FDA Issues New Draft Guidance on Medical Diagnostics Tests

Federal drug regulators have issued new guidelines on the development of companion diagnostics, to help healthcare professionals diagnose and treat patients more accurately. 

The final guidance for companion diagnostics (PDF) set forth by the FDA on July 31 are designed to allow healthcare professionals to tailor medical and therapeutic treatments to an individual’s needs.

With advances in personalized medicine, doctors and physicians will be able to evaluate particular drugs and drug therapy programs to customize an individual’s best course of action by using companion diagnostics.

Companion diagnostics are medical devices that help doctors decide which treatments to offer patients and which dosage of certain medications should be taken. The tests are designed to be paired with a specific drug by the drug and device manufacturers as well as FDA experts. These tests then go through extensive trials before and an approval and clearance stage before ever being tested in clinical trials.

The FDA also hopes that issuing the final guidance on the development, review, and approval or clearance of companion diagnostics will help companies identify the need for these tests earlier in the drug and device development process. The FDA’s goal is to collaborate with the developers in the early stages to help achieve a better result and faster access to promising new treatments for patients who have life-threatening diseases.

FDA’s Medical Officer in the Division of Oncology, Patricia Keegan, explained that advancement in companion diagnostic testing will allow doctors to recognize alternative methods of treatment for conditions that may be more suitable and beneficial to patients. For example, the FDA stated with the use of diagnostic testing an individual with a condition caused by a mutation in their genes can be prescribed a medication that targets that specific mutation because the doctors will be able to identify the mutation.

FDA Commissioner Margaret A. Hamburg, M.D. is encouraging the advancement in personalized medicine by using companion diagnostic testing claiming that doctors and patients must have access the safe, accurate, and reliable testing to choose appropriate treatments.

“Inaccurate test results can cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether,” Hamburg said.

Diagnostic tests have been used for many years to enhance the use of therapeutic products. Tests are also used during therapeutic product development to obtain the data FDA uses to make regulatory determinations. Currently, the FDA has cleared 19 companion diagnostic tests for selection of drugs to treat various diseases and conditions.