CONSULTANT CONNECTION – CDx GOES BEYOND ONCOLOGY
The goal of personalized medicine is to maximize the likelihood of therapeutic efficacy while minimizing the risk of drug toxicity for an individual patient, and CDx epitomizes that approach.

Until now, the vast majority of FDA-approved CDx have been in the support of oncology therapeutics. Developers in this therapeutic area have become more adept at navigating its complexity, understanding its special considerations and recognizing the need for deep technical expertise when managing an in vitro diagnostic (IVD) or laboratory developed test (LDT) development program. These have given rise to new advances, like immuno-oncology, giving patients important, new options for safe, effective, personalized medicine. 

Most compounds progressing through clinical development today are targeted biologics driven by advances in genetics that make it possible to identify markers previously unknown. In addition, there are economic advantages to biologic development. Nearly 50% of all compounds in clinical development are dropped for lack of efficacy. CDx represents a way to potentially improve the odds of drug development success.

As a result, drug developers are differentiating themselves by setting CDx strategies earlier and for indications beyond oncology. Emerging areas include women’s health, where a CDx was recently implemented to personalize dosing in a new treatment for patients undergoing in vitro fertilization. The therapy went on to become the first non-oncology CDx to receive CE marking. 


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Explore more ways to advance your client's programs:
As a consultant, it’s important to know that there are multiple CDx assays and platforms to consider as there are opportunities. You can prepare your clients by:
Covance CDx Lab
It’s not just for oncology anymore. That’s the headline coming from precision medicine experts regarding companion and complementary diagnostics (CDx) – and it’s gotten the attention of smaller and emerging biotechs. 

Why? Programs that use selection biomarkers are three times more likely to gain Phase I approval than those that did not. Further, rare disease programs and those that use selection biomarkers have higher success rates at all phases of development.
Alzheimer’s Disease is another area with significant potential for CDx incorporation, thanks to advances in genetic testing that help identify those at higher risk earlier in the disease progression. Click here to learn more about how a CDx recently aided in the development of a cerebral spinal fluid IVD diagnostic panel to identify patients with early indications of both mild cognitive impairment and full-blown disease.

Beyond these two examples, CDx may play an important role in areas such as immunology and rare and orphan diseases.

Pursuing a CDx can be a complex endeavor. It requires a comprehensive understanding of clinical trial design, regulatory submission strategies both for the therapy and the diagnostic assay, and also a line of sight for successful commercialization. 

Learn more about how Covance can help you provide your client the best chance of success through our experience and expertise taking a CDx from bench to bedside. 
  • Helping them to understand the benefits of the current IVD and LDT development models for CDx, and how to promote strong partnerships with key co-development stakeholders
  • Developing a sound CDx strategy that enables enhanced trial design and execution and looks ahead to prepare for critical regulatory and commercial considerations
  • Working with an experienced partner who has familiarity with a range of technology platforms and brings proven experience in a variety of therapeutic areas