Preeclampsia screening: where biomarker-based pathways are converting
Preeclampsia screening has moved from clinical-risk-factor-driven to biomarker-augmented pathways in several markets. The methodology, the access frame, and the implications for both maternal outcomes and commercial planning around adjacent assets are worth understanding.
What preeclampsia screening looks like now
Preeclampsia is hypertensive disease of pregnancy, accounting for substantial maternal and fetal morbidity globally. Screening has historically been clinical-risk-factor-driven (history of preeclampsia, hypertension, diabetes, autoimmune disease, age, parity), with prophylaxis (low-dose aspirin) offered to high-risk patients.
The shift in the past five to ten years has been toward biomarker-augmented screening:
- First-trimester combined screening: Maternal characteristics, blood pressure, uterine artery Doppler, and biochemical markers (PAPP-A, PlGF) combined in a risk algorithm to identify patients at high risk of preterm preeclampsia
- sFlt-1/PlGF ratio: A second-trimester and third-trimester ratio used to rule in or rule out preeclampsia in patients with suggestive symptoms
The first-trimester combined screening approach has the strongest evidence base and is endorsed by FIGO, ISUOG, and (with more conditional language) NICE and ACOG.
Where the access pathways have converted
Adoption of first-trimester combined screening varies markedly across major markets:
- UK and parts of Europe: NHS implementation in some regions, with ongoing rollout
- US: variable adoption, driven by individual health systems rather than national policy
- Asia-Pacific: strong adoption in private healthcare in some markets, slower in public systems
The sFlt-1/PlGF ratio is more broadly available because the assay is simpler and the use case (rule in or rule out symptomatic patients) is more clearly defined.
What this means for commercial planning
For sponsors of preeclampsia-relevant assets:
- Biomarker assay infrastructure is the patient-finding pathway. Therapeutic assets in development for preeclampsia or for high-risk pregnancy depend on the screening infrastructure to identify the eligible patient population
- Low-dose aspirin prophylaxis is the established intervention but is under-implemented. The intervention is well-evidenced and widely available, and the gap between the eligible population and the prophylaxis-receiving population is wide
- Novel preeclampsia therapeutics in development face a screening-infrastructure-dependent commercial environment. Sponsors need to engage with the screening pathway as part of the launch operating model, not as a post-launch optimisation
What we are watching
- Adoption of first-trimester combined screening in markets where it is endorsed but not yet widely implemented
- Late-stage preeclampsia therapeutic pipeline and how it positions relative to the screening pathway
- Real-world data on aspirin prophylaxis uptake and the operational interventions that close the eligible-population-to-prophylaxis gap
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