Latest News

  • Regulators Propose Banning Theranos Founder Elizabeth Holmes for at Least Two Years

    WSJ | Theranos founder Elizabeth Holmes and President Sunny Balwani faces possible ban after Centers for Medicare and Medicaid Services said company failed to fix problems in blood testing with Edison machines, other areas.

    Apr 14, 2016

  • Researchers Develop Smartphone Accessory That Can Diagnose Ear Infections With High Accuracy

    Medical Daily | A publication in EBioMedicine details a low-cost, smartphone-connected otoscope that can test for ear infections using automated image analysis, with similar accuracy to physicians using standard otoscopes.

    Apr 11, 2016

  • Invitae Expands Genetic Testing Menu as Cheap, Inclusive Tests Are on the Rise

    Diagnostics World | Invitae—which began life in 2012 promising an “all-in-one” genetic test but has since become a piecemeal provider of gene panels—has launched a new series of pediatric tests, focusing on rare, high-impact variants.

    Apr 1, 2016

  • Report Shows Theranos Testing Plagued by Problems

    The New York Times | Federal regulators say the blood-testing company used poorly trained workers and mishandled blood samples.

    Apr 1, 2016

  • Finally Some Theranos Data. But Not From Theranos

    Forbes | There's a central dictum in engineering, in medicine, in life, at which Theranos, the controversial blood test company, has constantly failed. "In God we trust," the mid-century statistician William Edward Deming quipped. "All others bring data." Now, once again, Theranos does not have data to bring. But researchers at the Icahn School of Medicine at Mt. Sinai have done their own analysis of Theranos' tests.

    Mar 30, 2016

  • How Veritas Genetics Plans to Make Its $999 Whole Genome Stick

    Bio-IT World | The myGenome service from Veritas Genetics, a $999 screen that includes a whole genome sequence and reports on an expansive number of health conditions, is running up against both the financial and regulatory limits of what genetic testing can offer today.

    Mar 28, 2016

  • Lexington diagnostic company Quanterix looks to cancer test with $46M raise

    Boston Business Journal | ​Two months after announcing an expansion into Asia, Lexington diagnostic company Quanterix will set its sights on developing a cancer test with $46 million in Series D funding.

    Mar 25, 2016

  • Paper Diagnostic Tests Could Save Thousands of Lives

    Scientific American | Paper sensors could detect chemical and biological molecules easily in the field, but lack of funds and commercial partners mean many advances will languish in the lab.

    Mar 25, 2016

  • Tute, Newborn Screening Ontario Announce Plan for NGS Testing Panel

    Diagnostics News Brief | Newborn Screening Ontario (NSO), Tute Genomics, and UNIConnect this morning announced a project to establish the informatics infrastructure for NSO's new next-generation sequencing (NGS) testing panel. Terms and conditions of the agreement were not disclosed.

    Mar 22, 2016

  • Biocept's Dual Platform for Liquid Biopsies

    Diagnostics World | A growing number of companies are creating their own custom platforms to capture and analyze circulating tumor cells or circulating tumor DNA, as co-diagnostic tools in the treatment of cancer. Biocept of San Diego is one of the few companies with solutions for analyzing both types of cancer material in whole blood.

    Mar 18, 2016

  • Variant Classification Case to Test Culpability of Diagnostics Labs

    GenomeWeb A lawsuit filed against Quest Diagnostics subsidiary Athena Diagnostics could have far reaching repercussions for the diagnostics testing industry. If the case proceeds, a jury will have to decide whether there was sufficient evidence in the literature in 2007 for Athena Diagnostics to determine a pathogenic link between mutation and disease. The decision would set industry-changing precedent.

    Mar 17, 2016

  • CDC Tracking Origins of Mysterious Wisconsin Outbreak

    Wired | Since November, more than 50 people in Wisconsin have one by one fallen ill with an obscure kind of bacteria called Elizabethkingia.

    Mar 17, 2016

  • Researchers Say PulseNet Reaches Far Beyond Outbreak Control

    Food Safety News | A group of academics has published a study on the impacts of PulseNet, the national network of disease data for monitoring food safety threats.

    Mar 16, 2016

  • Notes from the 2016 Molecular Medicine Tri-Conference

    Diagnostics World | The 23rd annual Molecular Medicine Tri-Conference convened last week in San Francisco, Calif. The six-day event featured showcases of exciting new diagnostic products, and presentations that addressed advances in fast-growing fields like cell-free DNA assays and point-of-care testing.

    Mar 16, 2016

  • FDA Sends Three Letters Over Unapproved Zika Diagnostics

    RAPS | FDA is enforcing its oversight of Zika diagnostics with letters to two labs and two Texas hospitals for marketing "high risk" unapproved diagnostic tests for the virus.

    Mar 16, 2016

  • Xcell's New Incubator Promises Lifelike Conditions for Tests on Primary Cells

    Diagnostics World | Last week, at the Molecular Medicine Tri Conference in San Francisco, Calif., Xcell Biosciences announced the commercial launch of the Avatar System, a cell incubator designed to mimic real-life microenvironments inside the human body.

    Mar 14, 2016

  • When baby is due genetic counselors seen downplaying false alarms

    New England Center for Investigative Reporting | About 14% of genetic counselors work directly for testing companies. What does that mean for the accuracy of diagnostic tests?

    Mar 7, 2016

  • The Nanolight Revolution is Coming

    Nature News | Virus-sized particles that fluoresce in every colour could revolutionize applications from television displays to cancer treatment.

    Mar 3, 2016