Development and Use of Diagnostic Testing

Bryan Loy, MD, discusses how the FDA approval process for emerging diagnostic tests is becoming more rigorous and well defined. He notes that this guidance should be of help in theplanning stages of test development. Dr Loy explains that many of these tests are being developed in the laboratory industry rather than the pharmaceutical industry. He insists that innovation should not be stifled, and that it is in everyone’s interest to move tests quickly through the approval process to market while ensuring their validity.

Dr Loy is uncertain about how well providers really understand the development process, or in some cases, even the quality, the analytic validity, and the methodology of those tests. Therefore, adoption will be based on a variety of factors including price point, accessibility, decentralization, interpretability of the information, ease of doing business, and ability to return results fast enough to avoid delaying therapy.