In a landmark decision, FDA on June 20th, 2023 launched a new pilot program to mitigate the risks involved with certain Laboratory Developed Tests (LDTs) used to develop certain oncology products. It is an important initiative by FDA to address the safety standards associated with unregulated or poorly performing in vitro diagnostic tests. With an aim to make a straightforward performance recommendation for laboratory-developed tests for cancer biomarkers, FDA’s pilot program may extend up to one year, during which FDA plans to evaluate up to nine drug sponsors. The LDTs associated with each approved drug product will be available on FDA’s official website.
What is this Program?
1. The FDA has launched a new pilot program for oncology drug products and in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients.
2. The program aims to reduce the risk of using LDTs for oncology drug treatment decisions.
3. The FDA will request performance information for the tests used to enroll patients into clinical trials
4. Based on an assessment of that information, the FDA will post the minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug.
5. The initial phase of the pilot program is expected to last up to one year.
Why the Program is Important?
The pilot program is developed to check the efficacy of safety tests linked with oncology treatment. There are specific tests that can identify patients who may not respond to developed treatments due to certain genetic mutations, making regulating LDTs for oncology a crucial step. As per the current policy, in certain cases, FDA may approve a life-saving treatment, even if the in vitro diagnostic test has not yet received marketing authorization. Drug development is escalated using LDTs, which are generally not reviewed for safety and effectiveness by the agency. Such LDTs by some laboratories may not be an effective parameter to clinical trials and can negatively impact treatment decisions.
Pilot Program as a Guide to New LDTs
This program entails the FDA’s request to manufacturers for sharing performance information of patients participating in clinical trials. The FDA will utilize the information provided from drug manufacturers to create a guide for other drug manufacturing companies. This guide will outline the minimum performance characteristics necessary for conducting similar tests to identify patients suitable for treatment with the approved drug. Additionally, manufacturers can utilize this information to enhance their own LDTs to identify specific cancer biomarkers
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