Non-Invasive Early-Pregnancy Diagnostic for Miscarriage and Ectopic Pregnancy

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

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.

Stage of Development: