Diagnostics Pipeline: Testing for Intestinal Parasites Takes Step Forward
The EasyScreen assay received 510(k) clearance from the Food and Drug Administration earlier this year–but with a catch
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 Genomics: The Next Generation
How artificial intelligence and machine learning tools stand to benefit clinical labs throughout the genomics pathway.
Evolving Regulations and Guidelines in Genetic Testing
Understanding the regulatory landscape of genetic and genomic testing, and its impact on clinical practice
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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Innovation: Breathalyzer May Offer Reliable, Easier Alternative to Blood-Based Opioid Detection
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Inside the Diagnostics Industry: Quest-hc 1 System Leverages Lab Data to Help Providers Monitor Test Utilization
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New Study Suggests Blood Testing May Be Capable of Diagnosing PTSD
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Laboratory Information Systems (LIS): What You Need To Know To Get Paid
By Sean McSweeney bio
Today, laboratory billing claims require more and more data to successfully get paid.
One of the biggest reasons your claims may be getting denied is because…
Inside the Diagnostics Industry: New Government BRCA Test Guidelines Are a Mixed Bag for Genetic Testing Labs
From - Diagnostic Testing & Emerging Technologies
The US Preventive Services Task Force (USPSTF) issued updated recommendations for BRCA-related cancer risk assessment…
Emerging Tests: FDA Breaks New Ground by Clearing EIA Technology-Based Lyme Assays
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