Aditxt subsidiary Pearsanta has started enrolment in a clinical trial to assess the blood-based Mitomic Endometriosis Test (MET), aimed at the early identification of endometriosis.
The prospective trial is aimed at comparing the MET’s specificity and sensitivity against laparoscopic diagnosis, which is the current definitive method for diagnosing the condition.
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It is set to enrol up to 1,000 subjects who are being referred for diagnostic laparoscopy. As part of the study, each subject will be asked to provide a pre-operative blood sample for analysis.
The study will evaluate the performance of the test across various subtypes of the disease to understand its use in various clinical scenarios.
In addition, it will investigate potential links between MET outcomes, patient symptomatology, and demographic factors to enhance diagnostic approaches.
The establishment of a biobank of clinical samples is also planned, which will enable future research, discovery of biomarkers, and product development initiatives.
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By GlobalDataThe findings from this study are expected to facilitate the MET鈥檚 launch as a laboratory-developed test (LDT) within Pearsanta’s lab in Virginia, US.
Pearsanta president Chris Mitton said: 鈥�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.
鈥淏y targeting mitochondrial DNA (mtDNA) deletions, MET is designed as a non-invasive alternative to current surgical diagnostic approaches, bringing us closer to delivering earlier, more accessible detection for patients affected by endometriosis.鈥�
MET is based on the Pearsanta鈥檚 Mitomic Technology, which detects disease-associated molecular signatures using mtDNA biomarkers.
This approach aims to allow for earlier detection of endometriosis through a simple blood draw.
Aditxt CEO and co-founder Amro Albanna said: 鈥淎dvancing our subsidiary Pearsanta into human trials marks an important milestone. Delays in diagnosing conditions such as endometriosis represent some of the most critical gaps in women鈥檚 health, affecting millions with few reliable diagnostic options.鈥�
