The phrase ‘high performance test’ is used regularly when addressing the in vitro diagnostics of human papillomavirus (HPV). Traditional methods of pap smears, acetic acid tests and simple swabs have been outshined in recent HPV diagnostic developments.
A key pillar of the cervical cancer elimination strategy is to improve and increase screening coverage for HPV diagnosis. The global strategy has established three targets along the pathway to cervical cancer elimination, two of which are centred around high performance HPV tests.
By 2030, the aim is to have 70% of <35 year old women screened using a high performance test method, followed by 90% of women with pre-cancer treated and 90% of women with invasive cancers managed.
High performance testing for HPV is a fundamental aspect to these goals. The recent advancements in HPV diagnostics have improved the accuracy of test results which will transcend into more efficient screening overall.
Why is HPV diagnostics important?
Improving the way HPV is diagnosed will ultimately lead to the identification of more cases. The priority, however, is not to diagnose larger volumes however, HPV diagnostics have put high quality testing methods at the forefront.
Undisputedly, higher quality testing will help diagnose more patients, yet the purpose is to improve the integrity of the results of those testing. High performance testing will reduce the strain on the healthcare ecosystem in four different ways:
Those who receive a negative result, will have a more accurate negative result and can consequently wait longer for a second test with little to no risk to the patient.
Those who may have received an undetermined result on previous occasions, can receive and positive or negative test result with a high-performance HPV diagnostic method.
Those who receive a positive result, will have a more accurate positive result, quicker treatment program and with a ‘test of cure’ outlook can seek high-risk HPV test results.
Those who receive a positive result, will have a more accurate positive result and therefore receive treatment for pre-cancerous HPV earlier than they may have with a different testing method.
All of the above will allow healthcare service providers to prioritise their treatment and screening programs efficiently, reliably utilising higher quality test results to navigate the number of diagnosed cases and treatment requirements.
Higher-quality negative results and fewer undetermined results will both impact secondary screening. This should result in more people successfully progressing to their secondary testing phase later in life, and those who need to be diagnosed will receive a more accurate and timely diagnosis. Ultimately, this will ensure that 70% of women have their second screening by the age of 45.
High performance HPV testing advancements
The aim with HPV diagnostics is to reduce the barriers to screening to achieve the 70% screened target. With this comes three new innovations which can remove barriers that would have otherwise blocked screening services from the patient.
Three new methods for HPV diagnostics
Strain-Level Molecular Testing
It’s been noted that many HPV tests can be run on the same equipment as COVID-19 PCR tests and HIV tests. DNA sequencing is thought to perform a higher quality test for HPV than other traditional methods, such as cervical biopsy.
PCR tests have enhanced the capabilities of HPV screening, with rapid PCRs, real-time PCRs and next-generation sequencing integrations all feasible in 21st-century screenings.
Next-generation sequencing allows for the comprehensive analysis of the HPV genome. This kind of high throughput sequencing can improve our understanding of HPVs role in cervical cancer progression, particularly through the identification of the specific types and variant of HPV strains with high resolutions, rather than just the presence or absence of HPV.
Multiplex PCR technology can detect multiple HPV types in a single assay, meanwhile, rapid and real time PCRs have dramatically improved the time to see results.
The precise identification of HPV, along with the identification of the HPV strain and progression, can show insights into likelihood of cancerous results, bringing patients closer to the right treatment from the moment of HPV diagnosis rather than shortly after the initial positive result from primary testing. The latter is often the timeline seen with other screening methods.
HPV Self Sampling Kits
RDi are particularly focused on the HPV self-sampling methods, as many advancements allow for patients to collect her own sample in an environment that offers them the most comfort.
Whether that is at home, or another remote location, HPV self-sampling provides a solution whereby the individual oversees their own sample collection, which puts accessibility and convenience at the forefront of testing.
At RDi, we expect this to have a dramatic effect on screening uptake. Studies have shown that self-sampling is as effective as clinician-collected samples for HPV detection, investigated in 2018 and 2020 respectively, with multiple other research studies finding similar conclusions.
Digital Health Technologies
Both advancements also lead to digital technologies as innovation continues to drive the use of data, AI and telemedicine in the healthcare sector. PCRs are an example of more advanced, droplet digital PCRs which provide an absolute quantification of HPV DNA, with the separation of fragments in nanodroplets facilitating the amplification of fragmented human and viral DNA.
HPV self-sampling methods can also be integrated with digital health platforms, such as the post-issuance technology RDi offers to its clients. At present, we provide our customers with insights regarding output, post-market activity and laboratory reception. These digital insights allow our customers to make data-led decisions and assess the completion of HPV sample collection kits on an individual and entire geographical scale.
For screening programs in particular, this is an invaluable tool that allows complete traceability of the HPV diagnostic screening kit from the points of assembly, as well as its onward journey direct to the patient or client.
RDi provides a global footprint of kits, allowing public and private screenings to take control of their distribution lines. High performance test methods, partnered with powerful screening data, can provide screening operations and logistics with the intel they need to reach the <70% diagnosed target by 2030.
Further advancements in the sector have seen HPV self-sampling kits be integrated with patient-facing software, allowing users to manage, track and access their submitted samples and associated results. AI driven analysis and telehealth platforms, such as Teladoc, Doxy.me, and Sesame Care, are all advancements that play a smaller role in improving the performance of HPV testing. With benefits such as improved results interpretation, facilitating remote sample collection requests and streamlining further patient data.
HPV diagnostics and HPV self-screening test kits
At RDi, HPV self-sampling is high on our agenda, with many public and private healthcare clients working alongside RDi to assemble and distribute their HPV self-sampling kits.
Our standardised CE-certified and MHRA-registered HPV screening kits allow businesses to represent their brand during the HPV diagnostic revolution, a key time when our high-volume production capabilities are vital. Automation rules out any quality concerns of assembled standardised kits, meanwhile, compliant UN3373 sample transport packaging safeguards HPV samples on their onward journey to the lab.
The first of its kind, ‘off the shelf’ HPV self-sampling kit provides a variety of businesses with the capability to bring HPV diagnostics to market, as more and more patients look to source kits from private companies to access high performing tests and receive the highest quality of results.
Remaining competitive during a global scale screening requirement is simple with our HPV self-sampling kits and outsourced production lines. Simply harvest your patient data and contact RDi for the assembly and fulfilment of up to 150,000 HPV kits per day!
As leaders in healthcare innovation, we’re pleased to exhibit at the IPCV2024, a meeting that boasts promising updates on cutting-edge HPV research. Aligned by the common goal of eliminating HPV-associated diseases, primarily cervical cancer, and research the WHO targets by 2030, we’re excited to strengthen HPV diagnostic relationships across the sector. Visit us at Booth 19 in the Edinburgh International Conference Centre on 12 – 15 November 2024.