The US Food and Drug Administration (FDA) has recently approved Roche cobas® HPV test to be used in tandem with Surepath™ Preservative Fluid — one of the two approved liquid collection fluids commonly used for Pap tests — for the detection of human papilloma virus (HPV) in cervical cells. It is the first HPV test to be used with the collection fluid. The announcement was made recently, in a press release on FDA’s site.
Preservative fluids are used to store and preserve samples obtained from biopsy for testing in the laboratory. In the US, the SurePath™ vial and preservative fluid are routinely used to process a large number of cervical cancer screening samples. Healthcare providers have been using samples stored in preservative fluids, including SurePath™, for quite a while but the FDA, however, had not granted an official approval to one, until now.
“Healthcare providers have been using samples stored in the SurePath Preservative Fluid with HPV tests for some time now, but there have been concerns about false negative results,” said Alberto Gutierrez, PhD, Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Now healthcare providers have access to an FDA-approved test and the information they need to use it properly to ensure the most accurate results for their patients.”
The newly approved HPV test will be used to screen sexually active women aged 30 and above. The test is not the first-line primary HPV screening test though, it will be used in conjunction with other information such as patient history and risk factors. In women aged 30 and above, it will be used as a preliminary guide to determine whether additional diagnostic workups and follow-ups are needed. In addition, the test will also be used to detect HPV infection in women aged 21 and older with a history of abnormal HPV findings. The test serves as a pathway to determine future clinical course of action.
The Roche cobas HPV test can detect high-risk HPV genotypes 16 and 18 in women. It even minimizes the risks of false negative results, the incidence of which is high around the globe. Until the approval of cobas HPV test, a number of laboratories in the US have been running HPV tests on cervical cells samples collected in preservative fluid. The number of the cases reported to have false negative results was high. Such misleading results can diminish the possibility of accurate diagnosis, appropriate follow-up care and progression of cervical cancer. The manufacturers of preservative fluids, including SurePath, are aware of the incidences and have repeatedly warned the laboratories that using such samples could lead to false negative results and increase the risk and progression of infections and cancers.
Sexually transmitted infections (STIs) are remarkably common in the US. Of all the infections, HPV infections take the lead and account for approximately 70% of the cervical cancers in the world. Around 14 million new genital HPV infections are reported each year in the US. Data from National Cancer Institute reveal that approximately 12,990 new cases of cervical cancer will surface in 2016, out of which 4,120 deaths will occur. Certain HPV types, such as genotype 16 and 18, can lead to abnormal cell changes and cause various cancers, including cervical cancer. In fact, researchers believe that HPV viruses cause as many as 99% of all cervical cancers.
HPV are a group of more than 200 related viruses, out of which more than 40 can easily spread through physical and sexual contact. Most HPV infections are low-risk, occur without a symptom and recede within a year or two without progressing to cancer. According to the Centers for Disease Control and Prevention (CDC), more than 80% and 90% of sexually active men and women, respectively, will be infected with HPV virus at least once in their life. Infections with high-risk HPVs, however, almost always lead to the cancer of vulva, anus, penis and oropharynx.
Amid this scenario, the approval of Roche cobas HPV test by the FDA will be tremendously useful in screening women for probable cervical cancer. Beside breast cancer, cervical cancer is the leading killer in women, although the wide practice of screening tests, such as Pap smear test, has successfully lowered the incidence by one half. Cervical cancer mostly affects women aged 50 and above. It is most common in Hispanic women.
The approval of Roche cobas HPV test comes after a clinical study was performed on 952 women aged 21 years and older. All women had abnormal Pap smear test results. When compared with the reference standard, the cobas HPV test in SurePath preservative fluid, was able to replicate the results successfully in as many as 95.4% of the samples.
The Roche cobas HPV Test is a product of Roche Molecular Systems, Inc, a subsidiary of the Roche Group, based in Basel, Switzerland. SurePath Preservative Fluid is manufactured by Becton Dickinson and Company, New Jersey.