Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that the manufacturing of Quidel Triage® PLGF Test is set to resume in 2019 and be commercially available outside the US for clinical use in Q1 2019. Knowledge of maternal circulating concentration of Placental Growth Factor (PLGF), a biomarker for placental dysfunction, aids in the early and accurate diagnosis of preterm pre-eclampsia and helps clinicians to accurately risk-stratify pregnant women resulting in more efficient use of healthcare resources and the potential for cost-saving to the healthcare system.
In Quidel’s acquisition of the Triage® business from Alere Inc., ownership of the Triage PLGF product, together with the continued supply of product into key clinical studies, transferred to Quidel. Quidel has completed an internal review of unmet clinical needs in the management of pre-eclampsia and the strength of clinical evidence and has concluded that Quidel Triage PLGF Test is a competitive and medically necessary diagnostic test.
Current antenatal detection of pre-eclampsia relies on clinical markers, blood pressure and urinalysis for protein, which have low sensitivity and specificity, and poor prognostic ability. A low PLGF concentration in the maternal circulation identifies pregnancies likely to develop placentally-driven complications, such as preterm pre-eclampsia and fetal growth restriction. In May 2016, the UK National Institute for Health and Care Excellence (NICE) developed a national guidance for NHS England on PLGF-based testing1 to help clinicians diagnose pre-eclampsia in women suspected of having the condition. NICE recommends the use of PLGF-based tests, including Triage PLGF, to help rule-out pre-eclampsia in pregnant women who are between 20 weeks and 34 weeks plus 6 days’ gestation and have signs or symptoms of pre-eclampsia.
Uniquely, Quidel’s PLGF measurements are performed on the Quidel Triage MeterPro, a small low-cost benchtop analyzer that enables near patient testing and provides results in about 15 minutes. Quidel Triage MeterPro can connect to laboratory information systems and has built-in quality control features. Quidel’s MeterPro platform offers end-users a more cost-efficient and expedient testing platform than central laboratory analyzers.
“We are happy to re-introduce Quidel Triage PLGF into the marketplace, thereby assisting healthcare workers in ruling out pre-eclampsia, and protecting our most vulnerable patients,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “Longer term, we believe that clinicians will find that the test has additional clinical value in evaluating placental health.”