Focus On: HPV Testing
It was the sound-bite heard 'round the world: "This particular cancer is caused by HPV, which . comes from [oral sex]," said cancer survivor/actor Michael Douglas. In a June interview with UK's The Guardian, Douglas said that the walnut-sized tumor in his throat may have been derived from human papillomavirus (HPV), a sexually-transmitted infection already implicated as a precursor to cervical cancer.
The statement was trumpeted in U.S. news broadcasts and was top-of-the-page fodder for all manner of websites. While a degree of prurient interest may have sparked such widespread circulation, the value of the publicity should not be lost on the healthcare community. John and Jane Q. Public have just gotten a celebrity-driven wake-up call about the significance of HPV and the need to test for high risk varieties.
Clearly, HPV is not a risk factor for women only. The CDC confirms that about 6,700 men are diagnosed annually with oropharyngeal cancer associated with HPV. "The HPV type and the persistence of an HPV infection is perhaps the most important determinants of progression" of related cancers, according to ACOG Practice bulletin 109.
Vanessa Cullins, MD, vice president for external medical affairs at Planned Parenthood Federation of America, told ADVANCE, "People are now recognizing that HPV plays an important role in other cancers - vulvar, vaginal, penile, anal, throat, head and neck. A great deal of research is being done on the utility of an anal cellular smear - something parallel to a Pap smear - to screen for anal cancer. But research does not yet give conclusive guidance as to when and how often an anal smear should be done, and who should routinely have one. There is still more to be learned."
Cervical cancer screening among women also has evolved as 2012 testing guidelines from the U.S. Preventive Services Task Force recommended that molecular HPV tests be done in concert with Pap smears for women between the ages of 30 and 65, every 5 years. In addition, the American Society for Clinical Pathology, the American Cancer Society and the American Society for Colposcopy and Cervical Pathology called for immediate HPV genotype-specific testing for HPV types 16 or 16/18 (which cause about 70 percent of all cervical cancers) as a patient option for women who are cytology negative and high-risk HPV positive.
The impact of this multidisciplinary recommendation is of landmark significance to "the way clinicians manage cervical cancer screening and the way labs support clinicians in that area of patient management," noted Chris Norris, director of marketing, molecular diagnostics, Roche Diagnostics.
"In addition to the first-ever indication of the preference for co-testing, this is the first time these groups have had uniform guidelines. Now clinicians don't have to wonder whose guidelines to follow," he said.
"With these new clinical guidelines for cervical cancer screening issued last year, the demand for HPV co-testing has the potential to increase significantly," advised Alan Wright, MD, MPH, chief medical officer for Roche Diagnostics, via news release.
Qiagen, Roche, Gen-Probe and Hologic are all big players in the HPV market, with new players joining the roster every year. And each has a technology that seems to expand the capabilities of testing.
Rick Pesano, MD, PhD, medical director, infectious diseases and women's health, Quest Diagnostics, said this evolution of HPV testing "holds the potential to improve the quality of cervical cancer screening and detection for women." Noting that HPV analysis now also incorporates molecular technologies to identify disease risk at the level of messenger RNA, he said Quest recently formed a strategic alliance with Hologic because of its APTIMA mRNA HPV test which detects the messenger RNA of two HPV viral oncogenes, E6 and E7. "The expression of these oncogenes may be more predictive of cervical cancer risk than testing for HPV DNA," he explained.
In June, the FDA approved Roche's new workflow process for its cobas HPV Test, approved in 2011. The cobas HPV Test is now the first HPV test to receive FDA approval for loading a Pap sample vial directly onto an automated system and for the use of primary vial samples after cytology processing. This allows labs to load the same vial used for a ThinPrep Pap test directly onto Roche's cobas 4800 System for high-risk HPV and individual HPV 16 and 18 genotype testing.
The new process eliminates the need for laboratorians to pipette samples from the primary vials used for liquid-based cytology into a separate tube. Instead, they can load the same vial directly after cytology processing. The streamlined workflow can help labs reduce costs, improve turnaround time and free staff to spend time on other tasks.
BD Diagnostics is now conducting clinical trials for the BD Onclarity HPV Assay on the BD Viper LT system. According to Bonnie Rib, BD's vice president/general manager, BD Diagnostics-Women's Health and Cancer, this test has capabilities that will go beyond current HPV tests on the market that provide a pooled result and discrete genotyping information for Type 16, 18 and Type 18/45.
"BD Onclarity HPV assay provides additional reporting of six discrete HR HPV genotypes (16, 18, 45, 31, 51 and 52) with the remaining eight high-risk types in three groups (33, 58), (56, 59, 66) and (35, 39 and 68). High-risk and genotype assay results are obtained from the same sample with no additional processing steps required," said Rib. She also noted that recent studies have demonstrated Type 31 is also an important genotype for the risk of development of CIN2+ (severe dysplasia).
AutoGenomics also offers several HPV detection solutions. "Our most relevant, the INFINITI HPV-HR assay, individually identifies the 14 high-risk HPV types for up to six samples on a single microarray," explained Rajasri Chandra, product manager. "Automated on our multiplexing microarray INFINITI System platform, this test delivers type-specific prevalence information for each high-risk genotype without the added work necessary in classical methods." The product is available for research only; however, AutoGenomics will submit a pre-market approval (PMA) for the assay and has already submitted a pre-investigational device exemption to the FDA for a clinical trial to support the PMA.
Valerie Newitt is on staff at ADVANCE.
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