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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 companie...
Uncertainty in the Market for Digital Path Products
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 ...
Identifying Current Lab Trends from Labcorp and Quest Experience
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 oper...
What Labs with LDTs Must Do to Comply with the FDA’s LDT Rule
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 subs...
Clinical Labs Face New Consumer-Driven Trend
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."...
ACLA Files Federal Court Challenge to FDA’s Final LDT Rule
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 ma...
New CISA Proposed Rule Mandates Rapid Reporting of Cyberattacks
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 ...
Wisconsin Diagnostic Lab’s Alternative Staff Solutions
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 ...
Lab Market Is Fragmenting, Creating New Opportunities
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 s...
Labs and Path Groups Should Prepare for Arrival of ‘Perfect Storm’
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 1...
Don’t Be at the Mercy of the Tumultuous Healthcare Revolution
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CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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