New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
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FDA Watch: Natera, Valar Labs Receive FDA Clearances for Bladder Cancer Tests
Natera’s assay focuses on the need for adjuvant therapy, while Valar’s test stratifies risk of recurrence
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FDA Watch: New RAPID Coverage Pathway Would Enable Some Lab Tests to Pursue Clearance and Medicare Coverage Simultaneously
FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices
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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…
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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…
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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…
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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…
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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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LDTs: Top 10 New FDA Diagnostic Approvals of 2017
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