Latest News

  • Moving From Why To How With Personalized Medicine Technologies

    Diagnostics WorldOncologists often make decisions about diagnostic tests with very little information to go on, and the dearth of high-quality evidence has made it difficult for both doctors and institutions to advance personalized medicine without a roadmap for overcoming the challenges, which the Personalized Medicine Coalition (PMC) has been developing. At the recent Next Generation Dx Summit, speakers explored how oncologists choose and evaluate such tests.

    Sep 8, 2020
  • Speed To Answers, Viral Spreaders, Symptom Data Challenge: COVID-19 Updates

    Diagnostics World News | A CRISPR-based assay and smartphone-based molecular test, the role of children in viral spread, using pressure to concentrate samples, a patient scoring system, timetable on retesting, two tests are better than one, and deep dives on older patients. Plus, the COVID-19 Symptom Data Challenge and nine more companies get NIH grants to scale up COVID-19 testing.

    Sep 4, 2020
  • Rules of the Regulatory Road For Companion Diagnostics

    Diagnostics World News | The regulatory framework around drug and diagnostic co-development, and how to overcome the inevitable hurdles, was the subject of multiple presentations at the 12th Annual Next Generation Dx Summit held virtually last week.

    Sep 1, 2020
  • 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
  • Older Adults Being Left Behind In The Migration To Telemedicine

    Diagnostics World News | More than one-third of U.S. adults over age 65 may face difficulties seeing their doctor via telemedicine, for reasons ranging from poor hearing and eyesight, dementia, to owning no internet-enabled devices. To build a more accessible telemedicine system will require taking steps to overcome both disability and the high prevalence of inexperience with technology in the senior population.

    Aug 18, 2020
  • AI-Based Tools Predict COVID-19 Disease Severity

    Diagnostics World | As health systems across the globe continue to deal with large numbers of COVID-19 cases, new and emerging technologies may be able to help in this regard.

    Aug 18, 2020
  • COVID-19 News: NIST Shares Synthetic Virus For Test Validation, Published Results of Retesting, More

    Diagnostics World News | New COVID-19 risk model developed by Cleveland Clinic and published findings from a retesting study. Plus, symptom trackers deployed by colleges for Back to School and quantified synthetic virus fragments available from NIST.

    Aug 14, 2020
  • PacBio, Asuragen Collaborate on Carrier Screening Assays

    Diagnostics World News | Pacific Biosciences and Asuragen have launched a clinical research collaboration aimed at developing molecular assays based on PacBio’s Single Molecule, Real-Time (SMRT) Sequencing technology.

    Aug 11, 2020
  • The Long Game On Telehealth

    Diagnostics World News | As the pandemic has dragged on, medical practices everywhere have also started thinking seriously about how to better fit telehealth into their patient care workflow over the long term.

    Aug 11, 2020
  • FDA Approves First COVID-19 Serology Tests, Other News

    Diagnostics World News | In a report in the Journal of Molecular Diagnostics, researchers describe a cheaper, rapid, and accurate pooling strategy for the RT-PCR-based detection of SARS-CoV-2 in clinical samples. Elsewhere, the U.S. Food and Drug Administration has authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood. This, plus more, is included in this week’s COVID-19 news and research in the diagnostics industry.

    Aug 7, 2020
  • Next Generation Dx Summit Goes Virtual Offering Even More Content, Opportunities

    Diagnostics World NewsThe Next Generation Dx Summit is going virtual later this month, offering a rich content experience with even more opportunity to learn through on demand sessions, live panel discussions, and plenty of digital networking events including a robust exhibit hall.

    Aug 6, 2020
  • Follow the Money: Pan-Cancer Liquid Biopsy Investments, CBC from Finger-Stick Blood

    Diagnostics World News | Big investments in liquid biopsy this month, with $257M for a pan-cancer test from Thrive Earlier Detection and another $72M for complete blood count analysis from finger-stick blood. COVID-19 gets diagnostics funding too, pushing toward six million daily tests.

    Aug 5, 2020
  • MUSC Stretching ICU Surge Capacity To Statewide Proportions

    Diagnostics World News | The Medical University of South Carolina is trying to quickly stand up a telemedicine system to increase ICU surge capacity across the state during the ongoing COVID-19 outbreak.

    Aug 4, 2020