Breakthrough Clinical Results
Trinity Biotech plc announced that its New York reference laboratory received regulatory approval from the New York State Department of Health (NYSDOH) to offer the FDA-cleared PreClara™ Ratio (sFlt-1/PlGF) biomarker test for preeclampsia risk assessment. The test, launching in Q3 2025, helps clinicians assess the likelihood of progression to severe preeclampsia in hospitalized pregnant women with hypertensive disorders. Studies suggest significant cost savings through reduced preterm deliveries and NICU admissions. This approval supports Trinity Biotech's maternal health strategy and lays groundwork for the commercial launch of PrePsia™, a preeclampsia risk assessment technology for early pregnancy.
Key Highlights
- NYSDOH approved PreClara™ Ratio (sFlt-1/PlGF) biomarker test for preeclampsia risk assessment.
- Test launch planned for Q3 2025.
- Studies show potential for significant cost savings by reducing preterm deliveries and NICU admissions.
- Approval supports Trinity Biotech's maternal health strategy and paves the way for PrePsia™ launch.
Incidence and Prevalence
Global Incidence and Prevalence of Preeclampsia
Preeclampsia represents a significant global health challenge affecting pregnancies worldwide. According to recent epidemiological data, the global morbidity rate of preeclampsia (PE) ranges between 3-7% of all pregnancies. This common syndrome typically occurs in the second half of pregnancy and is characterized by hypertension and proteinuria.
The condition affects both mother and unborn baby in approximately 5-8% of all pregnancies according to 2013 publications, though another source from the same year indicates a slightly lower range of around 3% to 5% of all pregnancies worldwide. This variation in reported rates highlights the challenges in establishing precise global prevalence figures.
Preeclampsia is a rapidly progressive condition with potentially severe consequences. It is estimated that this disorder is responsible for 76,000 maternal and 500,000 infant deaths each year globally. Furthermore, 10-20% of maternal deaths worldwide are associated with preeclampsia, underscoring its significance as a maternal health concern.
Regional variations exist in the epidemiology of preeclampsia. In India specifically, the incidence of eclampsia (a severe complication of preeclampsia) ranges from 0.179 to 5%, with an average of 1.5% according to data published from 1976 to 2015. A 2020 study from China reported that at Zhongnan Hospital, the prevalence of hypertensive disorders was 7.1%, with preeclampsia specifically accounting for 6.4%.
Racial and ethnic disparities have been observed in preeclampsia rates. A US-based study from 2014 found that non-Hispanic Black women had higher odds of developing mild preeclampsia (AOR = 1.26), severe preeclampsia (AOR = 1.31), or superimposed preeclampsia (AOR = 1.98) compared to non-Hispanic White women. Conversely, Hispanic women and Asian/Pacific Islanders had higher odds of remaining normotensive.
Interestingly, blood type may also influence preeclampsia risk. A 2019 study revealed that women with AB blood type had >3 times the odds of developing late-onset preeclampsia compared to those with O blood type. Among women with early-onset preeclampsia, those with B blood type had 5 times the odds of having a growth-restricted fetus than women with O blood type.
The main hypothesis explaining preeclampsia development is the theory of placental hypoxia/ischemia. An imbalance between vascular endothelial growth factor (VEGF) and soluble fms-like tyrosine kinase-1 (sFlt-1) appears to play a crucial role in its pathophysiology. Currently, there is no way to predict with certainty whether preeclampsia will develop during pregnancy, highlighting the need for improved diagnostic tools to identify and monitor at-risk women.
Economic Burden
Economic Burden of Treating Preeclampsia in USA and Europe
United States
The most recent estimate from a 2017 study shows that the total cost burden of preeclampsia during the first 12 months after birth in the United States was $2.18 billion ($1.03 billion for mothers and $1.15 billion for infants). Preeclampsia increased the probability of an adverse event from 4.6% to 10.1% for mothers and from 7.8% to 15.4% for infants while lowering gestational age by 1.7 weeks.
The cost burden per infant is dependent on gestational age, ranging from $150,000 at 26 weeks gestational age to $1,311 at 36 weeks gestational age.
A 2020 study estimated maternity-related healthcare costs in women with and without severe maternal morbidity (SMM), including conditions like preeclampsia. In the Commercial population, the total per-patient mean costs for women without and with SMM were $14,840 and $20,380 respectively. In the Medicaid population, these costs were $6,894 and $10,134 respectively. SMM was associated with a 37% increase in maternity-related costs in Commercial and 47% increase in Medicaid populations.
A 2022 California cohort study of 1,918,482 women found that hospitalization costs of hypertensive disorders of pregnancy were significantly higher than for women without hypertension. Women with eclampsia had the highest median hospitalization costs ($25,437), while women without any hypertensive disorder had the lowest costs ($11,720).
Europe
In Ireland, based on a 2017 study, the average cost of a pregnancy complicated by preeclampsia was €5,243 per case compared with €2,452 per case for an uncomplicated pregnancy. The national cost of preeclampsia in Ireland is between €6.5 and €9.1 million per annum based on the 5% to 7% prevalence rate among nulliparous pregnancies.
Postpartum care was the largest contributor to these costs (€4.9-€6.9 million), followed by antepartum care (€0.9-€1.3 million) and peripartum care (€0.6-€0.7 million).
In a 2015 study of women with a history of early-onset preeclampsia or HELLP syndrome, maternal hospital costs per patient averaged €8,047 in a European setting. The main cost drivers were maternal admissions and outpatient visits, together accounting for 80% of total costs.
Global Impact
A 2021 study mentions that the lack of an effective therapeutic to prevent or treat preeclampsia is responsible for an annual global cost burden of 100 billion US dollars.
Primary cost drivers were identified as preterm birth and recurrent preeclampsia or HELLP syndrome. Women with preeclampsia generate significantly higher maternity costs than women without preeclampsia.
Preeclampsia also affects women later in life as it is a recognized risk factor for cardiovascular disease, stroke, and vascular dementia, which may contribute to additional long-term healthcare costs.
Drug used in other indications
PreClara™ Ratio (sFlt-1/PlGF) Clinical Trials Beyond Preeclampsia
Based on the available information, there is insufficient data regarding clinical trials of PreClara™ Ratio (sFlt-1/PlGF) for indications other than preeclampsia. The current information does not document any additional medical conditions or diseases for which this diagnostic ratio test is being investigated.
Similarly, there is no available information about the intervention models or study designs being utilized in any trials that might be exploring the use of PreClara™ Ratio for conditions beyond preeclampsia.
The PreClara™ Ratio test, which measures the ratio between soluble fms-like tyrosine kinase-1 (sFlt-1) and Placental Growth Factor (PlGF), is primarily known for its application in preeclampsia assessment. However, the specific details about its potential applications in other clinical scenarios remain undocumented in the available information.
For healthcare professionals interested in the broader applications of this biomarker ratio, further research into recently published clinical trials or direct inquiries to the test manufacturer may be necessary to obtain comprehensive information about ongoing investigations into alternative clinical uses.