Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
FDA-dtet
Has Your AI Been Validated?
Many artificial intelligence-based medical devices have not undergone clinical validation—but what does this mean for the lab?
Diagnostics Pipeline: Recent FDA Approvals Aim to Make HPV Testing for Women More Accessible
Expansion of use for two assays gives patients the option to self-collect specimens at home and in the clinic, which may help address gaps in screening
FDA Watch: Agency Exempts Dozens of Tests from 510(k) Review
On Dec. 30, 2019, the U.S. Food and Drug Administration (FDA) published a final order exempting dozens of Class I and Class II medical devices that previously required 510(k) submission from 510(k) premarket review
FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to premarket approval in 2019 after issuing just one such warning letter in all of 2018.
Zika Antibody Detection Tests Go from Emergency to Commercial Clearance
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Emerging Tests: New Genetic Tests May Be Better than PSA Screening in Assessing Prostate Cancer Risk
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FDA Watch: Expanded Label Clearance Opens Cologuard to a Younger Market
September was an eventful month for one of the hottest products on the consumer genetic test market, the Cologuard multi-target stool DNA test (mtSDNA) for colorectal cancer screening produced by Exact Sciences. The month started badly with the release of a CMS-sponsored research report finding Cologuard “less effective and considerably more costly” than alternatives. Although Exact Sciences quickly criticized the report and its analytical methodology, its stock took a beating.
Emerging Tests: FDA Breaks New Ground by Clearing EIA Technology-Based Lyme Assays
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LDTs: FDA Cracks Down on Marketing of Non-Approved PGx Medication Response Tests
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FDA Watch: Agency Issues New Guidance on Biotin Interference Testing
From - Diagnostic Testing & Emerging Technologies
On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform…
FDA Greenlights Assays Using New Test Model for Lyme Disease Diagnosis
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Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
