Assay development for the assessment of pregnancy risks in early pregnancy

Prenatal diagnostics play a pivotal role in early identification and management of pregnancy-related risks, yet current methods lag in detecting conditions like fetal growth restriction and preeclampsia in the first trimester. Akna Health Inc.'s CerviGuard diagnostic platform represents a groundbreaking advancement, aiming to fill this critical gap by utilizing trophoblast-specific biomarkers identified in cervical fluid samples for early risk stratification during the first trimester of pregnancy. Patient specimens are collected noninvasively in an office setting, using the same procedure as a PAP smear. The proposed Phase II study builds upon successful preliminary findings to validate the clinical utility of the CerviGuard assay. Specific Aim 1 is a clinical utility study to refine and validate a biomarker panel for early detection of adverse pregnancy outcomes, employing a learning set of 100 participants followed by a broad-scale validation with 500 participants. This aim incorporates cutting-edge machine learning and predictive modeling techniques to achieve unparalleled accuracy in pregnancy risk stratification. Additionally, the development of proprietary antibodies will enhance assay specificity and reliability, creating valuable intellectual property. Specific Aim 2 endeavors to broaden the assay's clinical applicability by adapting the discovery approach for compatibility with flow cytometry, facilitating widespread adoption in clinical laboratories. The conversion to flow cytometry will be rigorously validated through a series of milestones, ensuring that the assay's diagnostic accuracy and reliability are maintained across platforms. Supported by a robust foundation of preliminary research, strategic collaborations, and a dedicated team, this project promises to significantly advance the field of prenatal diagnostics. By enabling early identification of at-risk pregnancies, CerviGuard has the potential to transform prenatal care, offering personalized, preemptive interventions that safeguard maternal and fetal health. The successful completion of this study will pave the way for extensive multicenter trials and commercialization, marking a decisive step toward reducing the incidence of pregnancy-related complications, reducing healthcare expenditures and enhancing prenatal care outcomes.