Introduction

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The Ellele Sampling Device is UKCA and CE marked.

It consists of a moulded plastic introducer and an inflatable nitrile membrane operated by a syringe, providing a more comfortable alternative for collecting a rich sample representative of the entire vaginal environment.

Reimagining vaginal sampling

Conventional vaginal brushes and swabs were designed primarily for localised sampling, and as a result generate limited and highly variable samples. Moreover, reliance on speculum-based sampling introduces discomfort, anxiety, and pain, contributing to reduced uptake and delayed diagnosis [1]. While the diagnostic biochemical assays have advanced significantly, the tools used for sampling in clinical practice have evolved only incrementally [2].

At Ellele Health, we have reimagined vaginal sampling. By recognising both the diagnostic potential of vaginal samples and the limitations of existing collection methods, we developed patented, minimally invasive Ellele Sampling Device [3]. Purposefully designed for comfort and performance, the device features:

  • a comfort-optimised introducer and
  • a large-surface sampling membrane,

This enables gentler collection of richer, more representative samples than conventional approaches.

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Our design capitalises on growing evidence that exfoliated cells and cell-free DNA originating from the upper reproductive tract can be reliably detected in vaginal secretions, alongside the full complement of cervicovaginal mucus and fluid components [4,5]. Therefore, the Ellele Sampling Device enables cutting-edge multiomics analysis on the sample representative of the entire reproductive tract, while prioritising patient comfort and dignity.

Benefits of the Ellele Sampling Device

SAMPLES

Superior sample collection

  • The Ellele Sampling Device is designed to be inflated only upon insertion, reducing chances of contamination. The ~84 cm2 of nitrile membrane has ~20x more surface area than a swab, enables adsorption and release of enough sample to support multiple downstream assays from a single sample.

Richer, more comprehensive sample

  • Both host and microbial cells are collected, with up to 66 µg of high-quality DNA (>90% with DIN > 8) extracted per sample, ~ 26x more DNA than from a swab [6]. Broader characterisation of sample analytes, including cells, proteins, and metabolites is in progress.

Extensive diagnostic and research assay compatibility

  • Compatible with a range of buffers, our sample has been validated against diagnostic (HPV) and research assays (microbiome sequencing, methylation and mutation analysis). Validation across modalities from a single sample is in progress.
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PATIENTS

Strong preference over speculum-based exams

  • In our feasibility study, 100% of participants expressed a preference for the Ellele Sampling Device compared with a traditional speculum examination.

Significantly improved comfort

  • ~80% of participants reported markedly greater comfort or reduced pain when using the Ellele Sampling Device versus a speculum-based exam.

Improved patient experience supports better clinical outcomes

  • Reduced anxiety increased willingness to attend appointments, enabling earlier diagnosis and improving the likelihood of timely treatment.
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CLINICIANS

Consistent, high-quality sampling

  • Unlike brushes and swabs, sampling with Ellele Device is independent from operator skill or sampling location ensuring consistency and minimal risk of contamination.

Used by any HCP

  • The device can be used by any trained HCP, enabling broader adoption and streamlined clinical workflows. In addition to ease of use, clinicians preferred the Ellele Device over speculum in 95% of examinations due to patient preference.

Improved diagnostic pathways

  • By enabling high-quality sampling in primary care settings, the Ellele Sampling Device can replace invasive specialist-led procedures, improving access to diagnostics and supporting earlier intervention.
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How it works

References

  1. O’Laughlin, D. J., et al. (2021). Addressing anxiety and fear during the female pelvic examination. Journal of Primary Care & Community Health, 12.
  2. Kaplish, L. (2023). A nasty history of the vaginal speculum. Wellcome Collection. https://wellcomecollection.org/stories/a-nasty-history-of-the-vaginal-speculum
  3. Crespillo-Casado, A., et al. (2026). Feasibility and acceptability of the Ellele Sampling Device Kit for vaginal mucus collection suitable for molecular diagnostics [Manuscript submitted for publication].
  4. Erickson, B. K., et al. (2014). Detection of somatic TP53 mutations in tampons of patients with high-grade serous ovarian cancer. Obstetrics & Gynecology, 124(5), 881–885.
  5. Njoku, K., et al. (2024). Detection of endometrial cancer in cervico-vaginal fluid and blood plasma: Leveraging proteomics and machine learning for biomarker discovery. EBioMedicine, 102.
  6. Ellele data on file [indirect, literature-based comparison].