TAG:
ldt
Six Important Themes to Help Labs Succeed
CEO SUMMARY: Clinical laboratories face business challenges with day-to-day operations, genetic testing, and evolving care delivery models. The 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management returns on April 25-26 in New Orleans. Participant…
March 6, 2023, Intelligence: Late-Breaking Lab News
Since Congress did not include new regulations for laboratory-developed tests (LDTs) in a year-end spending budget, it appears the Food and Drug Administration (FDA) will take steps of its own to increase the agency’s oversight of LDTs. “We are moving forward with rulemaking,” said Eliza…
January 3, 2023, Intelligence: Late-Breaking Lab News
At the moment, it appears that the controversial Verifying Accurate Leading-edge IVCT Development (VALID) Act will have a hard time passing in Congress. The bill, which is intended to shift regulation of laboratory-developed tests (LDTs) to the federal Food and Drug Administration…
2022’s Top 10 Lab Stories Confirm Challenging Times
CEO SUMMARY: There are valuable insights to be gleaned from The Dark Report’s “Top 10 Lab Industry Stories for 2022.” Several of this year’s story picks involve external forces reshaping healthcare in the United States in profound ways. Other story picks for 2022 illustrate …
VALID and SALSA Acts Still Pending in Congress
CEO SUMMARY: Both the pending VALID Act and SALSA Act continue to push ahead as 2022 comes to an end. Meanwhile, a new bill centered on the Physician Fee Schedule may protect pathologist payments. These three different proposals share something in common:…
November 21, 2022, Intelligence: Late-Breaking Lab News
In yet another employment ripple from the pandemic, a group of more than 75 pathologists penned a letter to Congress urging lawmakers to retain the option for remote diagnostic work. In the letter, which appeared in the Oct. 20 issue of Nature, the pathologists wrote, “During the COVID-19 pa…
How Genomic Testing Labs Can Improve Their Relationships with Payers
CEO SUMMARY: For payers and health plans, it may be a matter of trust that initially curtails speedy reimbursement of new and novel genomic test claims. A panel …
October 10, 2022 Intelligence: Late-Breaking Lab News
Future regulation of laboratory-developed tests (LDTs) may not be as clear as it once appeared. On Sept. 30, Congress passed a short-term resolution to keep the federal government funded. As part of the move, a proposed bill to increase oversight of LDTs has been sidelined, at least for now, accordin…
Might LDT Regulation Bill Support Be Waning in Congress?
This is an excerpt of an 833-word article in the July 18, 2022 issue of THE DARK REPORT. The full article is available to members of The Dark Intelligence Group. …
Important Court Rulings & Pending New Federal Law
IMPORTANT THINGS ARE HAPPENING WITH COURT DECISIONS AND PROPOSED FEDERAL LEGISLATION that will affect a substantial number of the nation’s clinical laboratories and anatomic pathology groups. In this issue of The Dark Report, you’ll be alerted to those developments we th…
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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