Why do you need to develop CDx for your therapeutic?

  • Pharmacological clinical trials with patient selection as part of the inclusion/exclusion criteria and may need an investigational in vitro diagnostic (IVD) medical device for medical management decisions. A CDx can screen specific biomarkers and identify patients that are likely to respond to the therapy or patients that are at increased risk for adverse events.
  • Including a CDx in your precision medicine strategy can increases the likelihood of a positive response and better clinical outcomes, as the CDx can match the right patients with the right treatment. The use of a CDx to pre-screen and select patients for clinical trials can lead to more efficient trials as the trial population is more targeted, possibly reducing the cost and shortening timelines.