SUMMARY:

The FDA has approved expansions to the indications for use of two HPV tests currently on the market for cervical cancer screening. This FDA approval allows individuals to collect their own vaginal samples for HPV testing with the caveat that self-collection should only take place in a healthcare setting when the patient and healthcare professional have determined that it is not possible for the clinical to collect the cervical specimen. Based on submitted data, the FDA considers the performance (e.g., Positive Percent Agreement [PPA]) of self-collection to be lower compared to clinician-collection.

Indication for Use

• The FDA had previously approved the following for cervical cancer screening through the detection of Human Papillomavirus (HPV) in cervical specimens collected in a health care setting by a clinician
  • Beckon, Dickinson (BD) and Co. Onclarity HPV Assay
  • Roche Molecular Systems, Inc. cobas HPV Test
  • Abbott simpli-COLLECT HPV Collection Kit
• The expansion to the indication for use (IFU)
  • Indication expansion includes self-collected vaginal swab specimen in healthcare settings

Self-collected vaginal specimens, obtained in a healthcare setting, can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical specimens otherwise cannot be obtained

General Device Description

• Onclarity HPV Assay (Becton, Dickinson and Company)
  • Endocervical brush/spatula combination or broom
  • Placed in a BD SurePath vial or placed in ThinPrep Pap Test PreservCyt Solution
  • Specifically identifies types 16, 18, 31, 45, 51, and 52 while reporting the other HR HPV types in groups (33/58, 35/39/68, and 56/59/66)
• cobas HPV Test (Roche Molecular Systems)
  • Endocervical brush/spatula or broom
  • Placed in the ThinPrep Pap Test PreservCyt Solution or using a cervical broom and placed in SurePath Preservative Fluid
  • Detects high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68

Benefit-Risk Determination 

Benefits

• May improve screening coverage for
  • Unscreened and underscreened women
  • Individuals who have issues such as comorbidities who could not participate in clinician-collected cervical sample screening
  • Women who for various reasons decline or cannot undergo pelvic exams

Risks

• Risk determination based on FDA data review comparing clinician cervical collection vs vaginal self-collection
  • Submitted data demonstrated reduced performance for vaginal self-collection
• Risks of self-collected vaginal specimens include
  • Higher false positive rate (Onclarity)
  • Less sensitive and specific (cobas)
• Due to reduced performance vs clinician-collected cervical sampling

… the primary risk associated with self-collected vaginal specimens may arise if regularly-screened individuals electively switch from clinician-collected cervical specimens to self-collected vaginal specimens, which could result in potential missed cervical disease cases that could have otherwise been detected and prevented using the current standard of care (i.e., clinician-collected cervical specimens)

Risk Mitigation

• Intended use only as an alternative option only if cervical collection is not possible
  • Self-collection “may be considered as an alternative specimen type when clinician-collected cervical specimen cannot be obtained”
• Post-approval study requirement
  • Validate the performance of self-collected vaginal swab specimens (‘n’ of some submitted studies were small)
  • Post-approval study will be under the auspices of the National Cancer Institute SHIP Trial (Self-collection for HPV testing to Improve Cervical Cancer Prevention)
• It would assist clinicians if professional guideline recommendations included guidance related on counseling patients regarding the above benefits/risks of vaginal versus cervical screening

Learn More – Primary Sources

FDA Summary of Safety and Effectiveness Data (SSED): BD Onclarity HPV Assay

FDA Summary of Safety and Effectiveness Data (SSED): cobas HPV test

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