Luminex Corp. announced today that it has received CE marking of both the xMAP NeoPlex4 Assay and NeoPlex System. This system represents a change in the way newborn screening is performed, providing four assays from one blood spot punch, reducing sample requirements and improving laboratory efficiency, the company says. 

The NeoPlex4 Assay simultaneously tests four analytes, T4, TSH, 17OHP, and total IRT, which can be indicators of congenital hypothyroidism, congenital adrenal hyperplasia, and cystic fibrosis. 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. With a growing number of laboratories screening for more disorders, testing efficiently and using only a small amount of sample is increasingly important, Luminex says.

 

"Our revolutionary approach provides important benefits to both laboratories and patients," said Greg Gosch, vice president, Immunodiagnostics at Luminex. "In a study comparing the NeoPlex System to current methods, the NeoPlex System can reduce laboratory labor time up to 60%. Additionally, with our unique multiplexing technology, we have the ability to add more analytes over time as the need for new assays emerges." 

 

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 system 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. 

 

Further information is available in the Luminex press release.