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companion diagnostic
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…
What Comes Next for the Pathology Profession?
IT MAY NOT BE A COINCIDENCE THAT MANY RECENT NEWS CYCLES have more negative pathology news than positive pathology news. After all, laboratory medicine is at the core of most clinical care delivered to patients, so it’s no coincidence that pathology—both clinical and anatomic—is a prime target…
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…
Several Big Surprises in 2018’s Top 10 Lab Stories
CEO SUMMARY: This year’s list of the Top 10 Lab Industry Stories for 2018 is dominated by new directives from Medicare and private health insurers, as well as significant decisions by federal courts. Collectively, these developments create new compliance risks for all clinical laborator…
Key Lab Trends Described At Executive War College
CEO SUMMARY: Innovative clinical labs and pathology groups are absorbing this year’s Medicare Part B price cuts while continuing to pursue opportunities to add value. A common theme from many speakers at last week’s Executive War College in New Orleans is that the lab must get mastery…
Powerful Forces Are Reshaping Lab, Pathology
THERE IS NO BETTER WAY TO UNDERSTAND HOW THINGS ARE CHANGING within the house of laboratory medicine than to survey current news. Understanding why and how breaking news stories are indicators of deeply-rooted and forceful trends is essential for lab administrators and pathologists who want to keep t…
Why Pharma, Private Equity Want to Reshape Lab Industry
CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professio…
A coming transformation: Control over important diagnostic technologies is about to change hands
This is an excerpt from a 2,920-word article in the March 26, 2018, 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: He…
Anthem Launches Program to Manage Genetic Tests
CEO SUMMARY: Pre-authorization of genetic tests is coming to physicians serving patients insured by Anthem, Inc. Its specialty benefits management company, AIM Specialty Health, will manage the program. AIM will work with InformedDNA, a company that specializes in genetic testing clinical…
July 25, 2016 Intelligence: Late Breaking Lab News
Throughout the profession of laboratory medicine, concern is surfacing following publication of a proposed rule by the Department of Veterans Affairs (VA) that would expand the authority of Advanced Practice Registered Nurses (APRNs) to supervise and perform laboratory testing. This …
CURRENT ISSUE
Volume XXVII No. 9 – June 22, 2020
THE NEWS ON THE SEROLOGICAL TEST FRONT is discouraging, even bleak, as THE DARK REPORT analyzes the outcome of the FDA’s own review of 11 tests previously listed as marketable. Only three tests passed the review, and yet a quality control expert consulted by THE DARK REPORT has dim views of the FDA’s testing operation, leading to even more doubts. Also, health insurers are scraping away at mandated COVID-19 test reimbursements, leaving lab revenues once again at their mercy.
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