Prenatal screening assays gain approval of Foetal Medicine Foundation for the detection of Down's through nuchal translucency with or without maternal serum biochemistry
PerkinElmer reports that its Delfia Xpress first trimester prenatal screening assays have been approved by the Foetal Medicine Foundation (FMF), London, UK.
The approval of the assays makes them available in Europe for FMF-certified laboratories and FMF-certified clinicians for the detection of Down's Syndrome.
The Foetal Medicine Foundation is a registered charity that promotes research and training in fetal medicine.
FMF is widely respected globally and has established a standard for first trimester screening which embraces the role of clinicians, laboratories and the assays that are used.
FMF promotes first trimester screening for Down's Syndrome through nuchal translucency, or a combination of nuchal translucency and maternal serum biochemistry.
The combination of nuchal translucency and assay of maternal serum free hCGB and PAPP-A improves the detection of affected foetuses.
Extensive prospective studies have reported that for a 5% false positive rate, the detection rates of trisomy 21 are 85-90% for combined screening, compared to 75% for ultrasound alone.
"This approval represents an important endorsement of PerkinElmer's Delfia technology," said Peter Coggins, president of PerkinElmer Life and Analytical Sciences.
"To be recognised by the Foetal Medicine Foundation means that PerkinElmer has successfully demonstrated our common commitment to prenatal screening, and that our assays meet their strict criteria to be used in FMF certified laboratories".
The approval covers assays for PAPP-A and free hCGB run on PerkinElmer's Delfia Xpress random access platform.
The system is designed to meet the needs of clinics and laboratories for fast delivery of reliable test results.
Delfia is a heterogeneous time-resolved fluorometric assay method in which an enhancement step assures high sensitivity and wide response range.
The company's Delfia manual assays and Autodelfia batch automation assays were approved by FMF some time ago.
To obtain FMF approval, PerkinElmer was required to provide clinical data to prove the clinical validity of the assays, to demonstrate a commitment to prenatal screening, and to provide evidence of the successful use of assays in respected international studies.
