Aditxt subsidiary Pearsanta has secured approval from WCG Clinical’s Institutional Review Board (IRB) to begin a clinical trial of the blood-based Mitomic Endometriosis Test (MET).
This diagnostic test is intended to support the early identification of endometriosis.
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The study, titled ‘Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting with Symptoms of Endometriosis’, is set to assess the test’s clinical performance against laparoscopic diagnosis.
It aims to enrol up to 1,000 referred subjects for diagnostic laparoscopy. They will be required to fill out a symptom questionnaire and submit a blood sample before the operation. Enrolment is anticipated to start next month.
According to the company, the study aims to assess the MET’s specificity and sensitivity against laparoscopic diagnosis and evaluate its performance across different subtypes of the disease.
The goals also include exploring correlations between the test outcomes, demographic variables, and symptom profiles.
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By GlobalDataAdditionally, the study will set up a clinical sample biobank for future research and product development.
The outcomes from this trial are said to aid in launching MET as a laboratory-developed test within the company’s US lab.
The MET utilises Pearsanta’s Mitomic Technology, which leverages mitochondrial DNA biomarkers for identifying molecular signatures related to the condition, via a blood draw.
Endometriosis is said to result in infertility, irreversible organ damage, and chronic pain due to diagnostic delays.
Pearsanta president Chris Mitton said: “This study will generate real-world data on the clinical performance of MET in a pre-surgical population, helping us evaluate its accuracy across symptom profiles and disease subtypes.
“By targeting mitochondrial DNA deletions, MET is designed as a non-invasive alternative to current surgical diagnostic approaches, potentially bringing us closer to delivering earlier, more accessible detection for patients affected by endometriosis.”
Last month, Pearsanta acquired patents related to adductomics-based DNA damage detection, which could lead to advancements in cancer diagnostics.
