Quidel Announces the Availability of Triage® PLGF Assay for Use with Quidel’s Triage® MeterPro Instrumented System
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.”
Quidel’s Triage PLGF product is currently CE Marked, and only available for sale outside the United States.
1 PLGF-based testing to help diagnose suspected pre-eclampsia (Triage PLGF test, Elecsys immunoassay sFlt-1/PLGF ratio, DELFIA Xpress PLGF 1-2-3 test, and BRAHMS sFlt-1 Kryptor/BRAHMS PlGF plus Kryptor PE ratio). National Institute for Health and Care Excellence (NICE) Diagnostics guidance [DG23] Published date: May 2016.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's recently acquired Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio, visit quidel.com.
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