TAG:
genetic test
Medicare Contractor’s Ruling on MolDx Test Causes Lab to Close
CEO SUMMARY: On May 14, Predictive Biosciences learned that its Medicare contractor had determined that one of its three molecular tests for bladder cancer was a screening test. It also never got a determination on its other two molecular tests. Because Medicare is half of the lab’s pay…
Why a Divided Lab Industry May Soon Fall
OVER THE PAST TWO DECADES, it has often been remarked on these pages and by many others that the divided nature of the laboratory medicine profession will prove to be its ultimate Achilles heel. These divisions center around different scientific disciplines within pathology and lab medicine as well a…
Big Lab Industry Stories Reveal Trouble Ahead
CEO SUMMARY: One after another, a series of breaking news stories points to more rough waters ahead for the entire clinical lab industry. Of greatest interest is the ongoing questions about when clinical labs and pathology groups will get paid for the molecular test claims they have submi…
Health Insurers See Big Increase in Lab Utilization
CEO SUMMARY: In a recent public workshop, managed care executives revealed that the annual cost of outpatient laboratory testing is increasing at twice the rate of all other medical services. One big driver in the increased spending on lab testing is increased utilization…
Why One Molecular Diagnostics Company Closed Its Doors
CEO SUMMARY: When executives closed the doors of Pathwork Diagnostics last month, the simple explanation was that reimbursement for its proprietary molecular diagnostic test was inadequate. Indeed, that was part of the story. But other factors played significant roles in impeding…
May 28, 2013 “Intelligence: Late Breaking Lab News””
Globalization of laboratory medicine continues to move forward. Two recent examples illustrate this trend. Earlier this month, the University of Pittsburgh Medical Center (UPMC) announced that it had entered into an agreement with the Citizens Hospital of Hyderabad, …
Dartmouth Builds New Lab to Serve Growth in Testing
CEO SUMMARY: Demand for specialized reference and esoteric testing is so robust at Dartmouth Hitchcock Medical Center in New Hampshire that the academic center is building an expanded laboratory facility to accommodate the increased volume of tests it handles each year. A favorable trend …
May 06, 2013 “Intelligence: Late Breaking Lab News”
Much is happening in the anatomic pathology market in the Pacific Northwest. PAML, LLC (Spokane, Washington), and CellNetix (Seattle, Washington) finally executed the agreement whereby PAML made an equity investment in CellNetix. Now, the two lab companies will collaborate on developing…
Medicare Taken to Task about Molecular Test Pricing Method
EDITOR’S NOTE: Submitted by Lâle White, CEO of XIFIN, Inc., of Carlsbad, California, this letter describes the problems caused by the Medicare program’s failure, as of January 1, 2013, to be ready to process and reimburse lab test claims for more than 100 new mo…
Mass Spectrometry Is Finding Larger Role in Clinical Labs
CEO SUMMARY: Mass spectrometry is a diagnostic technology that is transforming clinical labs and improving care at a rapid pace. The current generation of instruments is capable of supporting a faster time-to-answer and provides improved accuracy and specificity over many existing methods…
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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