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lab test

Predicting Future Demand for COVID-19 Testing

CEO SUMMARY: After 15 months of the pandemic, the nation’s clinical laboratories are at an interesting crossroads. Is the COVID-19 outbreak diminishing and close to disappearing? Or might it intensify again, particularly when the traditional influenza season arrives next fall? The…

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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 ph…

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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…

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What Comes Next? Predictions on COVID-19 Test Volumes in 2021-22

CEO SUMMARY: Incoming data show that the number of referrals for both COVID-19 tests and routine tests is in a decline that started in October and is continuing. This complicates the strategic planning for hospital/health system labs, independent labs, and pathology groups. They nee…

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New Year Brings Three New Clinical Lab Trends

CEO SUMMARY: Since the year began, three trends have affected clinical laboratories and anatomic pathology groups. First is a continuing surge in COVID-19 test volume. Second is inconsistent payment from government and commercial insurers for SARS-CoV-2 test claims. Third is growing…

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Pathology Lab Transforms, Runs 1M COVID-19 Tests

CEO SUMMARY: Last spring, a histopathology lab in Illinois began running molecular COVID-19 tests and decided the clinical side of the lab would focus exclusively on PCR testing for COVID-19. The challenge was how to access a reliable source of test kits, reagents, and supplies to o…

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Academic, Commercial Collaboration for Testing

CEO SUMMARY: In several important ways, this collaboration involving an academic clinical laboratory and a commercial company has paid big dividends, not just for the two partners, but also the parent university that oversaw the project. The two partners developed a SARS-CoV-2 test, t…

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Two-Drop ‘Digital CBC’ Enters U.S. Market with FDA Clearance

“We believe the ability to work with just two drops of blood, plus the…

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January 19, 2021 Intelligence: Late-Breaking Lab News

Just days ago, the federal Food and Drug Administration (FDA) issued updated information about the COVID-19 tests it has authorized since early in the pandemic. As of Jan. 15, 2021, the agency had authorized a total of 317 tests for the SARS-CoV-2 coronavirus. Included in this total are 236 mo…

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UK Postpones Mass COVID Testing Plan Due to Questions of Accuracy

IN THE UNITED KINGDOM, A MASS COVID-19 TESTING PLAN called “Operation Moonshot” is on hold until at least the end of January. Under the plan, health ministers sought to increase daily SARS-CoV-2 testing from 430,000 to 10 million Englanders per day.  …

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