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Luminex Corporation Receives CE Mark for Newborn Screening Platform

Texas Business reports:  AUSTIN—Luminex Corporation received CE marking of both the xMAP NeoPlex4 Assay and NeoPlex System.

 The newborn screening system provides four assays from one blood spot punch, reducing sample requirements and improving laboratory efficiency.

The CE marking is a mandatory conformity mark for products placed on the market in the European Economic Area (EEA). Products to be sold in the European Union (EU) that come under certain European Directives must bear the CE mark – it is a legal requirement.

Millions of infants have blood drawn from their heel after birth to detect rare disorders. 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, mortality and improve the infant's quality of life and life expectancy.

“Launch of the NeoPlex4 Assay and NeoPlex System in Europe represents a significant milestone and complements our portfolio of blood spot automation products currently used in most newborn screening laboratories," said Patrick J. Balthrop, president and chief executive officer of Luminex.  “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.  We are pleased to provide new approaches to protecting the lives of newborns as part of our mission to advance healthcare worldwide.”

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.

“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 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.