TAG:
genetic test
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…
Health Insurers Want More Data On Clinical Utility of Molecular, Genetic Tests
CEO SUMMARY: Genetic tests that lack two essentials are troublesome for the nation’s health insurers. Those essentials are clinical validity and clinical utility. During a recent webinar, two executives from major health insurers stressed the need for genetic testing labs to provide acc…
Clinical Labs Bidding Up Lab Director Salaries
CEO SUMMARY: There’s great news for pathologists and PhDs with expertise in molecular and genetic testing. Salaries are on the rise as more clinical labs build up their molecular and genetic testing programs and need talent to implement and supervise this activity. One experienced medic…
Pharmacogenomic testing a success at South Dakota health system
This is an excerpt from a 2,700-word article in the January 30 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: One es…
Health System Lab Is Genotyping To Identify Best Drugs for Patients
CEO SUMMARY: One essential element of precision medicine will be the regular use of pharmacogenomic testing to provide additional guidance to physicians when selecting the most appropriate therapeutics and optimal dose for each individual patient. Despite the reluctance of private payers …
PAMA Economics Drives Merger Of Two Seattle-Area Pathology Groups
CEO SUMMARY: Among the three chief reasons for the merger of CellNetix and Puget Sound Institute of Pathology, the most compelling was the need to address the challenges in the current reimbursement environment and to prepare for reductions in payment to pathologists expected in the comin…
Much Disruption for Labs In 2016’s Top 10 Stories
CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab indust…
Why Small Labs and Even Hospitals Are at Risk from PAMA Cuts
CEO SUMMARY: Clinical lab executives and experts who have studied the final rule for PAMA lab test market price reporting are seriously concerned that the design of this rule may put many of the nation’s smallest, but still essential, clinical labs at great risk of financial distress, i…
Should Labs File Court Challenge To PAMA Price Report Rule?
CEO SUMMARY: Just four weeks remain before CMS begins collecting private payer clinical laboratory test price data. Many lab industry executives have charged that Medicare officials are not following the language of the PAMA statute or the intent of Congress. At stake are $5.4 billion in …
Test price data shows major difference between Medicare lab fee schedule and private payers
This is an excerpt from a 1,500-word article in the November 7 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: THE DA…
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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