Top Articles

Federal Judge Rules Against ACLA in Its PAMA Lawsuit

Dismissal of PAMA lawsuit raises questions about next steps for clinical laboratory industry

CEO SUMMARY: Now that a federal judge has ruled that the American Clinical Laboratory Association’s lawsuit is moot and dismissed the case, it is unclear what next steps are open to ACLA and the clinical laboratory industry in their challenge to how the federal Centers for Medicar...

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Lab Market Update Amazon Sells COVID-19 Test Kit for At-Home Use by Consumers

Experience at selling a COVID-19 saliva test could encourage the company to offer other lab tests

QUIETLY AND WITHOUT MUCH ATTENTION, online retailing giant Amazon began to sell a COVID-19 molecular test to consumers for at-home testing. This is consistent with other actions Amazon has taken to generate revenue during the SARS-CoV-2 pandemic.  ...

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IVD Update IVD Firms Report Strong Growth Because of COVID-19 Testing

For most of the world’s in vitro diagnostics (IVD) companies, 2020 shaped up to be a stellar year

TO NO ONE'S SURPRISE, THOSE IN VITRO DIAGNOSTICS (IVD) MANUFACTURERS that produce molecular tests, instruments, and automation used for COVID-19 testing reported strong growth in revenue and profits during 2020.  In recent weeks, these companies issued t...

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Is Artificial Intelligence Ready for First Use in Anatomic Pathology?

Expert in digital imaging anticipates wider use of AI in image analysis

CEO SUMMARY: Use of artifical intelligence (AI) to analyze digital pathology images and aid in diagnosis—or even in making the primary diagnosis—is much discussed. Experts in pathology regularly predict that use of AI in image analysis will transform the pathology profession. Bu...

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Lab Briefs: Roche, GenMark Diagnostics, Thermo Fisher, Mesa Biotech, ProPath

Roche to Acquire GenMark Diagnostics LAST MONTH, Roche and GenMark Diagnostics announced a definitive merger agreement for Roche to acquire GenMark in a transaction valued at $1.8 billion. ...

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Restitution and Guilty Plea in Two Lab Fraud Cases

Outcomes in separate cases alleging fraud involving lab tests were announced last month

CEO SUMMARY: In one case, owners and a sales rep agreed to pay restitution totaling almost $10 million. In the second case, three defendants pled guilty to federal charges involving payment or receipt of kickbacks and illegal inducements. A fourth defendent in this second case, a ph...

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Lab Profession’s ‘Haves,’ ‘Have Nots,’ and Thieves

ONCE AGAIN, THE LATEST NEWS OF IMPORTANCE in the clinical laboratory industry includes disparate topics that include legal/regulatory, new technology in anatomic pathology, fraud involving lab testing, and more consolidation in the in vitro diagnostics (IVD) industry.  You will find coverage on all of these topics and mo...

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