Luminex Corp has received CE marking of both the xMAP NeoPlex4 Assay and NeoPlex® System. This unique system changes the way newborn screening is performed, providing four assays from one blood spot punch, reducing sample requirements and improving laboratory efficiency.

Millions of infants have blood drawn from their heel after birth to detect rare disorders that could threaten their life and long-term health. For most of these disorders, there is no medical history of the condition in the family and no way to predict the health of a baby based on the health of the parents. Early screening, diagnosis, and proper treatment can decrease newborn morbidity and mortality and improve the infant’s quality of life and life expectancy.

The NeoPlex4 Assay simultaneously tests four analytes, T4, TSH, 17OHP, and total IRT, which can be indicators of congenital hypothyroidism (CH), congenital adrenal hyperplasia (CAH), and cystic fibrosis (CF phenotypic). Each of these conditions can cause severe mental and physical disability if untreated. If detected early through testing, effective treatment can be initiated. Multiplexing these tests together from one blood spot punch offers significant improvements in testing efficiency to newborn screening laboratories around the world. With a growing number of laboratories screening for more disorders, testing efficiently and using only a small amount of sample is increasingly important.

The NeoPlex System is Luminex’s first fully automated, walk-away sample processing instrument. The system generates approximately 3,000 results per day. The NeoPlex4 Assay and NeoPlex System are part of a growing total solution Luminex provides for newborn testing labs. Additional products include Luminex’s BSD 300 Semi-Automated Punch System, which provides a front-end automated punching process for dried blood spots prior to analysis, and recently introduced CardScan™ which helps nurses and midwives analyze blood spots for accuracy prior to sending them for screening and aids the newborn screening lab by selecting the best punch before testing.

Source: Luminex Corp