CerviGuard: a simple blood-free screen for pregnancy risks in early pregnancy
Official title: Assay development for the assessment of pregnancy risks in early pregnancy
Funded at Akna Health LLC · NIH-11418895 · Data updated 2026-11-12
A new noninvasive cervical-fluid test called CerviGuard aims to identify pregnancy risks in the first trimester so clinicians can better manage conditions like fetal growth issues and preeclampsia.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Akna Health LLC NIH-funded |
| Lab location | 1 site (Grand Rapids, United States) |
| Project start | August 18, 2022 |
| Project end | August 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $1,318,850 |
| NIH project number | 5R44EB033715-03 |
| Project ID | NIH-11418895 on NIH RePORTER |
Who could benefit from this research
✓Could help
Pregnant individuals in the first trimester who are seeking prenatal screening.
✕Less likely to help
Tests may not improve outcomes for pregnancies without these specific risk signals or in settings where the test cannot be implemented.
What this research studies
This project uses a noninvasive cervical-fluid test collected in an office visit (like a Pap smear) to look for trophoblast-related biomarkers in early pregnancy. It combines a biomarker panel with machine learning to predict adverse pregnancy outcomes and guides how patients are monitored or treated. The study plans to validate the panel with 100 learning participants and 500 in the broader validation, while developing antibodies to improve test reliability and exploring flow cytometry adaptation for wider lab use.
Why it matters
Potential benefit: If successful, CerviGuard could provide earlier and more accurate risk stratification in pregnancy, enabling timely care to reduce complications.
How similar studies have gone: Previous pilots have shown promise, and this project aims to validate a refined biomarker panel in a larger cohort.
Where this research is happening
-
Akna Health LLC
Grand Rapids, United States Active
Researchers
- Principal investigator: Drewlo, Sascha — Akna Health LLC
- Study coordinator: Drewlo, Sascha
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.