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FDA Clearance
Market Hesitates to Embrace Automated Screening Products
CEO SUMMARY: Technology to enhance and improve conventional Pap smear screening was introduced into the clinical marketplace almost five years ago. But the clinical laboratory industry has yet to embrace these various technologies in any meaningful way. Like the introduction of liquid pre…
“July 31, 2000 Intelligence: Late Breaking Lab News”
Medical Management Programs, Inc. (MMP) of Southfield, Michigan is the new owner of the TPA (third party administrator) business formerly held by Universal Standard Medical Laboratories. MMP purchased the TPA business involving lab testing and home health services from USML’s Chapt…
Neurology is Test Focus For Athena Diagnostics
CEO SUMMARY: There are few examples of laboratory companies focused on a single medical specialty,a business model that is expected to become more common in coming years. One such company is Athena Diagnostics. For 12 years, this company has concentrated on providing diagnostic testing fo…
Questions Remain About Performance Of Liquid-Prep Paps
CEO SUMMARY: During the past five years, several companies entered the lab marketplace with claims that their new Pap test technologies are improvements over conventional Pap smear methods. Armed with investment capital from Wall Street, these companies launched aggressive sales and marke…
Bio-Reference Labs, CARESIDE, United Healthcare, MetLife, Foundation Health
BIO-REFERENCE LABS MOVES TO START PATIENT-DOCTOR MESSAGING ONE OF THE NATION’S MORE AGGRESSIVE efforts to refocus the clinical laboratory organization can be found at Bio-Reference Laboratories, Inc., located in Elmwood Park, New Jersey. Bio-Reference wants to use its bas…
Epitope, LabOne, CARESIDE, Quest, Structural Bioinformatics, UroCor
EPITOPE RAIDS LABONE FOR NEW PRESIDENT/CEO; READIES DRUGS OF ABUSE MARKET LAUNCH DURING THE YEAR 2000, Epitope, Inc., based in Portland, Oregon, plans to introduce a drugs of abuse test based on its patented OraSure® oral collection technology. To aid in this new product l…
Abbott, CARESIDE, Bio-Reference Labs, DIANON Systems
SWARM OF LAWSUITS NOW PLAGUES ABBOTT LABS PAYING A $100 MILLION FINE TO THE Food and Drug Administration (FDA) did not end Abbott Laboratories, Inc.’s problems related to its diagnostic test kits and reagents. Since payment of the FDA fine last month, Abbott has been serv…
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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