preecludiaTM

Preeclampsia rule-out test 
(currently in development)


For patients presenting with signs and symptoms of possible preeclampsia from 28 to up to 37 weeks' gestation.

Pregnant woman getting blood pressure checked by doctor.

A potential breakthrough advancement

We are developing the Preecludia preeclampsia rule-out test to help physicians evaluate and manage their patients in a whole new way.

For the first time in the US, physicians will have a test based on measuring biomarkers of the underlying pathophysiology of preeclampsia – not just non-specific symptoms.

The Preecludia test will help physicians clearly assess risk and make confident management decisions, while providing peace of mind to patients.

What is preeclampsia?

Preeclampsia is a syndrome of pregnancy characterized by high blood pressure, multi-organ injury, and fetal compromise. This condition is primarily defined by its symptoms:

Approximately 30% of all pregnant women have one of these symptoms and are assessed for preeclampsia.1

Prevalence and impact of preeclampsia

Occurs in 5–8% of pregnancies in the United States2US Map overlayed with percentage illustration
Between 8-20% of all pregnant women have at least one risk factor.2Pregnant woman holding her stomach illustration
Preeclampsia is the #2 cause of maternal mortality.3Heart with heartbeat blip line illustration

Preeclamptic pregnancies are costly

Preeclampsia has a significant impact on patient outcomes, which comes at a cost to the US healthcare system.


Total costs of preeclamptic pregnancy are 3x that of normal pregnancy.4

Cost breakdown chart

Data from 2019

A father holding his son.

The high cost of preeclampsia is driven by:

  • Infant costs linked to premature delivery
  • Longer hospital stays for infants
  • Higher C-section rates
  • Other maternal adverse events4

The clinical dilemma

More than 700,000 women present with signs and/or symptoms of preeclampsia each year.5-7

However, methods for diagnosis of preeclampsia are nonspecific and have not changed significantly since the 1800s. Current triage assessment is cumbersome and can miss up to 50% of adverse neonatal outcomes.8

There is a significant unmet clinical need to better identify and assess symptomatic patients to determine those at risk and those at reduced risk of developing preeclampsia.

Our solution

Physicians need better risk assessment tools for preeclampsia based on the pathophysiology of the syndrome, not just the symptoms.

Ruling out preeclampsia in symptomatic patients has the potential to:

  • Lead to greater precision and accuracy of diagnosis
  • Reduce hospitalization and medical intervention
  • Prevent unnecessary preterm delivery
  • Decrease healthcare costs
  • Improve outcomes for mother and baby
  • Provide peace of mind for patients
Preecludia Product Box

Preecludia test has the potential to become the first U.S. preeclampsia rule-out test

We developed the Preecludia test to help healthcare providers rule out possible preeclampsia with confidence. This multi-analyte test assesses biomarkers of both placental and maternal health.

The Preecludia rule-out test has the potential to reduce costs and improve patient outcomes. Providers can return patients to routine care, decreasing healthcare over-utilization, and identify at-risk patients early to improve interventions and care management.

  • Noninvasive
  • Multi-analyte test
  • High sensitivity*
  • High negative predictive value*

* Based on verification data. Validation data not yet published.

Clinical Development Roadmap

Test developed with >3,700 patients

Clinical Validation: PRO-104 Study

  • Achieved primary endpoint of validation study protocol
  • Demonstrated strong performance and a high NPV level in line with original target at high prevalence rate and in a broad use population
  • Received patent on methods for testing free and dissociated PlGF
  • Proceeding toward publication of results in peer-reviewed journal

Feasibility & Optimization:
PRO-105 Study

  • Develop algorithm training & test sets

Verification: PRO-129 Study

  • Prospective, blinded clinical verification data from 376 patients9
  • Supports a rule-out window up to 14 days in the target population
SensitivitySpecificityNPV
87.8% (75.8% - 94.3%)76.8% (71.2% - 81.5%)97.0% (93.6% - 98.6%)

Clinical Development Strategy

  • Market education and development
  • Initiate trials with partner to evaluate clinical utility
  • Develop health economics data
  • Targeted publication of key data
Preeclampsia Virtual R&D Day Learn more about ongoing clinical development of the Preecludia rule-out test for preeclampsia. Watch this presentation from November 2020 to see how we are helping address unmet needs in preeclampsia.

References

  1. Data on file, Progenity market research.
  2. Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020; 135(6):e237-e260.
  3. Henderson JT, Thompson JH, Burda BU, Cantor A. Preeclampsia Screening: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2017;317(16):1668-1683.
  4. This research was presented at the Society for Maternal-Fetal Medicine (SMFM) Annual Pregnancy Meeting and subsequently published in Obstetrics & Gynecology. Hao J, Hassen D, Hao Q, et al. Maternal and Infant Health Care Costs Related to Preeclampsia. Obstet Gynecol. 2019;134(6):1227-1233.
  5. Ananth CV, et al. Pre-eclampsia rates in the United States, 1980-2010: age-period-cohort analysis. BMJ. 2013 Nov 7;347:f6564.
  6. ScienceDirect. Gestational Hypertension — an overview. Available at: https://www.sciencedirect.com/topics/medicine-and-dentistry/gestationalhypertension.
  7. Center for Disease Control and Prevention. Births: Final Data for 2018. https://www.cdc.gov/nchs/nvss/births.htm
  8. Lai J, Syngelaki A, Nicolaides KH, et al. Impact of new definitions of preeclampsia at term on identification of adverse maternal and perinatal outcomes. Am J Obstet Gynecol 2020.
  9. Cooper M, et al. Performance of a novel multi-biomarker rule-out preeclampsia test: a prospective verification study. Poster presented at the 2021 ACOG Annual Clinical and Scientific Meeting.