The GestAsssured® test

 


The GestAssured® test is a rapid diagnostic test for preeclampsia that is currently in development.
This novel test is based on research led by two doctors seeking tools for diagnosing preeclampsia. They discovered protein that is misfolded and aggregated in urine of women who have preeclampsia. Research has shown a strong correlation between preeclampsia and the presence of these misfolded proteins.1-3 Detecting these proteins in urine during a diagnostic workup could provide clarity in the diagnosis of preeclampsia and improve patient management.

GestAssured Test

The GestAssured® test detects misfolded protein in the urine of women who have preeclampsia

The GestAssured® test is designed to be a cost-effective, easy-to-use test that fits into the existing clinical workflow. The GestAssured® test will provide objective, reproducible, preeclampsia-specific information for use by clinicians in conjunction with existing diagnostic directives.

The Congo Red Dot (CRD) Paper Test was first developed by Drs. Irina and Catalin Buhimschi (University of Illinois, Chicago) while at Yale University. With a license from Yale, GestVision has developed the GestAssured® test based on similar principles. The Company has initiated a multi-center US clinical study to evaluate the investigational-use-only GestAssured® test.

Researchers at The Ohio State University Wexner Medical Center conducted a prospective cohort study in 346 pregnant women and found that the CRD Paper Test demonstrated 80.2% sensitivity, 89.2% specificity, 92.1% negative predictive value, and 86.7% accuracy in correctly diagnosing preeclampsia.

Early detection of preeclampsia can help improve healthcare outcomes for both mothers and babies.


References

1. Kara Rood, Catalin S. Buhimschi, Theresa Dible, Shaylyn Webster, Guomao Zhao, Philip Samuels, and Irina A. Buhimschi. Point-of-care congo red dot (CRD) test for antenatal triage and rapid identification of preeclampsia (PE). Am J Obstet Gynecol. Supplement to 2016 Jan: S24.

2. Irina A. Buhimschi, Unzila A. Nayeri, Guomao Zhao, Lydia L. Shook, Anna Pensalfini, Edmund F. Funai, Ira M. Bernstein, Charles G. Glabe and Catalin S. Buhimschi. Protein misfolding, congophilia, oligomerization, and defective amyloid processing in preeclampsia. Sci Transl Med. 2014 Jul 16;6(245):245ra92. PMID: 25031267; DOI: 10.1126/scitranslmed.3008808

3. Irina A. Buhimschi, Guomao Zhao, Edmund F. Funai, Nathan Harris, Isaac E. Sasson, Ira M. Bernstein, George R. Saade, and Catalin S. Buhimschi. Proteomic profiling of urine identifies specific fragments of SERPINA1 and albumin as biomarkers of preeclampsia. Am J Obstet Gynecol. 2008 Nov;199(5):551.e1-16. PMID: 18984079; PMCID: PMC2679897; DOI: 10.1016/j.ajog.2008.07.006

4. Kara M. Rood, Catalin S. Buhimschi, Theresa Dible, Shaylyn Webster, Guomao Zhao, Philip Samuels, Irina A. Buhimschi. Congo red dot paper test for antenatal triage and rapid identification of preeclampsia. E Clin Med. 2019 Feb;8:47-56. DOI: 10.1016/j.eclinm.2019.02.004