Health Canada Approves QuidelOrtho’s Triage PLFG Test for Lab Use

QuidelOrtho Corporation has received Health Canada approval for its Triage PLGF test for laboratory use. The Triage PLGF test is a fluorescence immunoassay to be used with the small footprint Triage MeterPro Instrument to help measure placental growth factor (PLGF) in maternal plasma specimens. The test is intended to detect the presence of angiogenic imbalance, a consequence of abnormal placentation and poor blood flow in the placenta, which can lead to maternal and fetal complications of pregnancy, including pre-eclampsia.¹
 
Pre-eclampsia is a serious disorder that affects up to 5% of pregnancies in Canada.² The Triage PLGF test is used with other clinical information to help doctors diagnose preterm pre-eclampsia and provide a prognosis of short-term delivery in women presenting with signs and symptoms of pre-eclampsia between 20 and 35 weeks’ gestation. A pre-eclampsia diagnosis indicates delivery within 14 days.³
 
“When signs or symptoms of pre-eclampsia are present, it is critical to the health and safety of the mother and her unborn baby that clinicians have the information necessary to determine the optimal course of action to achieve the best possible outcome for the pregnancy,” said Bernard Michaud, country director, Canada, at QuidelOrtho. “The Triage PLGF test is intended to help clinicians diagnose pre-eclampsia sooner and may provide them with information on whether the pregnancy is likely to deteriorate within the next 14 days, allowing for a better patient care management plan.”
 
Angiogenic imbalance plays a central role in the pathophysiology of preterm pre-eclampsia and places the pregnancy at risk for maternal complications, like HELLP syndrome and eclampsia, and fetal complications, such as prematurity and stillbirth. With the Triage PLGF test, clinicians can be positioned to better detect angiogenic imbalance and assess the risk for these complications. The Society of Obstetricians and Gynecologists of Canada (SOGC) guidelines indicate the measurement of angiogenic markers, such as those detected by the Triage PLGF test, due to strong clinical evidence supporting their use to better diagnose pre-eclampsia and provide a prognosis for adverse pregnancy outcomes.⁴
 
The Triage PLGF test delivers results in approximately 15 minutes and provides high accuracy to support a pre-eclampsia diagnosis. When integrated into a clinical management guideline, the Triage PLGF test can lead to faster diagnosis and a 20% reduction in maternal adverse outcomes.⁵ The Triage PLGF test measures a single biomarker on the Triage MeterPro instrument, unlike other tests which require two biomarkers measured on a larger-footprint laboratory analyzer. The Triage PLGF test is available to customers in Canada for use with the Triage MeterPro instrument. 
 
QuidelOrtho Corporation develops and manufactures in-vitro diagnostics solutions that transform data into understanding and action. The company offers expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine to bring fast, accurate and reliable diagnostics when and where they are needed – from home to hospital, lab to clinic. Building upon its years of innovation, QuidelOrtho continues to partner with customers across the healthcare continuum and worldwide to forge a new diagnostic frontier.

References
¹ Redman CWG, Sargent IL. Pre-eclampsia, the placenta and the maternal systemic inflammatory response—a review. Placenta. 2003;24 Suppl A:S21-7. doi:10.1053/plac.2002.0930
² Ontario Health (Quality). Placental growth factor (PLGF)-based biomarker testing to help diagnose pre-eclampsia in people with suspected pre-eclampsia: A health technology assessment. Ont Health Technol Assess Ser. 2023;23(3):1-146.
³ Quidel Triage PLGF Pack Insert
⁴ Magee LA, Smith GN, Bloch C, et al. Guideline No. 426: Hypertensive disorders of pregnancy: Diagnosis, prediction, prevention, and management. J Obstet Gynaecol Can. 2022;44(5):547-571.e1. doi:10.1016/j.jogc.2022.03.002. PMID: 35577426
⁵ Duhig KE, Myers J, Seed PT, et al. Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial. Lancet. 2019;393(10183):1807-18. doi:10.1016/S0140-6736(18)33212-4