TAG:
laboratory industry
50,000 Patients to Retest After Invitae Finds Errors
CEO SUMMARY: In recent weeks, a client notified Invitae of discordant results on a patient. The notification caused the genetic testing company to discover it had a systemic error that failed to test for a specific rare mutation associated with inherited cancer. Company officials believe …
Invitae genetics lab to retest 50,000 patients after finding errors
This is an excerpt from a 1,400-word article in the August 28, 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: In…
NILA Asks Labs to Speak about PAMA Rule’s Flaws
CEO SUMMARY: In a call to action, the National Independent Laboratory Association is urging lab owners, lab managers, and pathologists to educate their members of Congress about the biases and deep flaws built into the final rule for PAMA market price reporting and how the rule will resul…
LabCorp, Quest Talk about Medicare Lab Price Cuts
CEO SUMMARY: In an effort to forestall CMS’ efforts to implement the PAMA final rule on market price reporting, Laboratory Corporation of America and Quest Diagnostics are meeting with members of Congress, officials in the administration, and the new leadership of CMS. During recent con…
Time’s running out to stop Medicare lab fee schedule cuts
This is an excerpt from an article in the August 7, 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: Only a few mo…
Hospital Lab Data Essential For CMS Market Price Study
CEO SUMMARY: In five months, Medicare officials will implement a new Part B clinical laboratory fee schedule based on private payer lab price data submitted by certain medical laboratories required to report that data. At this year’s Executive War College, the CEO of XIFIN, Inc., reported o…
Genetic Test Pre-Authorization Goes Mainstream
IT IS ALWAYS A BIG DEAL WHEN ONE OF THE NATION’S LARGEST HEALTH INSURERS TAKES A MAJOR STEP. That is certainly true of Anthem’s decision to launch a new program that requires physicians to obtain pre-authorization when ordering genetic tests for its members. THE DARK REPORT is f…
Why It Matters That Your Lab Has Low Test Prices
TODAY, THE LAB INDUSTRY FACES A CONTRADICTION when setting prices for individual lab tests. At one extreme, a certain sector of labs seeking to win exclusive managed care contracts sets high-volume routine test prices at or below the fully-loaded cost to perform those tests. At another extreme, labor…
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…
Federal Regulation of LDTs Subject of Proposed Bill
THERE’S A NEW BATTLE over laboratory-developed tests (LDTs) looming on Capitol Hill. In response to the FDA’s draft guidance to regulate LDTs, a bill has been proposed by two members of the house that would shape LDT regulations in different ways than proposed by the FDA. The Diagnostic Accuracy…
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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