Invention:
This technology is a non-invasive diagnostic for the screening and detection of adenomyosis. This could be used for women who are suffering with symptoms of chronic pelvic pain and adenomyosis for diagnosis without an invasive hysterectomy. In preliminary studies, there have been high acceptance of a particular sampling, that can provide information reflecting uterine conditions due to anatomical continuity across the female reproductive tract. Thus, non-invasive sampling may allow detection of adenomyosis-related metabolites and proteins in the cervicovaginal microenvironment, which would address this urgent unmet need. Candidate biomarkers have been identified for non-invasive diagnosis of adenomyosis in cervicovaginal lavages by integrating immunoassays and metabolomics analyses.
Background:
Adenomyosis is a highly prevalent yet enigmatic disease that can be diagnosed only via histopathology among women undergoing hysterectomy, thus, leading to underdiagnosis. Research progress on adenomyosis has been limited due to a variety of challenges:
- Adenomyosis lacks both a clear etiology and clinical/pathological phenotyping
- There are no established diagnostic guidelines
- There are no clear criteria for assessment of treatment response
- Adenomyosis co-occurs with other gynecologic conditions
Based on the challenges outlined, little work has been done on non-invasive diagnostics for adenomyosis, and currently there is no FDA-approved non-invasive method for early detection of adenomyosis, as it is only diagnosed by surgical intervention. Thus, there is an urgent and unmet need for identifying novel diagnostic biomarkers and pathophysiological mechanisms based on non-invasive sampling, which could lead to earlier intervention and treatment.
Applications:
Advantages:
- Non-invasive
- Early detection
- Early treatment
- Easier than current methods