New rule aims to improve accuracy and safety of medical tests
- FDA brings lab tests under federal oversight
- Regulation aims to ensure accuracy and safety of medical tests
- New tests will need FDA approval within 3.5 to 4 years
- Existing tests will be grandfathered in without federal review
- All lab tests required to register with the FDA and report problems
- FDA won’t require approval for tests with no alternatives
- Industry opposes regulation, citing concerns about access and innovation
The U.S. Food and Drug Administration (FDA) has finalized a regulation that will bring lab tests under federal oversight. The goal of the regulation is to ensure that new tests for various illnesses, including cancer, heart disease, and COVID-19, are safe, accurate, and reliable. Under the new rule, newly developed tests that pose a high risk will need FDA approval within 3.5 years, while lower-risk tests will have four years to obtain approval. Existing tests currently on the market will not have to undergo federal review. However, all lab tests, both old and new, will be required to register with the FDA and report problems or errors. The FDA will use this information to target problematic tests. The agency also won’t require approval for tests with no alternatives, such as those for certain rare diseases. The regulation has faced opposition from the testing industry, which argues that it will stifle innovation and increase costs.
Factuality Level: 8
Factuality Justification: The article provides a detailed and factual overview of the new FDA regulation on medical tests, including the timeline for compliance, the goal of ensuring accuracy and reliability, and the potential impact on the industry. It includes quotes from FDA officials and industry representatives to present different perspectives on the issue. The article also mentions historical context and concerns about inaccurate tests, giving a comprehensive view of the topic.
Noise Level: 3
Noise Justification: The article provides relevant information about a new government rule on oversight of medical tests. It discusses the potential impact on the testing industry, the reasons behind the regulation, and the timeline for compliance. The article includes quotes from FDA officials and industry representatives, giving a balanced view of the situation. However, the article contains some repetitive information and could be more concise in its reporting.
Financial Relevance: Yes
Financial Markets Impacted: The regulation may impact the testing industry, including medical-device manufacturers, labs, hospitals, and universities that develop their own in-house tests. Companies such as Quest Diagnostics and LabCorp may also be affected.
Presence Of Extreme Event: No
Nature Of Extreme Event: No
Impact Rating Of The Extreme Event: No
Rating Justification: The article discusses a new government regulation that will require makers of medical tests to show that their new offerings deliver accurate results. While this may impact the testing industry, there is no mention of an extreme event or its impact.
Public Companies: Quest Diagnostics (DGX), LabCorp (LH)
Key People: Robert Califf (FDA Commissioner), Jeff Shuren (Director of the FDA’s device center)
Reported publicly:
www.marketwatch.com 
