When Is Genome Sequencing Advisable?
With patient and provider demand for WGS on the rise, what should laboratorians know about ordering and interpreting this testing?
Clinical Diagnostics Insider
(formerly Diagnostic Testing and Emerging Technologies)
Keep up to date on new and emerging diagnostic tests, testing trends and opportunities, and disruptive technologies
AI in Health Care: Balancing Benefits and Barriers
AI can help alleviate the burden on clinical labs—but only with sufficient investment, enthusiasm, and understanding
Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
FDA Watch: Agency Resounds the Alarm on Biotin Test Interference
In early November 2019, the U.S. Food and Drug Administration (FDA) updated a previous safety communication about the potential of biotin to significantly interfere with diagnostic tests. The update reiterates the warning
FDA Unveils New Process for Streamlined Review of IVD Tests Used in Cancer Drug Trials
Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, 2019, the US Food and Drug Administration (FDA) issued final guidance setting out a streamlined process that allows companies to apply
Testing Trends: The Debate Continues Over Regular Colorectal Screening for Average Risk Adults
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Zika Antibody Detection Tests Go from Emergency to Commercial Clearance
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Test Utilization: ‘Cascades of Care’ Cause Wasteful, Unnecessary and Anxiety-Producing Testing
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Emerging Tests: New Genetic Tests May Be Better than PSA Screening in Assessing Prostate Cancer Risk
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Kellison and G2 Intelligence Honor Dr. Sidney Goldblatt
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Emerging Tests: FDA Issues New Guidance on Using NGS Data to Secure Antiviral Drug & CDx Test Approval
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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.
Testing Trends: AMP Creates New Quality Guidelines for PGx Laboratory Testing
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