Luminex, a developer of diagnostic instruments, has obtained CE mark approval for its newborn screening platform including xMAP NeoPlex4 sssay and NeoPlex system.
The NeoPlex system, an automated, walk-away sample processing instrument, provides four assays which simultaneously test T4, TSH, 17OHP and total IRT analytes from single blood spot sample.
The T4, TSH, 17OHP and total IRT analytes can be indicators of congenital hypothyroidism, congenital adrenal hyperplasia and cystic fibrosis.
Luminex president and chief executive officer Patrick Balthrop said, "The ability to provide more data with less sample saves precious time and resources for clinical lab professionals and allows affected infants to be identified more quickly."
Luminex Immunodiagnostics vice president Greg Gosch said 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," Gosch added.