FDA Readies Proposal for Increased Oversight on Lab-developed Tests
Portfolio Pulse from Vandana Singh
The FDA is preparing to increase regulation on lab-developed tests used to detect cancer, measure cholesterol, and identify other health issues. This move may face opposition from the $10 billion industry, including companies like Laboratory Corporation Of America Holdings (LH) and Quest Diagnostics Inc (DGX).

June 08, 2023 | 6:00 pm
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NEGATIVE IMPACT
Quest Diagnostics Inc (DGX) may be affected by the FDA's plan to increase regulation on lab-developed tests, as it is a significant player in the industry.
The FDA's increased regulation on lab-developed tests may lead to additional compliance costs and potential changes in business practices for Quest Diagnostics Inc (DGX). As a significant player in the industry, DGX may face challenges adapting to the new regulations, which could negatively impact its stock price in the short term.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 80
NEGATIVE IMPACT
Increased FDA regulation on lab-developed tests may impact Laboratory Corporation Of America Holdings (LH), as it is a prominent player in the industry.
The FDA's increased regulation on lab-developed tests may lead to additional compliance costs and potential changes in business practices for Laboratory Corporation Of America Holdings (LH). As a prominent player in the industry, LH may face challenges adapting to the new regulations, which could negatively impact its stock price in the short term.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 80