TDR Insider Archives

Lab Innovators in Europe Have Solutions for the USA

Rapid advances in a wide range of technologies over the past 15 years are enabling entrepreneurs to create transformative products for use by clinical laboratories and anatomic pathology groups. The Dark Report recently toured Europe to visit several such innovative companies. One clever invention is an “autonomous blood drawing system” that automatically performs venipunctures and […]

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Uncertainty in the Market for Digital Path Products

TDR Insider / Robert Michel

These are uncertain times for many companies offering a range of digital pathology (DP) products to the nation’s pathologists. Sales lag behind projections that caused investors to pour money into numerous DP start-ups. One reason DP companies are not meeting sales goals is the inherent caution common with pathologists when it is time to make

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Identifying Current Lab Trends from Labcorp and Quest Experience

TDR Insider / Robert Michel

Many different factors influence the operations of clinical laboratories in the United States today. One good source of competitive business intelligence is for lab administrators to follow the quarterly earnings calls of the nation’s two biggest public lab corporations. With coast-to-coast operations, they are often first to experience and respond to new trends—whether its more

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What Labs with LDTs Must Do to Comply with the FDA’s LDT Rule

TDR Insider / Robert Michel

Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This compliance will require substantial staff time and costs that may outweigh the benefit to the lab

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Clinical Labs Face New Consumer-Driven Trend

TDR Insider / Robert Michel

THERE IS A NEW CLASS OF CLINICAL LABORATORIES THAT ARE BUILDING MOMENTUM in the United States today. These are labs serving what The Washington Post described as a “new world of DIY [do-it-yourself] testing.” The Dark Report relates an investigative report by The Post, which states, “A new world of DIY testing is changing the

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ACLA Files Federal Court Challenge to FDA’s Final LDT Rule

TDR Insider / Robert Michel

BATTLE LINES ARE NOW DRAWN ON WHAT IS PROBABLY THE BIGGEST CONFRONTATION between the clinical laboratory industry and federal regulators in the past 50 years. On May 29, the American Clinical Laboratory Association (ACLA) with co-plaintiff HealthTrackRx filed a major lawsuit against the federal Department of Health and Human Services (HHS) and Food and Drug

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New CISA Proposed Rule Mandates Rapid Reporting of Cyberattacks

TDR Insider / Robert Michel

There is another federal rule that will require compliance by clinical labs. An agency of U.S. Dept. of Homeland Security published a draft rule on April 4 that requires certain organizations—including hospitals, clinical labs, and pathology groups—to report, within 72 hours, any cyberattack and the payment of any ransom payments associated with a cyberattack. The

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Wisconsin Diagnostic Lab’s Alternative Staff Solutions

TDR Insider / Robert Michel

Even as clinical laboratories and pathology groups around the nation cope with a sustained shortage of qualified staff, the team at Wisconsin Medical Laboratories has successfully kept staffing at 96% of authorized levels. One effective strategy they use is to go into the community to educate recent college graduates and high school students about the

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Lab Market Is Fragmenting, Creating New Opportunities

TDR Insider / Robert Michel

Even as consolidation continues in the ownership of hospitals, health systems, office-based physicians, and clinical laboratories, there is a powerful trend of fragmentation quietly transforming the way providers—including clinical labs and pathology groups—serve patients and consumers who want specialized expertise and choice. Today’s market for clinical laboratory testing services is fragmenting at a pace that

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Labs and Path Groups Should Prepare for Arrival of ‘Perfect Storm’

TDR Insider / Robert Michel

In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming reforms and updates to the 1992 CLIA rules. This is

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