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laboratory industry
September 23, 2019 Intelligence: Late Breaking Lab News
Spectra Laboratories, a division of the national dialysis company Fresenius Medical Care, will soon open a new 200,000 square foot laboratory facility in Memphis. The new lab will employ more than 300 people and will be located only 15 minutes from the Memphis Intern…
PGx Testing Labs Concerned by FDA’s Statements, Actions
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…
PGx Labs Concerned by FDA’s Statements, Actions
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…
The Bad News: Disruption. The Good News: Opportunity!
CEO SUMMARY: There was an interesting consensus that emerged from the 80 sessions and 118 speakers at this year’s Executive War College in New Orleans earlier this month. The consensus centered around two themes. One theme is disruption, which is bad news for those labs that hope to mai…
Nine Lab Groups Say New NCCI Policy Is Inconsistent
CEO SUMMARY: By its name alone, the National Correct Coding Initiative (NCCI) Policy Manual implies that it will be accurate and consistent with other coding initiatives. But nine groups representing various clinical laboratories say NCCI guidelines that the federal Centers for Medicare a…
California Lab Company Closes After Negative Medicare Decision
WITH EACH NEW RULING about coverage for a proprietary diagnostic assay, Medicare officials send a message to the entire clinical laboratory industry that any lab company with a proprietary test needs to submit adequate clinical evidence that demonstrates two positive aspects of the test. First, that…
Senator Asks: Are Lab Test Payments Too High?
CEO SUMMARY: It is ironic that, after the federal Centers for Medicare and Medicaid Services (CMS) enacted the deepest price cuts to the Part B Clinical Laboratory Fee Schedule in more than 50 years, a U.S. Senator now asks CMS why it will pay billions more for lab testing. The question f…
Is There a Future for Hospital Lab Outreach Programs?
CEO SUMMARY: This will be one of the most challenging years facing the clinical lab industry since the early 1990s. The CMS scheme to collect private payer lab test prices and use that data to set Medicare clinical laboratory test pric…
Do Community Labs Have a Future in the U.S.?
It may be timely to ask a provocative question that touches everyone in the profession of laboratory medicine. Is there a future for community laboratories and hospital lab outreach programs in the United States, given the different forces acting upon the clinical laboratory industry today? In this …
Expect Significant Disruption during 2019
Each time a new year approaches, it is natural to look ahead and think about what the next 12 months will bring. My bet is that certain sectors of the clinical laboratory industry are soon to experience substantial disruption. This disruption will come in two forms. First, federal regulators will be…
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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