Summary:
Roche’s Elecsys sFlt-1/PlGF ratio test has received FDA clearance, providing a prognostic tool to help stratify pregnant women at risk of severe preeclampsia, improving prediction, intervention, and patient outcomes.

Key Takeaways:

  1. Rising Concern: Preeclampsia rates in the U.S. have increased by 25% in the past two decades, disproportionately affecting Black women.
  2. Clinical Impact: The test enhances clinicians’ ability to predict severe preeclampsia, allowing for better patient management and potentially reducing adverse outcomes.
  3. Scientific Advancement: By identifying angiogenic imbalances early, this biomarker-based test offers a more precise risk stratification tool than current clinical diagnostic criteria.

Roche announced today that the Roche Elecsys sFlt-1/PlGF ratio for preeclampsia has received 510(k) clearance from the United States Food and Drug Administration (FDA). The ratio is a prognostic test intended to stratify hospitalized pregnant women with hypertensive disorders of pregnancy into low- and high-risk categories for developing severe preeclampsia within two weeks of testing. Identifying patients at high risk for severe preeclampsia can lead to better prediction, earlier interventions and reduced adverse outcomes.1 

Preeclampsia Rates in US Have Increased 25%

In the U.S., preeclampsia has increased 25% in the last two decades and is a leading cause of maternal and fetal illness and death.2 Black women in particular experience higher rates of maternal and adverse fetal and neonatal outcomes than other racial and ethnic groups and are at greater risk for developing hypertensive disorders of pregnancy than other pregnant women.3

“There is a great need for highly reliable tools, such as the Elecsys sFlt-1/PlGF ratio, to address severe preeclampsia. We are eager to partner with our customers so this prognostic test can help clinicians plan care and improve patient outcomes,” says Brad Moore, president and CEO at Roche Diagnostics North America.

sFlt-1 and PlGF are key biomarkers in the formation of blood vessels during pregnancy. However, an angiogenic imbalance of these key biomarkers has been proven to play an important role in the development of preeclampsia. Their concentrations in maternal serum are altered even before the onset of the disease, making them a valuable tool for predicting preeclampsia progression.4,5 Nearly 70% of women with a sFlt-1/PlGF ratio greater than 38 delivered their babies within two weeks.1

“The current clinical diagnostic criteria are poor in predicting, with accuracy, the development of preeclampsia among patients with hypertensive disorders of pregnancy. The clearance of this ratio provides clinicians with an additional tool to predict the risk of severe preeclampsia and support clinical management by increasing surveillance in high-risk patients or prolonging pregnancy in low-risk patients, ultimately preventing adverse maternal, fetal and neonatal outcomes,” says Sarosh Rana, MD, MPH, FACOG, University of Chicago Medicine

Preeclampsia is defined as the new onset of hypertension and proteinuria after 20 weeks of gestation, or in the absence of proteinuria, new-onset hypertension and any of the following: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or new onset of headache unresponsive to medication.6 Preeclampsia can be treated only by removal of the placenta at delivery.6 The clinical presentation of preeclampsia and the subsequent clinical course of the disorder can vary tremendously, making prediction, diagnosis and assessment of progression difficult.6

“The FDA clearance of the sFlt-1/PlGF ratio on Roche platforms is a major milestone in the quest to solve preeclampsia. This test will give clinicians an additional tool to stratify women at highest risk for the development of severe preeclampsia. Preeclampsia biomarker testing has the potential to spur innovation in new therapies that are sorely needed for these patients,” Ravi Thadhani, MD, MPH, executive vice president of Health Affairs at Emory University.

Warning Signs Are Often Overlooked

Preeclampsia and its symptoms, such as headaches, visual changes, epigastric pain, and shortness of breath,6 have warning signs that are often overlooked and have devastating and lasting impact on mothers and babies if not properly managed.7 Impacts can include maternal organ damage and an increased risk of future heart failure, preterm birth6and avoidable mental trauma.8 Hospitalization is typically recommended to evaluate the potential for progression to severe disease. Standard diagnostic markers for preeclampsia are often nonspecific and may not accurately predict the severity of the condition or associated adverse outcomes in the subsequent days and weeks.7

The preeclampsia ratio aligns with Roche’s commitment to lead with science in order to develop transformational solutions that improve patient outcomes and simplify lab operations. Roche provides an unrivaled ability to scale access to testing at speed for those who need it most. With an extensive U.S. installation base of more than 4,000 cobas® analyzers and a high degree of menu consolidation across various indications, clinicians are supported in making faster, more efficient clinical decisions, providing the ability to scale testing at speed for even more women.

Featured Image: Yee Xin Tan | Dreamstime.com

References

  1. Berg A, Bautista M, Guo G, et al. Circulating angiogenic factors for stratifying the risk of preeclampsia with severe features. SMFM Global Meeting 2024. Pregnancy 2025. 
  2. Cameron, et al. Trends in the incidence of new-onset hypertensive disorders of pregnancy among rural and urban areas in the United States, 2007 to 2019. J Am Heart Assoc. 2022;11:e023791.
  3. Davis NL, Smoots AN, Goodman DA. Pregnancy-Related Deaths: Data from 14 U.S. Maternal Mortality Review Committees, 2008-2017. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services;2019. 
  4. Levine RJ, et al. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med 2004;350:672–83. 
  5. Zeisler H, et al. Predictive value of the sFlt-1:PlGF ratio in women with suspected preeclampsia. N Engl J Med 2016;374:13–22.  
  6. Gestational hypertension and preeclampsia. ACOG Practice Bulletin No. 222. American College of Obstetricians and Gynecologists. Obstet Gynecol 2020;135:e237–60.
  7. Burwick RM, Rodriguez MH. Angiogenic Biomarkers in Preeclampsia. Obstet Gynecol. 2024;143(4):515-523. 
  8. Not Just Physical: The Psychological Burden Of Preeclampsia And HELLP Syndrome. 
  9. Backes CH, et al. Maternal Preeclampsia and Neonatal Outcomes. J Pregnancy. 2011;214365. 
  10. Pregnancy Mortality Surveillance System.
  11. Hoyert DL. Maternal mortality rates in the United States, 2022. NCHS Health E-Stats. 2024.
  12. Method Sheet Elecsys sFlt-1/PlGF ratio for preeclampsia. 2025 v 1.0. English.
  13. Thadhani, et al. Circulating angiogenic factor levels in hypertensive disorders of pregnancy. NEJM Evid 2022;1:(12).Â