Latest News

  • A Diagnostic DNA Sequencer for the Chinese Market

    Bio-IT World | Direct Genomics of Shenzhen is bringing back the sequencing technology of the former Helicos Biosciences, hoping to give it a second life as an easy-to-use, multi-purpose diagnostic instrument.

    Oct 30, 2015
  • Information is Power Initiative Launches

    Diagnostics World News Brief | The "Information is Power" initiative from Kailos Genetics and the HudsonAlpha Institute launches today. The first free test kits will be given out this evening at HudsonAlpha's Tie the Ribbons October breast cancer fundraising event, but men and women in Huntsville and Madison County, Alabama, can go online now to check their eligibility for free or discounted test kits.

    Oct 29, 2015
  • Enrollment Begins at UCSF in Study of Avelas Cancer Illuminator

    Xconomy | San Diego's Avelas Biosciences says today that UC San Francisco has begun enrolling women who face breast cancer surgery in a clinical trial for AVB-620, a diagnostic agent that helps surgeons differentiate cancerous tissue from healthy in real time.

    Oct 29, 2015
  • FDA Intends to Make Autosomal Recessive Carrier Screening Exempt

    Diagnostics World Today the Food and Drug Administration announced its intent to make autosomal recessive carrier screening exempt from premarket regulatory requirements. The notice was posted today online in the Federal Register and will be open for comment until November 27.

    Oct 27, 2015
  • Theranos Releases Point-by-Point Rebuttal

    Diagnostics World News | True to her word yesterday, Elizabeth Holmes’ company, Theranos, has released a 16-page rebuttal to the Wall Street Journal article published last week.

    Oct 22, 2015
  • 23andMe Will Resume Giving Users Health Data

    The New York Times | The genetic-testing company stopped providing health information in 2013 after the F.D.A. ordered it to prove the accuracy of results. Now it will provide carrier status information on 36 diseases with FDA approval. 

    Oct 21, 2015
  • American Cancer Society in a Shift Recommends Fewer Mammograms

    The New York Times | The group says women should start having mammograms at 45 and continue yearly until 54; it previously recommended mammograms and clinical breast exams every year, starting at 40.

    Oct 20, 2015
  • Theranos Has Struggled With Blood Tests

    Diagnostics World Roundup | Theranos, the Silicon Valley lab led by Elizabeth Holmes, is valued at $9 billion but the Wall Street Journal reports that the company isn't using its technology for all the tests it offers.

    Oct 15, 2015
  • Ancestry.com in Talks with FDA on 23andMe-Style Health Service

    The Verge | Tim Sullivan, CEO of Ancestry.com, tells The Verge that his company has a larger database of genetic information than 23andMe, and he's prepared to turn it toward tests for estimating genetic disease risks.

    Oct 14, 2015
  • Kailos Offers PGxComplete Test for $99

    Diagnostics World Brief | Kailos Genetics has announced the release of PGxComplete, a comprehensive, full panel, gene-based test offered at $99 through November 30, 2015. The Huntsville, Ala.-based company earlier announced a landmark effort with the HudsonAlpha Institute to offer free BRCA screening to 30-year-old women in Northern Alabama.

    Oct 14, 2015
  • New Test Predicts Teens’ Future Risk of Heart Disease

    UVA Today | The test, developed by doctors at U.Va. and West Virginia University, gives teens an early warning of future problems, but with plenty of time to change behaviors and lower the risks.

    Oct 9, 2015
  • Micro-Scale Optics Points to New Point-of-Care Tests for Ebola, Influenza

    Diagnostics World | The UC Santa Cruz lab of Holger Schmidt has published a pair of papers showing that they can identify viral particles and RNA on a thumbnail-sized chip. The research is based on the field of optofluidics, guiding light through liquid channels etched in tiny silicon devices.

    Oct 5, 2015
  • Announcing the 26-Hour Diagnostic Genome

    Bio-IT World Stephen Kingsmore and his colleagues at the Center for Pediatric Genomic Medicine at Children’s Mercy in Kansas City, announced 26-hour diagnostic whole genome sequencing in a paper published yesterday in Genomic Medicine, an improvement over the 50-hour whole genome sequencing the group published in 2012. The paper is published just one day after Kingsmore took his new post as President and CEO of the Rady Pediatric Genomics and Systems Medicine Institute at Rady Children’s Hospital in San Diego.

    Sep 30, 2015
  • FDA Turns Its Eye on Pathway's 'Direct-to-Consumer' Cancer Test

    Diagnostics World | This Thursday, the FDA sent a letter to Pathway Genomics warning the company that a newly introduced test, a liquid biopsy to find early-stage cancer in apparently healthy people, has not been clinically validated and could be harmful to public health. The letter not only calls attention to the shaky evidence for this test's accuracy, but also asserts the FDA's authority over a whole category of tests in a regulatory gray area.

    Sep 25, 2015
  • Matchmaker Exchange Platform Launched to Match Rare Disease Patients

    Diagnostics World Brief | Brigham and Women’s Hospital announced this morning the launch of the Matchmaker Exchange, a way for the rare disease community to share information and find new connections. Matchmaker Exchange connects databases of genetic information and symptoms that physicians and investigators can “match” with a patient’s rare disease.

    Sep 24, 2015
  • Smartphone Device Can Quickly Diagnosis Cancer

    Massachusetts General Hospital | MGH researchers have developed a device that can turns a smartphone camera into a microscope to diagnosis cancer and, in the process, reduce patients' anxiety and improve access to care. The next step is a clinical trial in Africa.

    Sep 17, 2015
  • 5 Questions Euan Ashley on Diagnosing the Undiagnosable

    Stanford | Today NIH launches its Undiagnosed Disease Network under the guidance of heart specialist Euan Ashley. Ashley sat for a Q&A with his home institution's news group.

    Sep 16, 2015
  • Memorial Sloan Kettering, Illumina Announce Collaborative ctDNA Research Plan

    Diagnostics World Brief | Memorial Sloan Kettering Cancer Center and Illumina this morning announced a collaboration to conduct research studies that are critical to understanding the biology of circulating tumor DNA (ctDNA). The studies aim to inform the development of new strategies to diagnose and monitor cancer and to help establish ctDNA as an important marker in the study and eventual treatment of cancer.

    Sep 16, 2015
  • WuXi NextCODE Launches Partnership with Chinese Children's Hospital

    Diagnostics World Brief | Less than a year after NextCODE Health was bought by Chinese services group WuXi PharmaTech, WuXi NextCODE has announced a partnership with the Children’s Hospital of Fudan University (CHFU) to bring genomic testing to clinical use in China for the first time.

    Sep 16, 2015