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A Guide to accelerating the development and commercialization of Precision Medicine Diagnostics

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A Companion Diagnostic (CDx) is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product.

The use of a CDx with a particular therapeutic product is stipulated in the instructions for use, within the labeling of both the diagnostic device and the corresponding therapeutic product, as well as in the labeling of any generic equivalents and biosimilar equivalents of the therapeutic product.

A CDx biomarker test is used to identify patients who are more likely to respond to a given targeted therapy by predicting that the patient:

  • What is Precision Medicine?
  • What is a Biomarker?
  • What is a Companion Diagnostic (CDx)?
  • What Form Can a CDx Take?
  • Development of Precision Medicines and Companion Diagnostics Happens Simultaneously
  • The Six Barriers to Testing Adoption
  • How to Increase the Chances of Sufficient Reimbursement for Your CDx Test
  • Glossary of Precision Medicine Terms

What you will learn:

DXRX - The world's first Diagnostic Network

An end-to-end solution for the development and commercialization of precision medicine diagnostics

Learn More about DXRX

At Diaceutics we believe that every patient should get the precision medicine they deserve. We are a data analytics and end-to-end services provider enabled by DXRX - the world’s first Network solution for the development and commercialization of precision medicine diagnostics. Diaceutics has worked on every precision medicine brought to market and provides services to 36 of the world’s leading pharmaceutical companies. We have built the world’s largest repository of diagnostic testing data with a growing network of 2500 labs in 51 countries.

About Diaceutics

What is a Companion Diagnostic?

Companion Diagnostics 101

This Figure shows two patient pathways. On the left, the pathway depicts the established paradigm of cancer treatment in which one therapy is used for all patients. On the right, the pathway depicts the use of biomarker testing in order to segment the patient population based on the likelihood of response due to the biomarker test result.

  • Is likely to respond to the therapy (eg, EGFR in non–small cell lung cancer [NSCLC]),
  • Is unlikely to respond to the therapy (eg, KRAS in colorectal cancer [CRC]) or Does not need to be on therapy (eg, BCR-ABL in chronic myeloid leukemia [CML]).

Patient Pathway: With or Without CDx Guidance

The Companion Diagnostics 101 Report is an industry expert's introduction for professionals working in the development and commercialization of Precision Medicine diagnostics.

View the report to get a comprehensive insight into the role of Companion Diagnostics in Precision Medicine and understand some of the key concepts, principles and terminology essential to the rollout of a successful commercial therapy launch.

View the Companion Diagnostics 101 Report now