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Members' Press Releases

From the monthly archives: March, 2016

We are pleased to present below all posts archived in 'March, 2016'. If you still can't find what you are looking for, try using the search box.

Are IVD Medical Device companies ready for the challenge of meeting new EU regulatory legislation?

Real Life Sciences

The introduction of new EU regulatory legislation is likely to have a major impact on In Vitro Diagnostic (IVD) manufacturers as they meet new external EU compliance requirements. Currently 80% of all IVD devices on the market in the EU meet self-certified compliance requirements but new EU legislation means they will have to meet rules based on classifications set by the Global Harmonization Task Force.

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Automated Faecal Immunochemical Testing

Alpha Laboratories

Quantitative Faecal Immunochemical Testing (FIT) demonstrates greater sensitivity and specificity for faecal haemoglobin (f-Hb) than guaiac based tests. Increased concentrations off-Hb are indicative of greater risk of pathology for cancers and high risk adenomas. The Kyowa Medex HM-JACKarc, available exclusively in the UK from Alpha Laboratories, is an automated FIT system suitable for both screening and symptomatic patient assessment. It includes a state of the art automated analyser, a bespoke faecal sample tube and dedicated, sensitive, latex agglutination reagents. This combination provides a convenient, high throughput solution for the detection and quantification of faecal occult blood.

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