QuidelOrtho Gets Health Canada Approval for Triage Preeclampsia Test

Original from: 360dx

QuidelOrtho announced Wednesday that it has received approval from Health Canada to market the firm's Triage PLGF test. The test detects a biomarker that can indicate the likelihood of a pregnant person developing preterm preeclampsia.

The Triage PLGF test is a fluorescence immunoassay for laboratory use with the Triage MeterPro instrument, the San Diego-based firm said in a statement. The 15-minute quantitative test measures placental growth factor, or PLGF, in maternal blood plasma samples. QuidelOrtho acquired the PLGF test when it bought the Triage business from Alere in 2017. 

The test detects an imbalance in the formation of new blood vessels that results from abnormal growth and blood supply to the placenta, QuidelOrtho said. Furthermore, it uses a small-footprint instrument to detect a single biomarker, while other commercially available tests use larger instruments and measure two biomarkers in similar assays. 

Preeclampsia can be diagnosed between 21 and 34 weeks of gestation and indicates delivery within 14 days. The condition affects approximately 5 percent of pregnancies in Canada, and Society of Obstetricians and Gynecologists of Canada guidelines suggest measuring angiogenic markers, QuidelOrtho said. The Triage PLGF test has also been incorporated into UK guidelines for preeclampsia screening along with tests from Roche, Thermo Fisher Scientific, and Revvity.

"The Triage PLGF test is intended to help clinicians diagnose preeclampsia 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," said Bernard Michaud, country director for Canada at QuidelOrtho. 

In 2023, a test from Thermo Fisher Scientific that measures PLGF and soluble fms-like tyrosine kinase 1 (sFlt1) became the first preeclampsia screening immunoassay to obtain clearance from the US Food and Drug Administration. In February, the Foundation for the National Institutes of Health said it will partner with eight organizations on a three-year project to evaluate the prognostic value of placental growth factor as well as a biomarker called pregnancy-associated plasma protein-A as indicators of preeclampsia risk during the first trimester of pregnancy.​

Source: QuidelOrtho Gets Health Canada Approval for Triage Preeclampsia Test