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Multi-Modality Diagnosis Heading for Lab Medicine
CEO Summary: At the upcoming Molecular Summit in Philadelphia on February 10-11, 2009, pathologists, molecular imaging experts, and informaticians will share the latest developments on the integration of in vivo (imaging) and in vitro (pathology) diagnost…
Hospital Lab Takes CMS To Court in CLIA Case
CEO SUMMARY: A California hospital challenged CMS in federal court over the threatened loss of its lab’s CLIA certificate. CMS threatened to revoke the certificate in 2007 and stop paying the hospital’s Medicare and Medi-Cal lab bills. In January, Victor Valley Community Hospital won …
Powerful Trends Reshaping Anatomic Path Profession
CEO SUMMARY: THE DARK REPORT presents its newest biannual review of macro trends reshaping the anatomic pathology profession. These macro trends reveal a profession undergoing change and transformation on multiple fronts. New competitors are crowding into the market, payers and accreditin…
How PAML Built a Major Business In Lab Joint Ventures with Hospitals
“A well-structured laboratory joint venture helps the hospital partner tap the unrealized value of its laboratory, because the independent lab partner provides capital, along with experience, and expertise to s…
Beckman Coulter, Biosite, Inverness, MedTox, Group Health, Henry Ford, Johns Hopkins
BECKMAN COULTER HOPES TO COMPLETE ACQUISITION OF BIOSITE FINGERS ARE CROSSED at Beckman Coulter, Inc., as the company hopes to complete its acquisition of Biosite, Inc., by tomorrow night (May 15 at midnight). Its original offer to …
Lots of IVD Acquisitions as Buyers Spend Money
CEO SUMMARY: Biggest deal in recent weeks was the $1.55 billion Beckman Coulter paid to acquire BioSite and its Triage BNP test. But the most interesting news may be the entry of 3M Corporation into clinical diagnostics, based on its acquisition of Acolyte Biomedica Ltd.,…
Payer Sues Pathologists For Clin Path Fee Refund
CEO SUMMARY: In September, Anthem filed three lawsuits against pathology groups in Virginia, seeking refunds and punitive damages of up to $1million from each pathology group for pathology professional services provided in hospital labs by these pathology groups during the period 2001 thr…
Bio-Reference Enters DNA Sequencing Market
CEOSUMMARY: Bio-Reference Laboratories has just placed an unexpected bet on the wide-open opportunities in genetic testing. The acquisition of GeneDX brings it a respected team of geneticists, capabilities in full DNA sequencing, and a proven track record in testing for rare and complex h…
Merck’s HPV Vaccine Cleared For Use by FDA Last Week
IT’S BEEN A RACE between two pharma giants to get an HPV (Human papillomavirus) vaccine into the market. Last Thursday, Merck & Co., Inc. jumped ahead of GlaxoSmithKline. That was the day that the Food and Drug Administration (FDA) cleared Mer…
CYP450 Testing To Have Major Clinical Impact
CEO SUMMARY: Pharmacogenomics, companion diagnostics, “personalized prescription drug therapy”—by any name, use of molecular diagnostics to guide clinicians in the prescribing and dosing of drugs is about to expand exponentially. Some experts predict that CYP450 testing alone will …
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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