By Mike O’Brien bio 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 … [Read more...]
FDA WATCH
FDA Watch: Agency Resounds the Alarm on Biotin Test Interference
November 19, 2019
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 … [Read more...]
EMERGING TESTS
FDA Unveils New Process for Streamlined Review of IVD Tests Used in Cancer Drug Trials
November 19, 2019
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 … [Read more...]
Current Issue of DTET
November 19, 2019
Before You Download Please read the following user agreement and confirm your acceptance of the terms before you download DTET content: I agree that I am the the only person who is … [Read more...]
TESTING TRENDS
Testing Trends: The Debate Continues Over Regular Colorectal Screening for Average Risk Adults
November 16, 2019
Should adults age 50 to 75 who are at average risk and show no symptoms of colorectal cancer have regular colorectal screening exams? Last month, a major medical journal came out against regular … [Read more...]
EMERGING TESTS
Zika Antibody Detection Tests Go from Emergency to Commercial Clearance
November 16, 2019
Over the past several years, the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did … [Read more...]
TEST UTILIZATION
Test Utilization: ‘Cascades of Care’ Cause Wasteful, Unnecessary and Anxiety-Producing Testing
November 16, 2019
Experts estimate that $200 billion is wasted annually on excessive testing and treatment. The typical dynamic is a chain reaction: Something “comes up” on diagnostic tests or screenings and triggers … [Read more...]
EMERGING TESTS
Emerging Tests: New Genetic Tests May Be Better than PSA Screening in Assessing Prostate Cancer Risk
November 16, 2019
The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening based on their specific circumstances. The reason that the USPTF does not directly … [Read more...]
Industry News
Kellison and G2 Intelligence Honor Dr. Sidney Goldblatt
November 13, 2019
Dr. Sidney Goldblatt, MD, is the 2019 recipient of the Kellison Public Service Award. Dr. Goldblatt has been founder, medical director and CEO of Molecular Dx; founder and CEO of Goldblatt Systems; … [Read more...]
EMERGING TESTS
Emerging Tests: FDA Issues New Guidance on Using NGS Data to Secure Antiviral Drug & CDx Test Approval
October 17, 2019
Next generation sequencing (NGS) data supporting resistance assessments is crucial to developing and gaining FDA clearance for new antiviral drugs and related companion diagnostic tests (CDx). Now the … [Read more...]
