A diagnostic test to determine both the viability and location of an early pregnancy through a panel of biomarkers.

25% of clinically recognized pregnancies result in miscarriage and 1-2% result in an ectopic pregnancy (EP). The diagnosis can be devastating, and EP can be life-threatening. Up to 33% of pregnant women present with vague abdominal pain or bleeding symptoms in the first trimester and require a pelvic exam, blood tests, and ultrasounds to determine pregnancy status. Even after undergoing such tests, clinicians are unable to determine the status of early pregnancy for up to 40% of women.  Therefore, we need an improved method for detecting miscarriage and EP that is non-invasive and conclusive. 

The inventors developed a non-invasive diagnostic test to determine an early pregnancy's viability and location.  The test uses a panel of biomarkers to detect early pregnancy viability, location, or both. Biomarkers have cutoff thresholds to minimize false positives and false negatives. A multi-tiered algorithm maximizes sensitivity and specificity for each metric (viability and location). The results are combined to give a final pregnancy diagnosis.

• Less invasive than the combination of pelvic exams, blood tests, and ultrasounds. 
• Less time-consuming for healthcare professionals and patients.
• Assesses both miscarriage and ectopic pregnancy in one test.
• Maximizes accuracy, specificity and sensitivity for each condition.