Mesothelin-ADC - Molecular Diagnostics for Cancer Drug ...
Mesothelin-ADC - Molecular Diagnostics for Cancer Drug ...
Mesothelin-ADC - Molecular Diagnostics for Cancer Drug ...
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Companion <strong>Diagnostics</strong> in Practice<br />
Implementation requires validated tests – EU<br />
• <strong>Drug</strong> and Diagnostic applications are registered<br />
separately in the EU<br />
• <strong>Drug</strong>s are reviewed by the CHMP and approved by<br />
the EU Commission.<br />
• <strong>Diagnostics</strong> come under the purview of National<br />
Competent Authorities and are either self-declared<br />
or are approved by Notified Bodies<br />
• IVDs not reviewed by the EMA, but reflection<br />
paper in preparation<br />
• regulated by European Directive 98/97/EC<br />
“In vitro diagnostic medical devices”<br />
(currently under revision - new version in 2012)<br />
• CE marking applies directly to all countries<br />
recognizing the classification; Instrument,<br />
Primary antibody, detection system are CE<br />
marked separately<br />
12 • <strong>Mesothelin</strong> <strong>ADC</strong> • Boston, June 2012 • David Henderson
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