Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

Commentary and Opinion by R. Lewis Dark

More Labs Recognize Big Changes Are Coming

ONE WAY TO DISCERN THE NEAR FUTURE FOR THE CLINICAL LABORATORY INDUSTRY is to recognize what is different today, compared to the recent past. One source of these insights here at The Dark Report is the many conversations we have as we finalize selecting 140 speakers and panelists to take the podium at 88 sessions …

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Read the Tea Leaves… FDA Will Require LDT Review

PROPOSED FEDERAL REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) IS CURRENTLY THE HOT-BUTTON ISSUE within the clinical laboratory industry. Following the close of public comments on Dec. 4, it is the quiet period while the federal Food and Drug Administration (FDA) reviews the comments and considers changes to the draft rule it issued on Sept. 29, …

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FDA Has a Ticking Time Bomb with LDT Rule

PROPOSED REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) by the federal Food and Drug Administration (FDA) may be the single topic of highest interest within the clinical laboratory and in vitro diagnostics (IVD) industries at this moment. If finalized in its draft form, the new regulation will radically transform a sector of laboratory medicine that uses …

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2024: Year of Decision for FDA Regulation of LDTs

FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION (FDA), it’s been a long road to gain the power to regulate laboratory-developed tests (LDTs). It was in 2014 when the FDA sent a notice to Congress of its intention to begin regulation of LDTs. In the decade since, there has been continuing debate about whether …

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Labs: Be Ready for Data to Dominate Diagnostics

By now, it should be clear to clinical lab managers and pathologists that the game in diagnostics is shifting. Traditionally, lab managers considered a primary goal to be the reporting of accurate test results within the target turnaround times. Going forward, that will no longer be enough. Instead, labs will be rewarded for taking lab …

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Why Many Patients Cannot Pay for Their Lab Tests

IT IS WIDELY RECOGNIZED THAT GOVERNMENT AND PRIVATE PAYERS STEADILY NIBBLE AWAY at what they reimburse clinical laboratories and anatomic pathologists. Lowering the prices paid for tests, excluding labs from networks, and declining to grant coverage for new lab tests are just a few of the tactics used by the health insurance industry to cut …

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Two Forces Push for More FDA Oversight of LDTs

CLINICAL AND GENETIC TESTING LABS MAY SUDDENLY FEEL THEMSELVES STUCK IN THE MIDDLE of a yin-yang situation when it comes to laboratory developed tests (LDTs). One force, the U.S. Food and Drug Administration (FDA), is pulling on laboratories by proposing more stringent requirements for LDTs. Another force, this one by means of Congress, is attempting …

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Is Lab and IVD Consolidation Ready to Hit the Wall?

IN HUMAN HISTORY, ALL ERAS COME TO AN END. The majority of the time, the end of an era is disruptive and a new status quo emerges, with different winners and losers. Today, there is growing evidence that one era in clinical laboratory testing and IVD manufacturing may be close to ending. We present our …

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Provider Price Transparency Trend Has New Twist

IT’S NOT JUST PATIENTS WHO ARE TYPICALLY UNABLE TO SEE PRICES FOR THEIR MEDICAL CARE IN ADVANCE OF SERVICE. Guess who else is unhappy that they cannot access the prices charged by hospitals, physicians, and other providers? It is self-insured companies and unions! Bloomberg recently reported on multiple court cases where a self-insured company or …

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‘Virchow’ Is Your New Source of Managed Care Insights

WE ARE UNVEILING A VALUABLE INTELLIGENCE RESOURCE FOR YOU. It is a new commentary focused exclusively on managed care contracting for diagnostic services provided by clinical laboratories and anatomic pathology groups. We named it “Virchow” in recognition of Rudolf Virchow (1821-1905), the famed German physician who shaped modern pathology and laboratory medicine. Lab leaders need …

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