TAG:
laboratory test
Quest Diagnostics Exits 31-Year-Old CompuNet Lab Venture
This is an excerpt from a 1,362-word article in the June 26, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: For …
Mass Spec Tests Struggle To Gain Insurers’ Attention
CEO SUMMARY: Since 2014, a toxicology lab at the University of Colorado has used mass spectrometry to offer low-cost, accurate multi-analyte test panels that can detect hundreds of therapeutic drugs and drugs of abuse. However, CU Toxicology’s chief medical officer says health insurers …
Quest Diagnostics Exits 31-Year-Old Lab Venture
CEO SUMMARY: News that Quest Diagnostics had exited the long-running CompuNet Clinical Laboratory joint venture in Dayton, Ohio, caught many observers by surprise. The only clues as to possible problems and the motivation of Premier Health, the 51% owner, to buy out Quest’s ownership sh…
31st Physician Pleads Guilty In Federal Lab Fraud Case
AN INTERNAL MEDICINE PHYSICIAN who practiced in Yonkers, N.Y., is the latest physician to admit to taking bribes in connection with a laboratory test referral scheme that Biodiagnostic Laboratory Services LLC (BLS), of Parsippany, N.J., operated for years. The physician, Ricky J. Sayegh, MD, 44, of …
CEO Describes Characteristics Of the Clinical Lab 2.0 Model
CEO SUMMARY: Moving away from volume-based care will not be easy for clinical labs. After all, high volume sustains labs. But labs seeking to transition away from fee-for-service to value-based care must have a seat at the table where decisions are made, said a lab CEO who is part of Proj…
Proposed Bill in Congress Would Regulate LDTs
CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both …
Diagnostic Error Rate Of 21% Revealed By Mayo Clinic Study
CEO SUMMARY: Researchers at the Mayo Clinic showed that only 12% of patients referred to Mayo physicians for a second opinion got a confirmation that their original diagnosis was complete and correct. In 21% of the cases, the diagnosis was completely changed. Among patients who got additi…
Congress Seems Ready to Tackle LDT Regulation
RECENT DEVELOPMENTS SIGNAL THAT THE FIGHT over FDA regulation of laboratory-developed tests (LDTs) is about to intensify. Last month, two Congressional representatives announced a new bill about LDTs that they said was a “discussion draft.” The bill is titled the “Diagnostic Accuracy and Innova…
Texas Lawmakers Asked to Stop UHC and BeaconLBS
CEO SUMMARY: In a letter to the Texas Legislature, 20 Texas medical societies say UnitedHealthcare’s BeaconLBS program would be detrimental to patient care. The Texas Medical Association and the Texas Society of Pathologists said they were concerned that the program increases the admini…
CMS Extends Reporting of Payer Prices by 60 Days
CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number …
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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