Latest News

  • Widening Scope of Noninvasive Prenatal Testing Triggers Debate

    MIT Technology Review | Doctors and genetic counselors question the need for blood tests during pregnancy that are expanding from conditions like Down syndrome to extremely rare and poorly understood microdeletions.

    Sep 1, 2015
  • Exosome Diagnostics' Strategic Reimbursement Model for Cancer Genomics

    Boston Business Journal | A new Cambridge diagnostic-maker with a test aimed at identifying genetic markers of cancer is taking a different tack from Foundation Medicine in hopes of an easier path to getting insurance reimbursement.

    Aug 28, 2015
  • Blood Tests May Soon Diagnose Concussion

    MIT Technology Review | Quanterix and Banyan Biomarkers both say they've identified proteins that could lead to a blood test to quickly diagnose concussions. The proteins seem to increase in blood corresponding with the severity of brain injury. Banyan is in the midst of a clinical trial now.

    Aug 28, 2015
  • Black Box Diagnoses

    New Scientist | As academics and commercial companies design machine learning programs to diagnose disease based on analysis of medical images, doctors and patients may have to learn to trust "black boxes" that can give medical answers but can't explain their reasoning.

    Aug 26, 2015
  • Deep Genomics Sets Sights on Clinical Testing

    Diagnostics World | The idea is beautiful: read the text of DNA and understand the workings of the body. Brendan Frey isn’t claiming it’s simple, but with advanced machine learning and expertise in cell and genome biology, Deep Genomics is chasing the vision. And the first application will be the clinical genetic testing market.

    Aug 24, 2015
  • In-App Genomics: Pathway Genomics Sells Genetic Test Through App

    Diagnostics World | Now you can get genomics test results with an easy in-app purchase. Pathway Genomics is offering its Pathway Fit genetic test for purchase through the Pathway app, further lowering the barrier to test access.

    Aug 21, 2015
  • Association for Molecular Pathology Puts Forth New Plan to Regulate Laboratory Developed Tests

    Diagnostics World | As the FDA moves forward with its plan to regulate laboratory developed tests, Roger Klein, Chair of the Association for Molecular Pathology's Professional Relations Committee, tells Diagnostics World about his organization's alternative plan to modernize the way these tests are regulated while keeping their oversight under the current CLIA program.

    Aug 20, 2015
  • Myriad Genetics New CEO, New Direction

    AJMC | Myriad Genetics' new CEO, Mark Capone, is shifting the company's futures in molecular diagnostics, and competing with a broad new field of companies like Color Genomics and more.

    Aug 14, 2015
  • Scanadu Scout Measures Vitals at the Temple

    Computerworld   The handheld Scanadu Scout measures vital signs by placing the device at your temple for about 30 seconds, then sends the results to your smartphone.

    Aug 12, 2015
  • Insurers to Begin Covering Continuous Glucose Monitors Through Pharmacies

    MD+DI | Dexcom, a manufacturer of continuous glucose monitors, has announced that UnitedHealthcare and Anthem will both allow patients enrolled in their plans to pick up continuous glucose monitors at pharmacies with their other prescriptions, rather than ordering them from third-party distributors.

    Aug 7, 2015
  • Ruling Out Cancer

    Xconomy | The overdiagnosis of cancer, thanks to routine screenings that pick up false positives, is starting to get attention as a major health concern — but while most people addressing the problem want to reduce screenings, some are interested in the technological approach of creating new tests that can reliably rule out a diagnosis of cancer.

    Aug 6, 2015
  • Fluoresentric on the Right Pitch to Capitalize a Diagnostic Technology

    Diagnostics World | Fluoresentric, creator of a rapid DNA amplification technique for handheld diagnostics, won a unanimous vote from the judges at the Molecular Medicine Tri-Conference Swimming With The Sharks event this February. As the deadline for submissions to the 2016 competition approaches, CEO William Olson shares his latest plans for the company and his advice for winning over investors.

    Aug 4, 2015
  • Silk-Based Microfluidics Form Basis of Low-Cost Test Strips

    WIRED | At Achira Labs in India, researchers are spinning diagnostic sensors out of silk.

    Jul 28, 2015
  • Liquid Biopsy Developed for Pancreatic Cancer

    Diagnostics World | In a win for liquid biopsy, researchers from University of Texas MD Anderson Cancer Center have identified a protein that could spot pancreatic cancer in its early stages. The protein, which is shed from cancer cells, could serve as a target for early stage diagnostic tests for several hard-to-diagnose cancers.

    Jul 27, 2015
  • India's MedGenome Gets $20m from Sequoia Capital

    Diagnostics World Brief | MedGenome of Bengaluru, India announced a $20 million Series B investment from Sequoia Capital. The investment will support MedGenome in accelerating the expansion of its portfolio of genetic tests, enhancement of sequencing facilities in India and the US, and expanding its collaborative network with specialty hospitals, clinics, and genomic research institutions in India.

    Jul 24, 2015
  • FDA approves diagnostic test to differentiate between types of HIV infection

    FDA News | The U.S. Food and Drug Administration has approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first FDA-approved diagnostic that differentiates between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens.

    Jul 24, 2015
  • Theranos secures FDA waiver to take its blood tests out of the lab

    mobihealthnews | Theranos has been granted a CLIA waiver for its herpes simplex 1 virus test. The move is the first step for Theranos toward mobile health.

    Jul 20, 2015
  • What Comes Next for Direct-to-Consumer Genetics?

    Bio-IT World | After receiving FDA clearance for a single carrier screening test this February, 23andMe has promised to release a new health product to its customers later this year. But regulations are sure to change the types of genetic tests available on the direct-to-consumer market — and lead some to look for alternative ways to expand public access to useful genomic information.

    Jul 16, 2015
  • Ancestry Launches AncestryHealth, Reports 1 Million DNA Database

    Diagnostics World | Ancestry today announced the launch of AncestryHealth, a new entity and resource to empower consumers with important health insights to help promote wellness, prevent illness, and support healthier living. The company named Cathy A. Petti, MD, as AncestryHealth’s Chief Health Officer. At the same time, AncestryDNA announced that it has tested more than one million people with its $99 microarray tests.

    Jul 16, 2015
  • Companion Diagnostic Approved for Iressa in NSCLC

    Diagnostics World Brief | Today, the U.S. Food and Drug Administration announced its approval of Iressa (gefitinib) for the first-line treatment of specific patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.

    Jul 13, 2015