# Point-of-care testing for perinatal risks in early pregnancy

> **NIH NIH R43** · AKNA HEALTH LLC · 2024 · $351,600

## Abstract

Background & Significance: Each year, out of 4 million pregnancies in North America, approximately 800,000
are classified as high risk. A striking 20% of these pregnancies develop critical perinatal disorders. The notable
gap in early-stage diagnostic tools underscores a pressing need in perinatal medicine.
Objective & Innovation: We propose a pioneering approach to delineate the clinical relevance of placental
biomarkers, detectable in the cervical canal during the first trimester. Utilizing these biomarkers, we aim to offer
clinicians a cutting-edge diagnostic solution, paving the way for earlier interventions and enhancing the negative
predictive value of current measures.
Approach:
 · Milestone 1: Systematic collection and archival of cervical and blood specimens from 200 high-risk
pregnancies between 10-12 weeks of gestation. Specialized collection kits ensure efficiency, while
informed consent facilitates a secure and comprehensive data collation.
· Milestone 2: Quantitative assessment of biomarker concentrations by ELISA in archived samples.
Targeting five pivotal placenta proteins, we aim to highlight those indicative of pregnancies prone to fetal
growth restriction, miscarriage, or preeclampsia.
· Milestone 3: Establish rigorous correlations between cervical specimen biomarker levels and clinical
outcomes. Advanced regression analysis will determine the relationship between biomarkers and
birthweight. Comprehensive digital records on perinatal pathologies will support correlation analyses,
ROC evaluations, and model-fitting techniques. Projections indicate approximately 18% (or 25) of this
high-risk cohort will experience perinatal complications—evident distinctly in cervical biomarker levels.
Team & Commercialization: Led by a distinguished team with a track record of groundbreaking research in
reproductive health, and supported by experts in clinical perinatology, biomarker detection and data analysis, we
are uniquely positioned to tackle this challenge. Our clear roadmap includes patenting all IP and aspires to launch
a diagnostic kit that will benefit the vast number of high-risk pregnancies, initially with potential for a point-of-care
solution in the clinic and subsequently at home, signaling strong commercial promise.
Feasibility & Impact: With pilot data and a structured methodology, the proposed study is on track to validate
the diagnostic platform, laying groundwork for a more comprehensive Phase II clinical utility validation study.
Early identification of at-risk patients promises a significant reduction in adverse outcomes, offering immense
benefits to both mothers and infants and generating considerable healthcare savings.
Conclusion: Merging in-depth research with tangible clinical benefits, our initiative represents a transformative
shift in early-stage perinatal intervention, with vast implications for a significant portion of pregnancies.

## Key facts

- **NIH application ID:** 10920240
- **Project number:** 1R43EB035958-01
- **Recipient organization:** AKNA HEALTH LLC
- **Principal Investigator:** Sascha Drewlo
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $351,600
- **Award type:** 1
- **Project period:** 2024-09-02 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10920240

## Citation

> US National Institutes of Health, RePORTER application 10920240, Point-of-care testing for perinatal risks in early pregnancy (1R43EB035958-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10920240. Licensed CC0.

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