Plasma-based Ectopic Pregnancy Diagnostic Test

Ectopic pregnancy (EP) is a major cause of maternal morbidity and responsible for 6% of pregnancy-related deaths worldwide (1). Currently, there is no single non-invasive test for early diagnosis of EP, rather serial ultrasound examinations and longitudinal human Chorionic Gonadotropin (hCG) monitoring are the standard of care. The extended time frame necessary for sequential monitoring to determine an EP diagnosis increases a mother’s risk of an EP-related rupture. In addition prior to pregnancy failure or tubal rupture, nearly a third of EP cases are not detected with current diagnostics and 9% show no symptoms at all (2).

There is a critical need for a reliable Ectopic Pregnancy diagnostic test with timely and accurate disease detection. Specifically, a cost effective and efficient assay is needed to screen patients with and without symptomology to detect the presence of EP.

Validation of selected candidate biomarkers for EP has been performed using multiple reaction monitoring analyses. ADAM-12 was selected for further evaluation and tested in a large independent cohort of EP and control samples. ADAM-12 expression level alone identified EP from control at a sensitivity of 70% and specificity of 84% (4). Further clinical studies will help to identify combination biomarker profiles to increase accuracy and selectivity for diagnostic utility (5).

Pending US patent applications cover compositions and methods of use. 13/397442. 

This technology has been exclusively optioned.

1. Hoover KW et al. Obstet Gynecol. 2010 115(3):492-502. PMID: 20177279
   
   
2. Barnhart KT. N Engl J Med. 2009 Jul 23;361(4)379-387. PMID: 19625718
   
   
3. Beer LA et al. J Proteome Res. 2011 Mar 4;10(3):1126-1138. PMID: 21142075
   
   
4. Rausch ME et al. Fetil Steril. 2011 Mar 15;95(4):1373-1378. PMID: 21277576
   
   
5. Barnhart K and Speicher DW. Expert Rev Mol Diagn. 2011 Nov;11(8)759-762. PMID: 22022935