Month: April 2021

Lab Professions ‘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 more in this issue of The Dark Report. …

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Federal Judge Rules Against ACLA in Its PAMA Lawsuit

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 Medicare and Medicaid Services is implementing the Protecting Access …

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

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.  The test Amazon sells is the DxTerity COVID-19 Saliva at-Home Collection Kit. The test was developed by DxTerity, …

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IVD Firms Report Strong Growth Because of COVID-19 Testing

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 their earnings reports for the fourth quarter 2020 and full year 2020. As expected, most companies announced substantial increases …

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Is Artificial Intelligence Ready for First Use in Anatomic Pathology?

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. But that leaves one important question unanswered: When will AI be ready for prime …

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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.  Roche called attention to GenMark’s syndromic panel testing portfolio and said this line of molecular tests would strengthen its products for infectious disease testing in hospitals, particularly …

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Restitution and Guilty Plea in Two Lab Fraud Cases

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 physician, awaits trial. These smaller cases come just months …

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April 12, 2021 Intelligence: Late-Breaking Lab News

One clinical laboratory company now says it provides COVID-19 testing services to all five of the major men’s professional sports leagues in the United States. On April 1, BioReference Laboratories, Inc. (BRLI), a division of Opko Health, announced a new agreement with Major League Baseball. In its press release, BRLI said it will provide COVID-19 …

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