Approximately 10% of couples trying to become pregnant will not conceive after 12 months. The resulting infertility diagnosis and treatment regimen can be overwhelming to patients. Studies have shown that up to 60% of enrollees will discontinue treatment before achieving a pregnancy; they often cite physical and emotional burden, logistical concerns with repeated clinic visits, and cost as reasons for ending their treatment. At-home diagnostic tests that measure key reproductive endocrinology biomarkers have the potential to remove many of these burdens. Unfortunately, existing at-home tests provide clinical utility to very limited use-cases because: 1) they only measure one or two relevant biomarkers; 2) they require qualitative/subjective analysis; 3) they return results too slowly. In this research, we propose the development of Barcode Embedded Rapid Diagnostic Tests (BERDTs) as an at-home test to measure fertility hormones in urine . These tests have novel spatial patterning of reagents that allows them to be automatically and quantitatively analyzed by a mobile phone application. Once results are determined on the patient?s phone, the application can provide clinical decision support as well as securely share the test results with the patient?s clinician through electronic medical records (EMR). We have assembled an interdisciplinary consortium that consists of biomedical engineering, point-of-care device, and software development expertise (PragmaDx, Inc.), biomarker assay development in the Department of Chemistry at Vanderbilt University, and clinical reproductive endocrinology and infertility expertise at Vanderbilt University Medical Center. To meet our shared goals, our specific aims will: optimize manufacturing conditions, develop and evaluate mobile-phone and server-side software, and rigorously compare the performance of BERDTs to standard clinical laboratory methods using de-identified patient specimens. A successful outcome of this Phase I SBIR will be the development of a diagnostic test and mobile phone software that is capable of measuring multiple hormones in urine at the point-of-care, with accuracy comparable to standard clinical laboratory assays. It will be ready for a rigorous clinical evaluation, which will be the subject of a Phase II SBIR application.
More than 10% of couples trying to conceive will not become pregnant within one year. While treatments can be effective, there are substantial logistical and financial barriers that prohibit enrollment in these services. Accurate at-home hormone measurements have the potential to allow these services to reach broader use.
