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Introducing the GlyFN ®Lumella rapid point-of care test

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

Lumellarapid
Lumellarapid

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 ”

Dr. Michael Gravett, Dept of Obgyn, University of Washington Medical Centre, Seattle, USA

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)

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*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

Testing period: Gestational age 13-37 weeks

New-onset hypertension

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New-onset proteinuria

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Severe headache

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Changes in vision

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Abdominal pain

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Fetal growth restriction

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LumellaTestN-GenWorks

Introducing the Lumella GlyFN Point-of Care TestN

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Measures glycosylated fibronectin (GlyFN)

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Uses 5 µL finger prick blood sample

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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