Top Articles
With LDT Rule Vacated, Labs Await FDA Retort
Judge decries idea of LDTs as medical devices, but FDA could step in elsewhere, experts say
CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form...
In the Past, Labs Used Courts to Thwart Feds
Back in 2008, clinical labs squared off with CMS and the agency eventually backed off
CEO SUMMARY: A federal judge’s recent decision to vacate the FDA’s final rule on laboratory developed tests harkens back to a 2008 case where clinical labs stopped a CMS competitive bidding project. In the earlier case, legal risks led the government to back down. The ...
Testing at Pharmacies Enters a Murky Future
Did predictions for pharmacies to become more prominent in diagnostic testing go bust?
CEO SUMMARY: Five years ago, it seemed a solid prediction that retail pharmacies would establish a stronghold in primary care and offer wider access to common diagnostic testing services that clinical laboratories provide. Fast forward to 2025, and the market does not look...
BD Will Sell Diagnostics Arm but Retain Vacutainer Brand
Published report indicates BD is already courting other companies about the spinoff plans
LESS THAN TWO MONTHS AFTER ANNOUNCI...
OPKO Settles Allegations of Fraudulent Billing
Whistleblower questions on routine CBC test billing lead to a $700k settlement with the government
DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S....
Clinical Lab Test Jargon Could Spur Mistrust among Patients
Octavia Peck Palmer encourages laboratories to be clear about diagnostic test names and purposes
LITTLE DETAILS CAN MAKE A BIG DIFFERENCE in not only how customers view a clinical laboratory, but also in ensur...
Enjoy the LDT Court Victory, Yet Remain Vigilant
VICTORY IN COURT! FOR AN INDUSTRY THAT OFTEN FINDS ITSELF on the wrong end of legal deliberations (see ...
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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