QuidelOrtho receives Health Canada approval for Quidel^® Triage^® P_LFG test for laboratory use in Canada

SAN DIEGO, CA — March 6, 2024 — QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received approval from Health Canada for its Triage P_LGF test for laboratory use in Canada. The Triage P_LGF test is a fluorescence immunoassay to be used with the small footprint Triage MeterPro^® Instrument for the quantitative determination of placental growth factor (“P_LGF”) 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 percent of pregnancies in Canada. ² The Triage P_LGF test is used with other clinical information to aid in the diagnosis of preterm pre-eclampsia and in the prognosis of short-term delivery in women presenting with signs and symptoms of pre-eclampsia after 20 weeks and prior to 35 weeks of gestation. Diagnosis of pre-eclampsia 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 P_LGF 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, like prematurity and stillbirth. With the Triage P_LGF 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 P_LGF test, because of strong clinical evidence supporting their use to aid in the diagnosis of pre-eclampsia and prognosis for adverse pregnancy outcomes.⁴

The Triage P_LGF test delivers results in approximately 15 minutes and provides high accuracy to support the clinical diagnosis of pre-eclampsia needing delivery within 14 days. When integrated into a clinical management guideline, the Triage P_LGF test can lead to faster diagnosis and a 20% reduction in maternal adverse outcomes. ⁵The Triage P_LGF test is unique because it 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 P_LGF test is available to customers in Canada for use with the Triage MeterPro instrument. The Triage MeterPro instrument is easy to use with robust quality control and would be suitable for urban and rural laboratory settings, delivering Triage P_LGF test results quickly.

Resources:

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

About QuidelOrtho Corporation

QuidelOrtho Corporation (Nasdaq: QDEL) is a world leader in in vitro diagnostics, developing and manufacturing intelligent solutions that transform data into understanding and action for more people in more places every day.

Offering industry-leading expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, bringing fast, accurate and reliable diagnostics when and where they are needed – from home to hospital, lab to clinic. So that patients, clinicians and health officials can spot trends sooner, respond quicker and chart the course ahead with accuracy and confidence.

Building upon its many years of groundbreaking innovation, QuidelOrtho continues to partner with customers across the healthcare continuum and around the globe to forge a new diagnostic frontier. One where insights and solutions know no bounds, expertise seamlessly connects and a more informed path is illuminated for each of us.

QuidelOrtho is advancing diagnostics to power a healthier future.

For more information, please visit www.quidelortho.com.