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
Diagnostic Testing and Emerging Technologies
Keeps You Up-to-Date on New Diagnostic Tests, Testing Trends and Opportunities, and Emerging Test Technologies
Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
Computing the Future of the Lab
Computational biology expert Keaun Amani shares his advice and insights on AI and machine learning tools for the clinical lab
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.
Utilization: Study Finds that Distribution of Free Self-Tests Increases HIV Testing & Awareness
Internet distribution of free HIV self-tests can boost testing, promote awareness among high-risk individuals resulting in less incidence of transmitting the disease. These are the key findings of a newly published Centers for Disease Control and Prevention (CDC) study.
Precision Medicine: Are Primary Care Providers Prepared to Interpret Genetic Testing Results?
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Genetic Tests: NCCN Updates Genetic Breast, Ovarian & Pancreatic Testing Guidelines
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Genetic Testing: Proposed New Medicare Coverage Rules for NGS Germline Testing of Early-Stage Cancer Patients
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Emerging Tests: New Study Supports Feasibility of At-Home Urine Prostate Cancer Testing
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Pay rates, vacations while recovering, gig economy
Department of Labor enters final stage of update to ‘regular rate’ rule under FLSA. As we have discussed previously in these updates, the Department of Labor has been working to update the definition
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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