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Luminex wins CE mark for newborn screening platform

30 April 2012

Luminex has received CE mark approval for its newborn screening solutions, xMAP NeoPlex4 assay and NeoPlex system.

The NeoPlex system is an automated, walk-away sample processing instrument which provides four assays from single blood spot sample, reducing sample requirements and improving laboratory efficiency.

NeoPlex4 simultaneously tests T4, TSH, 17OHP and total IRT analytes which can be indicators of congenital hypothyroidism (CH), congenital adrenal hyperplasia (CAH) and cystic fibrosis (CF phenotypic).

Patrick Balthrop, Luminex president and chief executive officer, said the launch of the NeoPlex4 assay and NeoPlex system in Europe complements the company's portfolio of blood spot automation products currently used in newborn screening laboratories.

"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," Balthrop added.

Luminex Immunodiagnostics vice president Greg Gosch said in a study comparing the system to current methods, the NeoPlex was found to reduce laboratory labour 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 company's product line also includes a BSD 300 semi-automated punch system, which provides a front-end automated punching process for dried blood spots prior to analysis, and CardScan, which helps nurses and midwives analyse blood spots for accuracy prior to sending them for screening.

Luminex is focused on the development, manufacturing, and marketing of proprietary instruments and assays utilising its xMAP open-architecture, multi-analyte platform, MultiCode real-time polymerase chain reaction (PCR) and multiplex PCR-based technologies.