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Gene chip firms to follow premarket route in US

This article was originally published in Clinica

Executive Summary

Companies with diagnostic gene chips under development will not qualify for the lenient rules the FDA accords many single analyte tests. Instead, these microarrays that test multiple analytes will have to go through US FDA's premarket review programme before they can be marketed, agency officials disclosed last week at the annual meeting of the Association of Medical Diagnostic Manufacturers (AMDM).

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