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    Guidance assessment consultation document for HTG10877 Technologies for diagnosing endometriosis in primary care

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    2 Information about the technologies

    2.1

    The 3 technologies for diagnosing endometriosis differ in their mechanisms: DotEndo is blood based, Endotest is saliva based and EndoSure is based on gastrointestinal myoelectrical activity (see table 1). The technologies can be used by healthcare professionals in primary care and are intended to be used alongside standard practice. Results from EndoSure are available immediately after testing, whereas Endotest and DotEndo require sample processing in a specialist laboratory that can analyse microRNA biomarkers. All 3 technologies require an additional appointment to discuss the results with a healthcare professional.

    Table 1 Overview of technology features

    Technology name (company), regulatory status

    Technology features and test processing

    Intended age group

    Cost

    EndoSure (3PCM/Endosure)

    UK MDR class 2a

    Measures gastrointestinal myoelectrical activity to detect abnormal electrical patterns in the gut caused by prostaglandins released by endometriosis tissue.

    Results are available immediately after testing

    No lower or upper age limits specified

    Test per person: £350

    Implementation per person:

    • capital: £70.83

    • training: £4.17

    (Capital and training costs were assumed to be spread across 120 people)

    Endotest (Ziwig)

    UK MDR class A, IVDR

    Detects the presence of a 109-microRNA biomarker signature of endometriosis in saliva.

    Samples are sent to the company's centralised laboratory with sequencing capacity

    18 to 43 years

    Test per person: £1,381

    DotEndo (DotLab)

    CE class C, IVDR expected in 2026

    Quantifies endometriosis-specific microRNA biomarker levels in blood.

    Sample processing is not known, but laboratory analysis using polymerase chain reaction is needed

    18 to 49 years

    Test per person: £400

    Abbreviations: CE, Conformité Européenne; IVDR, In Vitro Diagnostic Regulation; MDR, Medical Device Regulation.

    Sustainability

    2.2

    For information, Ziwig's commitment to achieving net zero is published here: Ziwig's environmental responsibility. Ziwig did not disclose its Carbon Reduction Plan. Endosure and DotLab did not disclose their Carbon Reduction Plan for UK carbon emissions or their net zero commitment.