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On the near horizon
Regular patient screening for Phenylketonuria
The first FDA-approved prescription medication that reduces blood phenylalanine (Phe) levels in patients with Phenylketonuria (PKU) — a genetic disorder that prevents the normal use of protein foods and can lead to impaired brain development if untreated — could result in more regular screening of blood phenylalanine (Phe) levels in PKU patients.
Biochrom Ltd, based in Cambridge, UK, reports that it is ready to provide both the necessary screening instrumentation and the PKU diagnostic reagents. ‘The Biochrom 30 Physiological is a compact bench-top instrument designed for metabolic disorder screening and research applications. The instrument’s Lithium High Performance Columns perform a full routine analysis of physiological fluids, enabling the determination of up to 53 different amino acids, including physiologically important amino acids for early detection of hereditary metabolic disorders and the effectiveness of nutrient absorption. The Biochrom 30 Physiological incorporates customised load and go applications for simplicity of operation, and the instrument’s software supports a graphical user interface that fully integrates instrument control and data handling functions and provides flexible data export and customised reporting,’ the company explains.
‘The IVD (In Vitro Diagnostic) Directive requires that equipment and reagents used for the in vitro diagnosis of PKU are subject to stringent quality controls, certified by an external, notified body. Biochrom was the first Amino Acid Analyser manufacturer to achieve this certification for its PKU diagnostic reagents from the UK notified body, LRQA (Lloyds Register Quality Assurance), as part of the company’s approval under the new ISO 13485:2003 standard,’ explained Sally Bee, Biochrom’s Amino Acid Analysis Marketing Manager.
Details: www.biochrom.co.uk
This article was published on 04/30/2008