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;
    • Determining:
      • 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.

Contact

+33 1 60 08 43 85
+33 1 60 08 00 22

24 Rue Gambetta 77400 LAGNY-SUR-MARNE, France