Latest News

  • Illumina, Bristol-Myers Announce Diagnostic Collaboration

    Diagnostics World News Brief  Bristol-Myers Squibb and Illumina today announced a collaboration that will use Illumina's next-generation sequencing (NGS) technology to develop and globally commercialize in vitro diagnostic (IVD) assays in support of Bristol-Myers Squibb's oncology portfolio. The companies plan to develop a diagnostic version of the Illumina TruSight Oncology 500 assay to measure potentially predictive genomic biomarkers, including Tumor Mutation Burden (TMB).

    Apr 13, 2018
  • Scott Gottlieb Announces 3 New FDA Guidances Focused On NGS, In Vitro Diagnostic Development

    Diagnostics World | Yesterday, FDA Commissioner Scott Gottlieb announced via Twitter new policies for the Administration he says are designed to “keep pace with fast-moving [next-generation sequencing] technologies.” The three guidances focus solely on NGS and in vitro diagnostic development.

    Apr 13, 2018
  • HudsonAlpha’s Genomic Medicine Conference: Embracing A Brave New World

    Bio-IT World | Coinciding with the Institute’s 10-year anniversary, HudsonAlpha hosted their second Genomic Medicine Conference this week on their campus in Huntsville, Ala. For two and a half days researchers, geneticists and healthcare professionals told their stories about how genomic data has impacted their respective professions and how the data they have been collecting influences their patients.

    Apr 11, 2018
  • Mosquito-Borne Virus Detection Methods Get Smart

    Diagnostics World | It’s an understatement to say that smartphones have become widespread. Today, the global human population stands at over 7 billion, according to the U.S. Census Bureau. Meanwhile, the number of mobile connections circulating on Earth has climbed over 8 billion. And some believe this prevalence of handheld tech tools could help tackle some of the world’s peskiest problems.

    Apr 11, 2018
  • Loxo Oncology, Illumina To Partner On Developing NGS-Based Pan-Cancer Companion Diagnostics

    Diagnostics World Brief | Loxo Oncology and Illumina today announced a global strategic partnership to develop and commercialize a multi-gene panel for broad tumor profiling, resulting in a distributable, next-generation sequencing based companion diagnostic with a pan-cancer indication.

    Apr 10, 2018
  • Diagnostic Technology Is Key To Ensure The Most At-Risk Groups Of HIV Sufferers Aren’t Left Behind

    Diagnostics World Contributed Commentary | Significant steps have been taken towards tackling HIV, which at one point, seemed to be an insurmountable challenge, and now the UNAIDS organisation is targeting zero deaths from HIV or new infections in Africa by 2030—an ambitious aim that would have seemed completely unachievable two decades ago.

    Apr 3, 2018
  • Caris Life Sciences, Quanterix, Intezyne, And More: News From March 2018

    Diagnostics World | March featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Caris Life Sciences, Quanterix, Intezyne, and more.

    Mar 28, 2018
  • Butterfly Network Announces the World’s First Augmented Reality Ultrasound

    Diagnostics World News Brief | Butterfly Network, a project of Jonathan Rothberg, has announced that it has developed a novel augmented reality telemedicine technology on Butterly iQ, the world's first whole-body ultrasound imager. Butterfly iQ is a personal ultrasound device and sells for less than $2,000. Using Butterfly Tele-Guidance technology, an ultrasound expert can remotely guide any user to acquire even the most challenging ultrasound scans, bringing medical expertise to wherever it's needed most.

    Mar 26, 2018
  • Clinical Metagenomics Will Improve Diagnosis Rate For Complex Cases

    Diagnostics World Contributed Commentary | In the research community, metagenomics has yielded new insights into microbial communities and emerging pathogens, giving scientists reams of novel information about everything from optimal soil for crop production to new means of tracking criminal activity. Now, clinical labs are beginning to adopt metagenomics, with consequences that may be just as game-changing for diagnosing and treating patients with infectious diseases.

    Mar 23, 2018
  • FDA Authorizes Blood Test To Aid In TBI Evaluation

    Diagnostics World | The US Food and Drug Administration has granted the De Novo request for the commercialization of Banyan BTI (Brain Trauma Indicator), an in vitro diagnostic blood test to aid in the evaluation of adult patients with suspected traumatic brain injury.

    Mar 21, 2018
  • Xconomy CMS Starts to Cover Broad Cancer DNA Tests Boosting Foundation, Thermo

    Xconomy | The Centers for Medicare & Medicaid Services, which administers the federal Medicare insurance program, will begin covering FDA-approved diagnostic tests that scan tumors for a range of genetic mutations.

    Mar 19, 2018
  • Medial EarlySign Uses Machine-Learning To Predict Which Diabetic Patients Will Suffer Kidney Damage

    Diagnostics World | Medial EarlySign recently announced the results of a clinical data study in which their machine-learning based model was able to analyze Electronic Health Records and identify diabetic patients who are at the highest risk for having kidney disease within one year.

    Mar 19, 2018
  • The Role Of Companion Diagnostics In Drug Development

    Diagnostics World | Representatives of academic institutions, pharma, and biotech companies responded to a recent survey saying that companion diagnostics are vital to personalized medicine.

    Mar 16, 2018
  • SEC Charges Theranos And CEO Elizabeth Holmes With Fraud

    STAT | The charges cap off a remarkable downfall for a once high-flying company that promised to revolutionize the blood testing industry but instead became a parable for Silicon Valley hype and hubris.

    Mar 14, 2018