R. Lewis Dark
Articles by R. Lewis Dark
More Labs Recognize Big Changes Are Coming
ONE WAY TO DISCERN THE NEAR FUTURE FOR THE CLINICAL LABO…
Read the Tea Leaves… FDA Will Require LDT Review
PROPOSED FEDERAL REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) IS CURRENTLY THE HOT-BUTT…
FDA Has a Ticking Time Bomb with LDT Rule
PROPOSED REGULATION OF LABORATORY DEVELOPED TESTS (LDTs)…
2024: Year of Decision for FDA Regulation of LDTs
FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION…
Labs: Be Ready for Data to Dominate Diagnostics
By now, it should be clear to clin…
Forensic Pathologist Shortage Gets News Coverage
Pathologists are making headlines in several states, as well as nationally. But this time, the news is not about the shortage of surgical pathologists. Rather, it’s about the acute shortage of forensic pathologists. For example, ABC News reported last month that “Forensic pathologists…
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 use…
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 Administrati…
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 c…
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 pro…
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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