HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
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FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
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New Zika Blood Testing Guidance Effective Immediately
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FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory
From - National Intelligence Report
On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four…
Genomic Tests: Two New Assays Win FDA Breakthrough Device Designation
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New FDA Guidance Aims to Ease Approval for New NGS Tests—But It Probably Won’t Work
From - National Intelligence Report
Test makers have long complained about the FDA's unwillingness to embrace technology and diagnostics advances. But on April 13, the agency took steps to address…
Case of the Month: $33.2 Million Alere Settlement Sends Warning Shot Across Bow of LDT & DX Device Makers
From - National Intelligence Report
One of the reasons Abbott Laboratories got cold feet about consummating the $5.3 billion Alere acquisition was concern over the legal proceedings against the…
FDA Watch: Agency Approves DTC Genetic Breast Cancer Test—But Attaches Strings
From - National Intelligence Report
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test…
FDA Watch: Extra Time for Comments on CLIA IVD Waiver Proposals
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FDA Watch: Labs Warned that Biotin Interferes with Test Accuracy
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