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November 2022

Ravgen Gets $272.5 Million Verdict against Labcorp

Genetic Testing, Lab Risk & Compliance, The Dark Report / By

CEO SUMMARY: In September, a jury returned a $272.5 million verdict against Labcorp, representing royalties owed to biotech company Ravgen for infringement of its diagnostic genetic test patent. Soon after, Quest Diagnostics settled a similar lawsuit with Ravgen before its trial began. The victories against the two largest commercial labs illustrate the risks of navigating …

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Newsmaker Interview: Director of CDC’s Division of Laboratory Systems Talks COVID-19, CLIA, and More

Clinical Laboratory Trends, People, The Dark Report / By

CEO SUMMARY: In this exclusive interview, Reynolds Salerno, PhD, the Director of the Division of Laboratory Systems at the CDC, offers insightful comments about the federal agency’s response to the SARS-CoV-2 pandemic, what went right during public health efforts, and lessons that were learned. He also discusses how labs have dealt with the recent monkeypox …

Newsmaker Interview: Director of CDC’s Division of Laboratory Systems Talks COVID-19, CLIA, and More Read More »

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Reports Say Qiagen and Bio-Rad Discussing Potential IVD Merger

Clinical Laboratory Trends, In Vitro Diagnostics, IVD/Lab Informatics, The Dark Report / By

More consolidation in the in vitro diagnostics (IVD) mar­ket may soon happen. Bio-Rad Laboratories and Qiagen are reportedly in merger discussions. The Wall Street Journal, which broke the story on Oct. 10, tabbed the potential deal as being worth $10 billion should it go through. Both companies have a global pres­ence and make most of …

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Ex-Theranos CEO Elizabeth Holmes Awaits Ruling on New Trial Request

Lab Risk & Compliance, The Dark Report / By

Keeping with the unexpected and odd circumstances sur­rounding Theranos, a federal judge heard arguments on Oct. 17 about whether convicted company founder Elizabeth Holmes’ should get a new trial. That hearing stemmed from the gov­ernment’s star witness in Holmes’ 2021 trial—a pathologist—visiting her home in August to speak with the disgraced former Theranos CEO. As …

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U.S. Hospitals Will Lose Billions of Dollars in 2022

Clinical Laboratory Trends, Lab Intelligence, Laboratory Management, The Dark Report / By

CEO SUMMARY: Hospitals and health systems in most regions of the United States are reporting substantial losses, both in patient care and in the value of their investment portfo­lios. This is inauspicious for the clinical laboratories operated by these hospitals. Hospital-based managers can expect more pressure to cut lab costs continually, even as they must …

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Clinical Laboratory News from North of the Border

Commentary and Opinion by R. Lewis Dark / By

In mid-October, Canada’s largest national conference for diag­nostics leaders took place in Toronto. It was their first gathering since the onset of the pandemic and much is happening with healthcare and medical laboratories in our northern neighbor. The Dark Report was there to identify innovative developments that might be useful to our clients and regular …

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