QuidelOrtho Receives Health Canada Approval for Quidel® Triage® PLGF Test for Laboratory Use in Canada
06 Marzo 2024 - 3:35PM
Business Wire
Aiding in the diagnosis of preterm
pre-eclampsia and prognosis of delivery in symptomatic
women
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 PLGF test
for laboratory use in Canada. The Triage PLGF test is a
fluorescence immunoassay to be used with the small footprint Triage
MeterPro® Instrument for the quantitative determination of
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 percent
of pregnancies in Canada.2 The Triage PLGF 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 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, like 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, 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 PLGF 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 PLGF
test can lead to faster diagnosis and a 20% reduction in maternal
adverse outcomes.5 The Triage PLGF 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 PLGF 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 PLGF 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.
Source: QuidelOrtho Corporation
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Investor Contact: Juliet Cunningham Vice President, Investor
Relations IR@QuidelOrtho.com
Media Contact: Stephanie Kleewein Communications Manager
media@QuidelOrtho.com
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