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New Cervical Cancer Screening Tests Rival the Pap Smear
FDA recently expanded approval of two HPV tests to allow self-collection of samples in a clinical setting. At-home testing may not be far behind.
4 Min Read
BD/Becton, Dickinson and Company
At a Glance
- FDA has approved two tests to allow women to collect a vaginal sample themselves in a healthcare setting.
- Copan's swab or Rovers' brush are the key devices in test kits sent to labs for testing.
- Last-mile clinical trials are underway to assess the efficacy of at-home self-collection.
Pelvic exams that include testing for human papillomavirus (HPV), the cause of almost all cervical cancer, can be a source of discomfort and anxiety for many women. But a recent US Food and Drug Administration (FDA) approval that gives women the option to collect a vaginal sample themselves in a healthcare setting promises to change that.
The two tests covered by FDA’s HPV self-sampling approvals are Becton, Dickinson and Company’s (BD) Onclarity HPV and Roche’s cobas HPV. Copan Diagnostics’ FloqSwab is one of the devices approved for self-collection in both of these diagnostic tests. Rovers Medical Devices’ Evalyn brush has also been approved for use in Roche’s cobas HPV test.
Two sample collection devices are approved.
Packaging Digest reached out to Copan Diagnostics and Rovers Medical Devices to find out more about these self-collection devices as well as packaging’s role in protecting the test sample and ensuring that women take accurate samples. Here’s what we learned:
Copan Diagnostics’ FloqSwab: These flocked swabs, used in Roche’s and BD’s tests (the latter shown below), are used in a range of clinical and laboratory applications. Each swab is individually packaged in a dry plastic tube to ensure the safe transport of samples from the collection point to the testing site.
According to a Copan Diagnostics spokesperson, the instructions for use (IFUs) are critical to ensure correct and effective self-collection: “The IFUs clearly explain how to open the swab by twisting the cap and how to handle the swap by gripping [a] marked red line on the shaft, which indicates both the correct grip point and the insertion depth within the vaginal canal.”
A lightweight, compact protective sleeve maintains the swab’s integrity both before and after use. Diagnostic assay manufacturers that source swabs from Copan work with clinical sites to determine the final packaging configuration of the self-collection kit provided to the patient. The swab preserves DNA stability up to four weeks at room temperature.
“Self-collection using swabs in the US is becoming an increasingly popular method for testing various pathogens,” the Copan spokesperson added. “This approach offers several benefits, including improved access to testing, reduced healthcare costs, and enhanced patient comfort and privacy.”
Rovers’ Evalyn brush: Roche uses this device in its cobas HPV test as an alternate to the FloqSwab. Unlike FloqSwab, which can be used for a range of applications, it’s designed specifically for self-collection for HPV testing. The device, which also serves as the container for the Evalyn brush, sports a bright pink cap that marks the insertion point and is removed prior to use. In addition to this visual aid, the device uses tactile and auditory cues to support consistent outcomes.
Evalyn self-sample collection brush and device in blister pack. Image: Rovers
“We came up with a fixed insertion length so women will know when it is correct and so that it reaches relevant areas in the vagina to ensure a good sample,” explains Randolf ten Cate, business development manager at Rovers Medical Devices. “When the brush is in position, the user hears a click, which adds to the quality of the sample further down the line, because if your sample is bad, then your test is bad.”
Once the brush is positioned, the user pushes the plunger and rotates it five times, listening for an audible click with each rotation to confirm that the test has been done correctly. After removing the device, the woman replaces the cap and returns the device to the blister pack for in-clinic collection.
The Evalyn brush is packaged in a transparent polyethylene terephthalate (PET) blister sealed with two-color printed medical paper and sterilized with ethylene oxide (EtO). The device containing the brush is made from polyethylene (PE) and polypropylene (PP).
Test kits vary by brand, language and add-ins to suit requirements by region/country. (Image: Rovers)
Last-mile trials are underway for at-home testing.
The Evalyn brush has been approved for at-home use in other countries, which calls for additional packaging. Self-collection kits that arrive in the mail are typically packaged in a foldable sleeve with divisions to accommodate the introduction brochure, the IFU, the Evalyn brush, and a UN3373 specimen bag for returns. Depending on the country, kits can also be returned to a drop box at a local medical center where they are picked up by a courier and delivered to a lab for testing.
Rovers manufactures the Evalyn brush and its primary blister package. The company also produces paperboard boxes for use in at-home collection kits. The brush ensures the stability of DNA samples up to 104 degrees Fahrenheit for several weeks according to ten Cate.
Both Roche and Becton Dickinson’s HPV DNA tests are part of a clinical trial led by the National Cancer Institute to assess the safety and efficacy of home self-collection for cervical cancer prevention. Copan anticipates that the future of self-collection will shift to at-home settings where it could have a significant, positive healthcare impact.
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