NEW YORK – With new agreements with Laboratory Corporation of America and Quest Diagnostics announced last week, Roche is ramping up commercialization of its sample self-collection devices for human papillomavirus testing.
The self-collection solution, which includes two devices, received approval from the US Food and Drug Administration in May for use with the firm's FDA-approved Cobas HPV test. The molecular test runs on the company's Cobas 4800, 5800, and 6800/8800 systems and first received FDA approval in 2011. The test detects the presence of the DNA of HPV genotypes 16 and 18, which are responsible for the majority of cervical cancers, and reports the 12 other high-risk HPV types as a combined result from one sample.
The self-collection devices are intended for use in a clinical setting where a patient can collect their own vaginal swab sample with instructions provided by QR code or a guide from a healthcare professional, said Denise Heaney, chief medical partner for molecular solutions and infectious disease at Roche Diagnostics.
For sites offering self-collection, the devices can use a swab manufactured by Copan Diagnostics or the Evalyn brush manufactured by Rovers Medical Devices, depending on patient preference. There is no difference in performance using either or both, Heaney noted.
Once the collection is done, the sample is resuspended into the approved viral transport media and tested in the same way a traditionally collected cervical specimen would be. Regardless of how the specimen is collected, samples are processed on the Cobas system "exactly the same way with no differentiation," Heaney said.
However, she noted that healthcare-collected samples are cervical specimens collected in the same way as a Pap smear, while self-collected samples are vaginal specimens.
Roche's intent with the launch of its self-collection solution and its agreements with large reference laboratories like Labcorp and Quest is to "broaden access to care" and improve accessibility. Self-collection "allows us to … meet the patient where they are," she said.
Traditional collection can be difficult for patients for myriad reasons, including concerns around privacy and past trauma associated with sample collection, so "the goal here is to really be able to offer something that is acceptable to those that would not normally be screened or have been underscreened," Heaney said. However, she noted that self-collection isn't intended to replace traditional collection and the standard of care. The intent is to "increase the volume" of patients screened, "which means that ultimately we're improving screening overall."
Last year, the US Preventive Services Task Force released draft recommendations for cervical cancer screening that included patient-collected samples for high-risk HPV screening. The organization noted that there is "adequate evidence" that self-collected HPV screening has similar accuracy to clinician-collected HPV screening.
Jeffrey Klausner, a professor of clinical population and public health sciences at the University of Southern California's Keck School of Medicine, echoed Heaney's comments, saying that self-collection "makes it much easier for patients, increases privacy, and avoids the dreaded pelvic examination."
"The more we can give control to patients, the better," he added. "Patient control results in better screening and more adherence to screening."
Laboratories can also benefit from self-collection, he noted, because there will be an increase in testing demand and labs can offer their own screening programs.
Klausner has done projects across the globe to study self-collection, and "in every population we have studied … women always prefer to self-collect samples."
"We give patients choice, we give them control, we build trust and strengthen the patient-provider relationship," he added.
Large reference laboratories can offer Roche's self-collection solution in their patient service centers, and each center that adopts the solution can choose to offer either the brush or swab or both. In a statement, Quest Diagnostics said that providers in the US can order the self-collection solution for use in their offices or other healthcare settings and noted that the solution will be available at its patient service centers starting next month.
Labcorp also noted that the self-collection solution will be available by physician order and can be completed in a healthcare setting or at one of Labcorp's patient service centers.
While Heaney declined to comment on pricing for the solution, she said that the CPT code for HPV testing is the same regardless of how the specimen is collected and can be used for both vaginal and cervical samples. In addition, because HPV testing is preventive, most insurance plans cover it at no cost to the patient.
Roche is one of two firms with an FDA-approved self-collection solution for HPV testing — the other, Becton Dickinson, has also received Health Canada approval for self-collection. Last year, a five-year pilot study conducted by MD Anderson researchers and Texas-based federally qualified health center Su Clinica began to evaluate BD's self-collection solution in a clinical setting.
Heaney noted that Roche is exploring broader self-collection solutions for other diseases beyond HPV, including sexually transmitted infections.
Barbara Van Der Pol, director of the University of Alabama at Birmingham STD Diagnostics Laboratory, said via email that expanding self-collection in clinical settings to at-home collection for samples to be sent to laboratories is the "next step in the process of expanding access to both HPV and other STI screening services."