TAG:
FDA
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…
Pandemic Helped Lab with Hospital Leaders
CEO SUMMARY: Growth at Atrium Health during the COVID-19 pandemic elevated its clinical laboratory’s profile with medical leaders and health system administrators. What followed was a new spirit of collaboration that led to lab involvement in cost savings efforts, such as improved…
Public IVD Companies Report Q4, Full-Year 2022 Earnings
YEAR-END AND Q4 EARNINGS REPORTS FROM MAJOR IN VITRO DIAGNOSTICS (IVD) COMPANIES pointed to a welcome sign of core diagnostic business rebounding. That’s the good news for IVD firms. The bad news? All of the SARS-CoV-2 testing revenue that th…
Fujifilm Buys Inspirata’s Digital Pathology Assets
CEO SUMMARY: Fujifilm’s acquisition of the digital pathology technologies and clients of Inspirata marks the departure of one early entrant into the digital pathology market. At the same time, executives from Fujifilm Healthcare Americas Corporation discuss why the company is incr…
Eight Macro Trends for Clinical Labs in 2023
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
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 …
Top Public IVD Companies Report Q3/Q4 2022 Earnings
IT WAS A MIXED BAG OF THIRD QUARTER FINANCIAL RESULTS for the nation’s largest in vitro diagnostics (IVD) manufacturers, with COVID-19 testing volume a contributing factor. Fluctuating demand for SARS-CoV-2 testing proved perplexing, as some IV…
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:…
Newsmaker Interview: Director of CDC’s Division of Laboratory Systems Talks COVID-19, CLIA, and More
CEO SUMMARY: In this exclusive interview, Reynolds Salerno, PhD, the Director of the Division of Laboratory Systems at the CDC, offers insightful comments about the federal agency’s response to the SARS-CoV-2 pandemic, what went right during public health efforts, and lesson…
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 …
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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