TAG:

IVD

2021 Rankings of the World’s Top 12 IVD Companies

WHILE THERE WAS SOME JOCKEYING FOR NEW positions, in vitro diagnostics (IVD) manufacturers remain entrenched in their market based on The Dark Report’s 2021 ranking of the Top 12 IVD Companies.  COVID-1…

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Public Laboratory Companies Eye More Lab Outreach Acquisitions

PUBLICLY-TRADED CLINICAL LABORATORY COMPANIES released second quarter 2022 financial reports that confirmed a softening demand for COVID-19 tests, even as their base business revenues grew compared to last year.  While continuing to address ongoing needs…

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News and Insights from AACC Meeting in Chicago

CEO SUMMARY: There was plenty of positive energy last month when the 72nd Annual Scientific Meeting and Exhibition of the American Association of Clinical Chemistry (AACC) took place in Chicago. Attendees seemed pleased to be gathering and networking in person. However, there was re…

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Coverage, Reimbursement Still Difficult for New Lab Tests

CEO SUMMARY: Bringing a new proprietary diagnostic test to market is an arduous process. It takes patience and planning to complete the journey from test development to payer reimbursement. This slow process stems from the fact that the healthcare reimbursement system is fragmented,…

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Might LDT Regulation Bill Support Be Waning in Congress?

This is an excerpt of an 833-word article in the July 18, 2022 issue of  THE DARK REPORT. The full article is available to members of The Dark Intelligence Group.   …

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Important Court Rulings & Pending New Federal Law 

IMPORTANT THINGS ARE HAPPENING WITH COURT DECISIONS AND PROPOSED FEDERAL LEGISLATION that will affect a substantial number of the nation’s clinical laboratories and anatomic pathology groups. In this issue of The Dark Report, you’ll be alerted to those developments we th…

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Might VALID Act Support Be Waning in Congress?

CEO SUMMARY: Just weeks ago, events seemed to indicate that the Verifying Accurate Lea…

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Passage of FDA Regulation of LDTs Inches Closer in the Senate

CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. …

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Lab Vendors Adjusting to Changing Sales Practices

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June 6, 2022 Intelligence: Late-Breaking Lab News

Monkeypox is the latest disease showing up in the United States. That means hospital laboratories will want to be ready to diagnose monkeypox cases that show up in their emergency departments. An official from the Centers for Disease Control and Prevention (CDC) says it is exploring the possib…

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