TAG:
in vitro diagnostic
FDA’s Gottlieb Favors Flexibility with LDTs, NGS
CEO SUMMARY: FDA Commissioner Scott Gottlieb said the FDA wants to reduce the regulatory burden on developers of next-generation sequencing (NGS) and laboratory-developed tests (LTDs). He also wants to give the FDA more flexibility in how it conducts clinical analysis and validation. To d…
Newsmaker Interview: Healthcare’s Transformation Now Bringing Changes to Lab Industry
“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures.” …
Top 10 Lab Stories of 2017 Dominated by Part B Cuts
CEO SUMMARY: In hindsight, 2017 is likely to be remembered as a milestone year that launched several disruptive developments that will reshape the lab industry moving forward. For the clinical laboratory sector this year, CMS confirmed its intent to slash Part B clinical laboratory test price…
Finally, Abbott Buys Alere to Become #1 in POCT
CEO SUMMARY: After nearly two years of legal battles, Abbott Laboratories’ acquisition of Alere concluded on Oct. 3. Despite antitrust requirements to divest several of Alere’s diagnostic businesses to Quidel and Siemens Healthineers, the merger makes Abbott the world’s largest provider…
Proposed Bill in Congress Would Regulate LDTs
CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both …
Philips digital pathology system scores huge success as FDA clears digital path for primary diagnosis
This is an excerpt from a 1,400-word article in the April 24, 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. …
FDA Clears Digital Path for Primary Diagnosis
CEO SUMMARY: Proponents of digital pathology systems and whole slide imaging achieved a milestone on April 12 when the FDA cleared the Philips digital pathology system for sale in the United States. Now pathologists can use the system to perform primary diagnoses and get paid for those pr…
June 13, 2016 Intelligence: Late Breaking Lab News
Life insurers are adopting healthcare big data as part of their underwriting process and clinical laboratory test data has an important role. Quest Diagnostics Incorporated participates in this business line. Huffington Post recently published a story on this topic and ident…
New Lab Industry Trends Require Responses by Labs
CEO SUMMARY: One stark difference between the presentations delivered at last year’s Executive War College and this year’s presentations in New Orleans last week was near-unanimous recognition that the era of fee-for-service payment is soon to end! Speaker after speaker urged the…
Quality Assurance Regs to Tighten for UK Labs
CEO SUMMARY: In the United Kingdom, a window of opportunity has opened for improving the quality assurance activities of pathology and histopathology laboratories. Last week, at the Frontiers in Laboratory Medicine conference, the newly-published “Pathology Quality Assurance Review” w…
CURRENT ISSUE
Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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