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  1. Oncology Center of Excellence

Precision Oncology Program

Precision Oncology

Precision in Oncology 

Precision oncology leads to customization of healthcare, with medical decisions, practices and products being tailored to each individual patient with cancer. In oncology drug, biologic, and device development, more precise targeting of a product to an individual’s genomic, proteomic, metabolomic make-up will likely lead to more effective and less toxic anti-cancer therapies.

The Oncology Center of Excellence (OCE), charged with integrating the expertise of the product centers to advance care for patients with cancer, is uniquely situated to develop the methodologies to advance Precision Oncology. The focus of the Precision Oncology Program will be to coordinate and integrate efforts across the centers to:

  1. Educate FDA staff on the state of the science and cutting-edge research in precision oncology.
  2. Interface with the public and key external stakeholders and educate the public regarding FDA’s role in the advancement of precision oncology.
  3. Catalyze regulatory science research and development to apply new methodologies to deliver the promise of precision oncology for new and better drugs, diagnostics, and biologics to reduce the burden of cancer.

Companion Diagnostics 

A  companion diagnostic 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. 

Companion diagnostics can:

•    identify patients who are most likely to benefit from a particular therapeutic product,
•    identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product, or
•    monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness.

If the diagnostic test is inaccurate, then the treatment decision based on that test may not be optimal.

For the list of cleared or approved companion diagnostic devices, visit List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)

Oncology Diagnostic Pilot 

The FDA issued a final guidance, “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” in June 2023, to announce and describe the FDA’s voluntary pilot program for certain CDER-regulated oncology drug products used with certain in vitro diagnostic tests. For additional information on this pilot program, visit the Pilot Program landing page

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