PerkinElmer Gains FDA Nod for Newborn Screening Test
The automated GSP system enables multianalyte analysis for metabolic diseases.
PerkinElmer received 510K clearance from the FDA for GSP™ - Genetic Screening Processor, which will be used as part of newborn screening programs. The system is an automated platform that quantitatively and qualitatively analyzes blood spot samples for irregularities associated with metabolic diseases.
PerkinElmer reports that the GSP Neonatal TSH assay is the first such assay to receive FDA approval. Several additional newborn screening assays are in development.
The GPS platform allows labs to run more than one test simultaneously on very small blood samples. This multianalyte capability also preserves the small sample volume for a wider range of analysis. Additionally, the processor has the ability to run traditional immunoassays or enzymatic assays.
With multianalyte capabilities and a twofold capacity over prior systems, it delivers increased efficiency and flexibility over other methods while reducing the risk of errors associated with manual processing of samples, PerkinElmer points out. Additionally, the GSP analyzer eliminates the need to analyze samples in batches, permitting specimens to be processed as they arrive in the laboratory.
The GSP performs each stage of the assay process, from the retrieval of the sample plate to sample measurement and reporting of results, in a single platform. This improves operational efficiency and reduces hands-on time, according to PerkinElmer. Results are also barcoded, decreasing the risk of human error.
Other design features that address common laboratory challenges include the ability to continuously load samples, refrigeration of onboard reagents, and integration of direct access to water and waste lines.