The Lumella® Test, The New Point-of-Care Blood Test Helps in Early Detection of Preeclampsia

The Lumella® test estimates the concentration of Glycosylated Fibronectin, a new pregnancy specific biomarker to accurately assess the risk of preeclampsia.

The Lumella® test requires a simple finger stick and can be performed in physician’s office/clinic in the first, second, or third trimesters, between 13 to 37 weeks of gestation.

What is Preeclampsia?

Preeclampsia is a potentially life-threatening disorder that occurs during pregnancy or the postpartum period. It affects 5-8% of all pregnancies and is characterized by high blood pressure, presence of protein in the urine. Symptoms include swelling, sudden weight gain, recurrent headaches, changes in vision, upper abdominal pain, nausea and vomiting. Some women with preeclampsia may not show any symptoms. Progression to severe preeclampsia is unpredictable. Early detection of preeclampsia prevents adverse complications and improves maternal and fetal outcomes.

LEFT UNDETECTED, PREECLAMPSIA CAN RAPIDLY PROGRESS TO A POTENTIALLY FATAL CONDITION

Key Statistics About Preeclampsia

  • Hypertensive disorders of pregnancy (HDPs) complicate 5-10% of all pregnancies worldwide. They include: preeclampsia (with or without severe features), eclampsia (seizures), HELLP syndrome (hemolysis, elevated liver enzymes, low platelets), and gestational hypertension.[1]
  • Preeclampsia is most often characterized by a rapid rise in blood pressure that can lead to seizure, stroke, multiple organ failure, and death of the mother and/or baby.
  • HDPs are a leading cause of maternal and infant death worldwide[2], with the majority of these deaths happening in low- and middle-income countries (LMICs).
  • Approximately 76,000 women and 500,000 babies die each year worldwide.[3]
  • The United States currently ranks 47th worldwide for maternal mortality, and is the only industrialized nation with a rising maternal mortality rate.[4]
  • HDPs, including preeclampsia, are a leading cause of maternal and infant illness and death here in the United States.[5]
  • Black women experience severe maternal morbidity events at a rate 2.1 times greater than white women.[6]

Source: Preeclampsia.org

7 Symptoms Every Pregnant Woman Should Know
(tambien disponible en Español)
Postpartum Preeclampsia: Still At Risk
(tambien disponible en Español)

Risk Factors

Preeclampsia is a common complication of pregnancy that can harm you and your baby. Risk factors include:

History of Preeclampsia
A personal or family history of preeclampsia significantly raises your risk of preeclampsia.
First Pregnancy
The risk of developing preeclampsia is highest during your first pregnancy.
New Paternity
Each pregnancy with a new partner increases the risk of preeclampsia over a second or third pregnancy with the same partner.
Age
The risk of preeclampsia is higher for pregnant women under 18 or over 40.
Obesity
The risk of preeclampsia is higher if you are obese.
A Multiple Pregnancy
Preeclampsia is more common in women who are carrying twins, triplets or other multiples.
Interval Between Pregnancies
Having babies less than one year apart or more than 10 years apart leads to a higher risk of preeclampsia.
History of Certain Conditions
Having certain conditions before you become pregnant — such as high blood pressure, diabetes, kidney disease, a tendency to develop blood clots, or lupus — increases your risk of preeclampsia.

Lumella® A Point-of-Care Test for Preeclampsia

Lumella® Preeclampsia Test

A new point-of-care blood test to help determine your risk for Preeclampsia

This test only requires a simple finger stick and can be performed in your physician’s office during the first, second, or third trimester of your pregnancy.

CE marked
Not available for sale in the USA.
Granted FDA breakthrough status on December 5, 2019.

Reference Materials

Lumella® Brochure

Lumella® Test Quick Reference Guide
(Italian version)

Quick Reference Guide Addendum
(Italian version)

Lumella® Test Video Procedure

Lumella® Patient Education:
Headaches Brochure | Weight Brochure | Symptoms Brochure

Publications

Citations

  1. Ye, C., Ruan, Y., Zou, L., Li, G., Li, C., Chen, Y., … Zhang, W. (2014). The 2011 Survey on Hypertensive Disorders of Pregnancy (HDP) in China: Prevalence, Risk Factors, Complications, Pregnancy and Perinatal Outcomes. PLoS ONE, 9(6), e100180. http://doi.org/10.1371/journal.pone.0100180
  2. Khan KS, Wojdyla D, Say L, Gulmezoglu M, Van Look PF. WHO analysis of causes of maternal death: A systematic review. Lancet 2006; 367:1066-74.
  3. Salam R. A., Das, J. K., Ali, A., Bhuamik, S., and Lassi, Z.S. (2015). Diagnosis and management of preeclampsia in community settings in low and middle-income countries. Journal of Family Med Prim Care, 4(4), 501–506. http://doi.org/10.4103/2249-4863.174265
  4. MacDorman, M., Declercq, E., Cabral, H., Morton, C., Is the United States Maternal Mortality Rate Increasing? Disentangling trends from measurement issues: Short title: U.S. Maternal Mortality Trends. Journal of Obstetrics and Gynecology. September, 2016.
  5. Center for Disease Control Pregnancy Mortality Surveillance System: https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm
  6. Racial Disparities Persist in Maternal Morbidity, Mortality and Infant Health: https://www.ajmc.com/view/racial-disparities-persist-in-maternal-morbidity-mortality-and-infant-health
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