NIH-funded research Sbir 2 grant

Early pregnancy risk test using cervical (Pap-smear) fluid

Official title: Assay development for the assessment of pregnancy risks in early pregnancy

Funded at Akna Health LLC · NIH-11069534 · Data updated 2026-11-12

This project uses a Pap-smear-like cervical sample to look for markers in the first trimester that might signal risks like preeclampsia or poor fetal growth.

Quick facts

Grant typeSbir 2 grant
Study typeNIH-funded research
Funding institutionAkna Health LLC
NIH-funded
Lab location1 site (Grand Rapids, United States)
Project startAugust 18, 2022
Project endAugust 31, 2027
Funding year2025
Award (this year)$1,949,879
NIH project number2R44EB033715-02
Project IDNIH-11069534 on NIH RePORTER

Who could benefit from this research

Could help

Pregnant people in their first trimester who are willing to provide a cervical sample and allow pregnancy follow-up would be the ideal candidates.

Less likely to help

People who are not pregnant, are past the first trimester, or already have a confirmed diagnosis that the test would not change may not benefit.

What this research studies

If I join, a small cervical sample will be taken in the clinic using the same simple procedure as a Pap smear. Researchers will look for placenta-derived (trophoblast) biomarkers in that fluid and use machine learning on an initial group of 100 people and a larger group of 500 to find a reliable marker panel. The team is also making specific antibodies to improve the test and adapting the method so it can work on common lab machines like flow cytometers. Participation involves sample collection and routine pregnancy follow-up so researchers can compare early markers to pregnancy outcomes.

Why it matters

Potential benefit: If successful, the test could spot high-risk pregnancies earlier in the first trimester so people can get closer monitoring or earlier treatment.

How similar studies have gone: Early pilot data were promising, but this larger validation is needed to confirm the test works reliably in more people.

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

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.