Study Concludes Self-Sampling Using Colli-Pee® Device for HPV Screening Is Both Cost Effective and Could Improve Patient Access

BETHLEHEM, Pa., June 13, 2023 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and at-home diagnostic testing, as well as non-invasive self-sampling technologies and microbiome-focused biocomputational solutions, announced today that a major health economics study featuring its Colli-Pee^® device has been published in the biomedical journal “BMJ Open.” This study, conducted by experts from Aquarius Population Health Limited in London and the University of Manchester, presents valuable insights into the cost-effectiveness of self-sampling for routine human papillomavirus (HPV) primary cervical cancer screening using the Colli-Pee^® UCM^® self-collection device.

The study's noteworthy findings suggest that self-sampling with the Colli-Pee^® device could offer a more affordable alternative to clinician-collected sampling and other self-sampling methods. This has the potential to significantly expand access to cervical cancer screening for underserved and rural populations on a larger scale.

The health-economic research employed an innovative cost-benefit analysis model, utilizing real-world evidence from England’s primary HPV NHS Cervical Screening Programme (NHSCSP). The study compared three sampling approaches using a deterministic decision-tree model. The biocomputational analysis simulated a cohort of 10,000 individuals representative of the 400,000 people with a cervix aged 25 to 64 in England’s NHSCSP during 2020 and 2021. The three sampling strategies evaluated were routine clinician-collected cervical sample (identified as the most expensive option), self-collected first-void urine via the Colli-Pee^® device (the least expensive option), and self-collected vaginal swab (the second-most expensive). The Colli-Pee^® first-void urine collection device evaluated in the study is manufactured by OraSure's Belgium-based subsidiary, Novosanis.

“OraSure is committed to delivering user-friendly tests and collection devices that can be conveniently used in decentralized settings. The Colli-Pee^® collection device has the potential to reduce cost to the healthcare system, expand access to screening, and eliminate an invasive, sometimes painful, procedure for women,” said Carrie Eglinton Manner, President and Chief Executive Officer of OraSure. “We are excited about the potential of the Colli-Pee^® UCM^® device in improving access to cost-effective HPV screening and enhancing the patient experience worldwide and are actively engaged in multiple clinical research and commercial collaborations to establish first-void urine as a validated sample type for HPV screening, women's health therapeutics, and the detection of innovative oncology-related biomarkers,” she said.

According to the World Health Organization, HPV is responsible for over 99 percent of cervical cancer cases. The National Cancer Institute reports that half of new HPV cases occur among unscreened women. The UK-based study found that, if self-screening led to a 15 percent increase in women accessing the HPV cervical cancer screening program in England, along with an additional 50 percent transition to self-screening by women currently undergoing screening in physician practices, the NHSCSP could potentially save £19.2 million per year through minimally invasive first-void urine self-screening or £16.5 million per year through more invasive vaginal swab-based self-screening. These figures highlight the significant economic benefits associated with implementing self-sampling methods.

Overall, this pioneering study underscores the potential of self-sampling with the Colli-Pee^® device as a cost-effective solution for HPV cervical cancer screening. With its substantial impact on improving access to screening and reducing healthcare costs, it holds great promise in advancing women's health globally.

Full study results can be viewed at https://bmjopen.bmj.com/content/13/6/e068940.

About OraSure Technologies
OraSure Technologies, Inc., empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

About Novosanis
Novosanis NV, a subsidiary of OraSure, is an innovator of first-void urine (FVU) urine sample collection with the Colli-Pee^® sample collection device family to improve the quality of diagnostic tests for infectious diseases and oncology. The Colli-Pee^® devices provide non-invasive, self-collected, and volumetric sampling to standardize FVU collection, with a unique design to enable the immediate mixing of urine and preservative for FVU sample stability. Offering various sizes to capture a range of urine volumes for different application purposes, Novosanis is pioneering FVU sample collection as an alternative to invasive sampling demonstrated by strong clinical research outcomes, patient preference and affordability.

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