Diagnostics Pipeline: 2024 Trends in FDA Approvals
In vitro diagnostic products approved by the U.S. Food and Drug Administration in 2024 show a continued move toward rapid and point-of-care tests
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
A Closer Lab-Patient Connection
Patient access to data from the clinical lab is increasing. What does this mean for those generating it?
New and Improved: The Latest Research in Disease Screening
New ideas and innovations look beyond conventional screening options to facilitate improved disease diagnosis and patient outcomes
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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Test Utilization: New Guidelines Recommend Basing Routine Colorectal Cancer Screening on Risk Rather than Age
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