Overview
The goal of this study is to create a non-invasive diagnostic test to rule out gynecological cancer in females aged 45 and older with abnormal uterine or postmenopausal bleeding.
Eligibility
Inclusion Criteria:
- Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.
- Willing and able to comply with scheduled visits, study plan, and other procedures.
- Expected to be available for the duration of the study and can be contacted by telephone during study participation.
- Females aged 45 and older (with roughly 80% of enrolled subjects over the age of 50).
- Presence of uterus.
- AUB or PMB being worked up to diagnose the cause of the bleeding
Exclusion Criteria:
- Investigator site staff members directly involved in the conduct of the study and their family members or subjects who are PinkDx, Inc. employees or their family members.
- Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator.
- Women who have had a hysterectomy.
- Women with a known history of endometrial cancer or uterine sarcoma.
- Women who have received prior treatment for endometrial cancer.
- Inability or unwillingness to sign informed consent.
- Clinical suspicion of pregnancy.
- Women who have used a tampon within 7 days of sample collection.