Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers

Inclusion Criteria16

• Able to understand and provide informed consent.
• Natural born female of childbearing potential.
• Age between 18 and 50, inclusive.
• Not pregnant at Visit 0 (screening) or Visit 1 (day of procedure).
• Free of systemic or pelvic disorder that, in the opinion of the investigator, may interfere with the tissue collection procedure, analysis of the tissue or increase the risk to subject.
• Must not have received excision or ablation surgical procedure or treatment, such as gonadotropin-releasing hormone (GnRH), for endometriosis within the past 12 months.
• For Cohort 1 and 2:
• Suspected of having endometriosis, or previously diagnosed with endometriosis, and currently recommended for laparoscopic surgery by physician.
• Must have laparoscopic surgery within 60 days after screening Visit 0 and any time after the endometrial biopsy is obtained on Visit 1 (including the same day), or a laparoscopy on record within the 12 months prior to Visit 0 for diagnosis only.
• Surgical report from prior laparoscopy must indicate that endometriosis was not treated with surgical ablation or excision.
• Subjects will be assigned to Cohort 1 or 2 based on diagnosis and staging results from laparoscopy.
• Or for Cohort 3:
• Not suspected of having endometriosis
• no previous diagnosis or symptoms of endometriosis, who have had a laparoscopy for another reason, such as tubal ligation or other abdominal procedure, within the past 12 months prior to screening Visit 0,
• or laparoscopy to be completed within 60 days after screening Visit 0 and any time after the endometrial biopsy is obtained on Visit 1 (including the same day).
• Surgeon's report must have no supplemental observations of endometriosis lesions or diagnosis. Subjects will be assigned to Cohort 3.