Latest News

  • Racial Impacts, Inflammation Markers, Two New Saliva Tests: COVID-19 Updates

    Diagnostics World News | Census data shows COVID-19 follows HIV patterns of racial segregation, how virtual imaging studies can help, inflammation markers that predict severe disease, and models of early transmission. Plus, two EUAs for saliva tests and back-to-work testing.

    Aug 28, 2020
  • Lessons Learned From A Pandemic: Next Generation Dx Summit Day Two

    Diagnostics World News | Day two of the Next Generation Dx Summit was highlighted by a spirited panel discussion on the lessons learned during the pandemic, as well as some practical guidance on the development of next-generation diagnostics.

    Aug 26, 2020
  • New CMS Rules For Nursing Homes, Testing, Reporting COVID-19

    Diagnostics World News | Yesterday, the Centers for Medicare & Medicaid Services (CMS) announced regulatory changes that require nursing homes to test staff and offer testing to residents for COVID-19. Laboratories and nursing homes using point-of-care testing devices will be required to report diagnostic test results as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The new rules also require hospitals to provide COVID-19 cases and related data to the U.S. Department of Health and Human Services (HHS).

    Aug 26, 2020
  • Updates on CDx, Feedback from FDA: Next Generation Dx Summit Day One

    Diagnostics World News | At day one of the Next Generation Dx Summit, MD Anderson Cancer Center highlighted “unprecedented opportunities” for blood-based biomarkers in cancer detection, Merck weighed in on the regulatory environment for companion diagnostics, FDA gave an update on selected precision oncology initiatives of the agency, and more.

    Aug 25, 2020
  • Adaptive Biotechnologies, Strata Oncology, And More: News From August 2020

    Diagnostics World News | August featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Adaptive Biotechnologies, Strata Oncology, and more.

    Aug 24, 2020
  • HHS Rescinds FDA’s Role in Regulating Lab-Developed Tests

    Diagnostics World News | After years of uncertainty over the future of laboratory developed tests (LDTs), the Department of Health and Human Services (HHS) has determined the FDA does not have the authority to regulate lab-developed tests for any condition according to a rescission posted on Wednesday.

    Aug 21, 2020
  • Weakness of ICD-10 Codes, Role of Mobile Monitoring, Antibodies For Sale: COVID-19 Updates

    Diagnostics World News | Disturbing uptick in partner violence during the COVID-19 pandemic, ICD-10 codes insufficient for capturing COVID-19 related symptoms, the role of mobile health technologies to monitor patients at home, the role of children in community spread, and impact of different types of antibodies. Plus, neutralizing antibodies for sale.

    Aug 21, 2020
  • Race Matters When It Comes To Risk Calculators For Heart Disease

    Diagnostics World News | Measuring the concentration of high-density lipoprotein (HDL) cholesterol particles is a more reliable predictor of heart disease and stroke than the standard metric of total HDL cholesterol—that is, unless you’re trying to assess the risk of a heart attack in someone who is black. Then, surprisingly, neither method is helpful.

    Aug 20, 2020