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The Washington Post
Regeneron Loses 23andMe Bid to TTAM Research Institute
23andMe FOUNDER AND FORMER CEO ANNE WOJCICKI has successfully retained control over her company by selling it to her nonprofit medical research firm TTAM Research Institute for $305 million. This followed bidding between TTAM Research Institute and Regeneron Pharmac…
LDT Oversight May Fall to Congress, CLIA
CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
April 21, 2025, Intelligence: Late-Breaking Lab News
The administration of President Donald Trump is calling for a $40 billion cut in funding to the U.S. Department of Health and Human Services (HHS), according to a report in The Washington Post on April 16. This amount would come from HHS discretionary spending,…
State of Whole Genome Sequencing of Newborns
CEO SUMMARY: Genetic medicine continues to support advances in precision medicine (or personalized medicine, if you prefer). This is true in pediatrics, where several statewide pilot programs—each involving tens of thousands of newborns—are publishing studies that demonstrate how exom…
September 23, 2024, Intelligence: Late-Breaking Lab News
One sign of the financial turmoil associated with the market for genetic tests is the news that all seven independent directors of 23andMe’s board resigned at the same time on Sept. 18. The reason given was that these directors opposed the plan of CEO and co-founder Anne Wojcicki t…
CURRENT ISSUE
Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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