by Dr. Jeff Andrews is Vice President, Medical Affairs at Waters Advanced Diagnostics
Almost all cervical cancer cases are caused by persistent high-risk human papillomavirus (HPV)1, which causes thousands of deaths each year in the U.S.2 Today, we know that these deaths are preventable with HPV vaccination and early detection screening.3
Earlier this year, the U.S. celebrated an important milestone for cervical cancer prevention with FDA clearance of the Onclarity Self-Collection Kit for at-home use4, meaning women and people with a cervix can collect a sample in the comfort of their home without having to test in a clinical setting (in cases where a cervical sample is contraindicated or otherwise cannot be obtained).
The significance of this breakthrough goes far beyond the technology itself; it signifies the opportunity to break down longstanding access barriers at a time when 60% of cervical cancer cases occur among individuals who are unscreened or underscreened.5 There are a multitude of reasons patients go under- and un-screened. Although 62% of women say they understand that cervical cancer is preventable with regular screenings, more women (72%) report having delayed a gynecology visit.6 More than half of women (54%) say they delayed their visit due to fear or discomfort, and 49% cited scheduling-related challenges. There are also prominent screening gaps among underserved populations with historically low access to healthcare, including people with lower income, rural communities and certain racial and ethnic groups.7 At-home HPV self-collection has the potential to bridge these gaps by removing the physical, logistical and emotional barriers associated with in-clinic visits.
As this promising new testing method expands, it is equally important to understand the role laboratories will play in making it successful. The true impact of at-home HPV self-collection depends on the journey that will carry each sample from the patient’s home, through the laboratory, to a result that will allow physicians to take the best actions.
Where it starts
The at-home screening process starts before a patient receives a self-collection kit. The process begins with an in-person or virtual interaction with a clinician and a lab order. From here a kit is mailed directly to the patient’s home, allowing them to self-collect a sample comfortably without the stirrups or speculum. The collection itself is designed to be simple, minimally invasive and often takes less than a minute.8
From there, patients can mail the sample directly to a laboratory for processing. The costs associated with the kit and shipping are incorporated into the existing reimbursement for HPV testing, meaning laboratories must account for these costs within the current reimbursement structure.9 The updated Health Resources and Services Administration (HRSA) guidelines, which emphasize zero out-of-pocket coverage for preventive services, will go into effect January 2027, which will ultimately expand coverage and access even further.10
This is where the operational focus shifts to maintaining the stability of the sample as it makes its way to the laboratory. Extensive research has been done over the years to ensure the stability of a sample between at-home collection and when it reaches the lab. In the U.S., FDA approval allows for 14 days of transit time and up to 30 days prior to testing from the time of sample collection.11
Packaging is also heavily accounted for. Kits are made to be shipped and delivered in the smallest possible boxes, to reduce weight and volume to keep shipping prices at a low cost. The packaging is also designed to maintain sample integrity throughout the shipping process. For the return trip, the sample collection swab remains in its tube, which is placed in a sealable specimen bag and then returned in the provided packaging, creating three layers of protection for the biological sample.
For laboratories and healthcare systems designing these programs, these seemingly mundane logistics are now important factors of a successful program. It is essential to make sure that sample integrity is maintained all the way from a patient’s home to the laboratory.
Arrival at the laboratory
Once the sample reaches the laboratory, the focus is now on how efficiently it can be incorporated into existing workflows.
In an industry already facing workforce constraints, this matters. Vacancy rates remain above pre-pandemic levels in medical laboratories, alongside continued challenges recruiting and retaining qualified professionals.12
In the hope that at-home HPV self-collection succeeds in reaching more unscreened and under screened patients, laboratories should expect greater testing volume. The goal should be to absorb that volume without requiring manual work to grow at the same rate.
Efficiency is key for supporting an increase in samples. There are end-to-end automation options created for this purpose. The BD CORTM System is designed to reduce laboratory hands-on time by up to 50%13 and features approximately 50% smaller instrument footprint13, compared with other high-throughput molecular systems.Those kinds of efficiencies may help laboratories increase throughput without expanding staffing and laboratory space.
There is a financial case for that approach as well. Automation requires investment, but studies of clinical laboratories have found that reducing repetitive specimen-handling steps can improve productivity and lower labor-related operating costs. One study of a large U.S. core laboratory, for example, found that total laboratory automation eliminated 22 hours of hands-on work per day, representing approximately $230,000 in annual labor-equivalent savings.14
Designing the workflow for at-home self-collection
The design of the collection method can determine what happens next. With the Onclarity Self-Collection Kit, at-home HPV self-collection uses a dry swab that is placed in a sample tube which is sent to the laboratory. With an automated workflow, that tube can then be loaded onto an automation rack without laboratory staff having to manually transfer the swab or aliquot the sample first. Fewer manual interventions can mean less hands-on time, fewer repetitive tasks for laboratory professionals and greater capacity to process additional samples.
The ability to anticipate where additional labor, time and resources may be required will distinguish laboratories that are prepared to scale from those forced to adapt after demand arrives.
The role of extended genotyping
Laboratories should also consider what is reported to clinicians from a sample. Extended HPV genotyping provides more specific information about a patient's risk than a pooled high-risk HPV result. The BD OnclarityTM HPV Assay, for example, identifies six individual HPV genotypes and three strategically pooled genotype groups covering all 14 high-risk, carcinogenic HPV types.11
The laboratory's operational responsibility then becomes accurately identifying and reporting those specific results to the ordering clinician, who will determine next steps for patients. Distinction and precision are important as different genotype results can lead to different clinical pathways under current ASCCP guidance.15
If certain HPV genotypes are detected, patients will be required to return to a clinical setting for cytology or other follow-up procedures, generating additional specimens that need to be processed by the laboratory. Extended genotyping can also negate unnecessary procedures, with the detection of lower-risk individuals who test positive for HPV 56/59/66.15
Last thoughts
Greater access to testing has the potential to bring millions of unscreened and under screened patients back into the screening system, in turn this also means millions of new samples being sent to the laboratory. Delivering on that opportunity requires laboratories that are ready to act on this exciting influx.
The entire end-to-end journey needs to be evaluated and accounted for. From where delivery starts, how samples are collected, processed, and results are reported. Laboratories that build scalable, end-to-end workflows today will be better prepared for expanded screening tomorrow.
About the author
Dr. Jeff Andrews is Vice President, Medical Affairs at Waters Advanced Diagnostics. He is a practicing obstetrician-gynecologist who has performed cervical cancer screenings for decades.