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Q2 2024 Lab & Diagnostics Update

Provident Healthcare Partners
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Q2 2024 Lab & Diagnostics Update

The most notable development in the lab and diagnostics space coming out of Q2-24 is the FDA’s final ruling on oversight of Laboratory Developed Tests (“LDTs”). In late May, the American Clinical laboratory Association (ACLA) filed a lawsuit against the FDA, claiming that the FDA never received permission to regulate LDTs as medical devices, as opposed to medical services. With the additional overturning of the Chevron deference, limiting the power of federal agencies to interpret vague descriptions of law, companies await the outcome of the lawsuit as it is expected to have serious implications on how lab business is conducted moving forward.

Previous enthusiasm for technological advancements continued into second quarter activity, with notable activity in digital pathology and lab devices fueled by favorable regulatory conditions. Labcorp, global leader of advanced laboratory services, had the most activity by purchasing substantial assets of bankrupt medical genetics company Invitae and BioReference Health.

To print and download the full Lab & Diagnostics Update report, please click below…

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