath Preservative Fluid

Human papilloma virus (HPV) infections are the most common sexually transmitted infections in the USA, and HPV genotypes 16 and 18 cause approximately 70 % of cervical cancers worldwide. According to the National Cancer Institute, there will be an estimated 12,990 new cases and 4,120 deaths from cervical cancer in the USA during 2016.

Prior to the approval, some laboratories used cervical cell samples collected in SurePath Preservative Fluid to run HPV tests, in lieu of collecting an additional sample in a separate collection fluid that had been approved for use with those tests. Patients who receive false negative HPV test results may not receive appropriate follow-up care, which could lead to cervical cancer progression.

The US Food and Drug Administration (FDA, Silver Springs, MD, USA) approve HPV tests to be used with specific collection fluid, which store and preserve cervical cell samples for testing in the laboratory. The FDA based its approval of the Roche cobas HPV Test (Roche Molecular Systems, Basel, Switzerland) with SurePath Preservative Fluid (Becton Dickinson and Company, Franklin Lakes, NJ, USA) on a clinical study of 952 eligible women 21 years and older with abnormal Papanicolaou (Pap)test results.

The Roche cobas HPV Test with SurePath Preservative Fluid demonstrated similar clinical performance when compared to a previously approved cervical sample type. Of the samples that tested positive for HPV using the Roche cobas HPV Test with SurePath, 95.4% obtained the same result as the reference sample. Of the samples that tested negative for HPV using the Roche cobas HPV Test with SurePath, 93.2% obtained the same result as the reference sample.

The Roche cobas HPV Test with SurePath Preservative Fluid is approved for use with cervical cell samples obtained for a Pap test to screen women age 30 and older for HPV in order to determine whether additional follow-up and diagnostic procedures are needed. The FDA also approved the Roche cobas HPV Test with SurePath in women age 21 and older who have already had an abnormal Pap test result (borderline cellular cytology) in order to determine whether additional follow-up and diagnostic procedures are needed.

The test with SurePath is also able to detect high-risk HPV genotypes 16 and 18 in the same populations of women. The Roche cobas HPV Test with SurePath is not approved as a first-line primary HPV screening test. In addition, health care professionals should use the cobas HPV Test results together with other information, such as the patient screening history and risk factors.

Related Links:
US Food and Drug Administration
Roche Molecular Systems
Becton Dickinson and Company