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Advancing Accurate Risk Assessment & Clinical Management of Preeclampsia

Introducing the Lumella® GlyFN rapid point-of care test

Early Symptoms of Preeclampsia are often too Ambiguous for Accurate Clinical Stratification

  •  - Clinical presentations often involve uncertain indications of hypertension and proteinuria
  •  - Less than 40% of women exhibit both hypertension and proteinuria before the development of overt preeclampsia
  •  - Preeclampsia progression is unpredictable and often complicated by adverse outcomes

“ Biochemical markers can improve accurate clinical stratification and expectant management ”

Glycosylated Fibronectin (GlyFN) Levels are Elevated in Preeclampsia*

In an observational cohort of 107 pregnant women, 45 normotensive and 62 diagnosed with preeclampsia, glycosylated fibronectin (GlyFN) levels were elevated as early as the first trimester (p<0.001).

*Rasanen et al. Maternal serum glycosylated fibronectin as a point-of care biomarker for assessment of preeclampsia. American Journal of Obstetrics and Gynecology 2015;212:82.e1-9

The Lumella GlyFN Point-of Care Test Accurately Estimates Risk in Women with Suspected Preeclampsia

In a prospective, observational study (SUPERIOR study, 2016-2018), conducted in India among a cohort of 599 women suspected of preeclampsia, GlyFN as a single biochemical marker showed the highest test performance for risk stratification of preeclampsia.

Normal GlyFN
50-250 µg/mL

Correlated with normal pregnancy with high sensitivity of 98.2% and high Negative Predictive Value of 99.4%

Positive GlyFN
351-600 µg/mL

Correlated with biochemical diagnosis of preeclampsia with 98% Positive Predictive Value

High Positive GlyFN
> 600 µg/mL

Correlated with risk of severe preclampsia with 99% Positive Predictive Value

The GlyFN Test is Intended as an Aid in the Diagnosis ® Lumella of Preeclampsia in Women with Suspected Preeclampsia.

...
Testing period: Gestational age 13-37 weeks
  •  - New-onset hypertension •
  •  - New-onset proteinuria •
  •  - Severe headache •
  •  - Changes in vision •
  •  - Abdominal pain •
  •  - Fetal growth restriction •

Introducing the Lumella GlyFN Point-of Care Test

  •  - Measures glycosylated fibronectin (GlyFN)
  •  - Uses 5 µL finger prick blood sample
  •  -  Results in 10 minutes

Clinical Interpretation of Test Results

GlyFN range Test Result Interpretation
50-250 µg/mL Normal 99.4% Negative Predictive Value for normal pregnancy
251-350 µg/mL Abnormal Mild or Developing Preeclampsia, repeat testing in 2 weeks
351-600 µg/mL Positive 98% Positive Predictive Value for diagnosis of preeclampsia
>600 µg/mL High Positive High risk of severe preeclampsia and adverse outcomes
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