IVD & Companion Diagnostic Test
Diagnostic tests improve patient management and allow better control of health costs. They are a public health interest.
Companion diagnostic testing allows selecting by predictive marker identification only patients likely to receive a benefit from a so-called targeted therapy.
WHITE-TILLET advises and assists you to:
- Establish a development plan for:
- Defining an analytical plan, the sensitivity and specificity of the tests;
- The predictive positive and negative values;
- The Receiver Operating Characteristic (ROC) curve.
- The Likelihood Ratio (LR);
- To evaluate the clinical validity and clinical usefulness
- The CE marking procedure
Tillet Y, Breysse A, Dreyfuss T, Dubos C, Lewellen O, Rath-Lavialle A, Tillet A, Yang M, Zerial A. Personalized medicines and pharmacogenomic testing: from scientific basis to assessment, regulatory framework, labelling, and practical information. Gazette de l’AFAR, 2016. In press.
24 Rue Gambetta 77400 LAGNY-SUR-MARNE, France