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COVID-19 test

QuidelOrtho Earns $3.3 Billion in First Year as Combined Firm

IN OUR FEBRUARY 13, 2023, ISSUE OF THE DARK REPORT, we analyzed the 2022 full-year and Q4 earnings of major IVD companies. At the time our prior issue went to press, QuidelOrtho had not yet reported its year-end results.  …

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Whistleblower Lab Manager Files Response to PerkinElmer Lawsuit

IN A DAVID-VERSUS-GOLIATH-LIKE BATTLE, perhaps the most unusual lawsuit in decades involving clinical laboratory operations and compliance is unfolding in a federal courthouse in California. In this case, a multi-billion-dollar in vitro diagnostics (IVD) company is suing a laboratory manager w…

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June 14, 2021 Intelligence: Late-Breaking Lab News

Is it possible to use a genetic test to predict an individual’s risk of severe infection requiring hospitalization or death from SARS-CoV-2? That is the claim of Australian-based molecular diagnostics company Genetic Technologies Limited. It recently announced an agreement with U.S.-based …

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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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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.  …

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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 t…

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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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Might Politics Sway California Lab’s CLIA Compliance?

IS IT A CONFLICT FOR A STATE GOVERNMENT TO BUILD AND OPERATE A CLIA high-complexity clinical laboratory and have the same department that manages this lab facility also conduct the CLIA-mandated inspections and oversight of the lab’s compliance, as required by the federal Clinical Laboratory Improv…

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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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