Prevention magazine selected EndoPAT among top medical breakthroughs

Drug-Diagnostic

Co-Development Programs

 

A companion diagnostic is a device or technology that is used to predict whether a targeted drug therapy will work effectively during preclinical development, and is often used after the drug has received approval to assess its actual effectiveness in a given population.

Utilizing their world renowned EndoPAT device for monitoring endothelial function, Itamar develops companion diagnostic products to support drug discovery and development from inception straight through to regulatory approval and launch. 

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Itamar Work Package

Itamar offers a specialized program for each drug and diagnostic project and includes elements of the following:

  • Consultancy and advice on developing a companion diagnostic utilizing EndoPAT technology to support testing of targeted therapies
  • Study design and development
  • Lease of EndoPAT technology for the length of the study
  • On-site staff training
  • Core lab for EndoPAT analysis
  • Investigational use of EndoPAT devices for multi-site clinical trials
  • Full technical support
  • Regulatory support
  • Management provided by a dedicated Project Team Leader (M.D.)

Why Partner With Itamar?

 

 

 

 

 

 

 

 

Itamar is a world leader 

in proven companion diagnostic 

solutions for the pharmaceutical industry.

 

 

 

 

 


For further information about Itamar’s companion diagnostic development programs

contact us

Proven Leadership

Itamar is the world leader in endothelial function companion diagnostics.

Regulatory Experience

Pharmacovigilance regulatory requirements for optimal protection of patients in clinical trials have added an extra layer to drug development.

Itamar has proven experience working with drug companies and regulatory bodies—including the U.S. Food and Drug Administration—to develop companion diagnostics and gain regulatory approval. Itamar works with the drug company and regulatory authorities to ensure the test is approved as a companion diagnostic to support the sales of the new drug.

Technology

Itamar’s EndoPAT technology can be used in multiple platform settings.

Independence

Itamar is an independent company that works with many pharmaceutical companies on their companion diagnostic projects. Itamar ensures strict confidentiality with all of its partners.

Cost Savings And Shortened Development Time

By using EndoPAT testing as a surrogate marker for drug “success,” this eliminates useless latter-stage testing on patients who will not benefit and use only those who will. This also allows pharma to bring the data on “failed” patients back into the preclinical development cycle to find a treatment that will work.

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