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Theranos Names Quality, Compliance Execs
| Diagnostics World Brief | Theranos continues to rearrange deck chairs in hopes of righting the ship. Today the company announced the appointment of two new executives to lead the company’s regulatory, quality and compliance efforts. Both are reporting to Theranos CEO Elizabeth Holmes, who earlier this month was banned from owning or operating a medical laboratory for two years. more

New Draft Guidances Highlight Oversight of Next Generation Sequencing (NGS)-Based Testing
| Diagnostics World  On July 8, the Food and Drug Administration (FDA) released two pivotal draft guidances on the emerging role of next generation sequencing (NGS)-based in vitro diagnostics (IVDs). The technology is becoming the go-to method for quick determination of gene variants that might be causative for an array of diseases, such as breast cancer, colon cancer, and muscular dystrophy. Each draft guidance has a different purpose, but both emphasize using best practices and building quality into the processes of using NGS- based IVDs so they have clinical validity. more

The White House Is Pushing Precision Medicine but It Won’t Happen for Years
| MIT Technology Review | For starters, it's too expensive and the science isn't advanced enough. more

The Pan-Cancer Screen Still Early for Prime Time
| Xconomy | Imagine you could go to your doctor once a year for a blood test that would detect nearly every common type of cancer at an early stage. A lot of companies are working on that type of molecular diagnostic, but is it still too early to expect that test? more

JAX, AMA, Scripps Launch Genomic Education for Physicians
| Diagnostics World | The American Medical Association (AMA), in partnership with Scripps Translational Science Institute (Scripps) and The Jackson Laboratory (JAX), have announced a new online program aimed at educating physicians and other health care professionals on the benefits and limitations of genetic testing and when it is appropriate to incorporate it into their practices. more

Illumina Reanalyzes Prenatal Screening False Positives
| New England Journal of Medicine | In a letter to the editor, Diana Bianchi and two Illumina scientists present updated screening test results for the CARE cohort using updated technology, and finds that there were both technological and biological reasons for false positives more

Prostate Diagnostics, Medical Genetics in Hong Kong, Family Genomics
| Diagnostics World News | Diagnostic news and product launches include prostate cancer diagnostic test gets expanded coverage, Baylor University partners on a Hong Kong center for medical genetics, and Sure Genomics launches a family health app. more

Theranos Founder Elizabeth Holmes Is Barred From Running Lab for 2 Years
| The New York Times | U.S. regulators also revoked the operating license of a Theranos lab and levied a fine. The sanctions were a major setback for the once high-flying blood-testing start-up. more

Functional Finds: Building a Database for Variant Lookup
| Diagnostics World Ranomics is capturing attention with its database of genomic variants. Counting BGI and Veritas among its new customers, the Toronto-based biotech startup plans to model and test every missense mutation to make genetic tests "more accurate and more conclusive than ever." more

MyGene2 Fills a Gap in Gene Discovery for Mendelian Conditions
| Diagnostics World News | The introduction of exome and whole-genome sequencing in 2010 has accelerated the discovery of genes underlying Mendelian disorders. However delineating new Mendelian conditions by comparing phenotypic traits across families is still challenging, especially with limited sharing of health and genetic data among researchers. Researchers at the University of Washington have launched a new data sharing platform to bring family expertise to the table. more

Non-profit Research Accelerator Curable to Host its 2016 GAME CHANGER Gala and Mike Ditka Day in Pittsburgh on July 30
| PITTSBURGH, PA - Jul 21, 2016 - Curable, a non-profit research accelerator that applies engineering approaches to medicine, today announced that its annual GAME CHANGER Gala will be held from 5:30-10 p more

Indivumed and Definiens Partner to Unlock the Power of Tumor Tissue for Drug Discovery and Development
| MUNICH, GERMANY - Jul 19, 2016 - Definiens, the pioneer in Tissue Phenomics solutions for diagnostics development and commercialization and Indivumed, GmbH, based in Hamburg, Germany announced today a strategic partnership to offer a unique combination of tissue-based biomarker validation and assay development with Definiens Cognition Network Technology® for image analysis and data mining more

SeraCare and NIST Partner on Development of Circulating Tumor DNA Reference Standards for Diagnostics
| MILFORD, MA - Jul 14, 2016 - SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers, and the U more

Non-profit Research Accelerator SAVE JON Relaunches as Curable
| PITTSBURGH, PA - Jul 6, 2016 - SAVE JON, a non-profit research accelerator that applies engineering approaches to medicine, today announced that it is relaunching as Curable more

Bioo Scientific Launches BRCA1/2 Amplicon Panel for Detection of Somatic Mutations in FFPE Samples
| AUSTIN, TX - Jun 27, 2016 - Bioo Scientific recently launched the NEXTflex™ BRCA1 and BRCA2 Amplicon Panel for FFPE Illumina-Compatible Sequencing, for the detection of clinically relevant somatic mutations in DNA isolated from FFPE samples, to facilitate variant discovery and confirmation more

CHI Announces the Inaugural DNA Forensics Conference, August 23-24, 2016, Washington, DC
| NEEDHAM, MA, UNITED STATES - May 26, 2016 - Cambridge Healthtech Institute (CHI) announces its inaugural DNA Forensics conference will take place on August 23-24, 2016 at the Hyatt Washington Hotel in Washington, DC-as part of the Next Generation Dx Summit more

Quanterix Opens Call for Proposals for Second Annual Accelerator Grant Program Focused on Oncology and Liquid Tumor Biopsy Technology
| BOSTON, MA, UNITED STATES - May 20, 2016 - Quanterix Corporation, a leader in the transformation of healthcare through its ultrasensitive single molecule testing capabilities, today announced the recipient of its first annual Accelerator Grant Program and a call for proposals for its second grant, focused on oncology research more

Definiens’ Symposium Finds Tissue Context of Tumor is Key to Cancer Immunotherapy Success
| MUNICH, GERMANY - May 10, 2016 - Definiens, the pioneer in Tissue Phenomics® solutions for diagnostics development, has announced findings from the International Symposium, a sold-out gathering of international researchers and clinicians on April 27-28 in Boston, Massachusetts to discuss advancements in oncology and the application of Tissue Phenomics more

Novigenix publishes multi-center study of Colox(R) in Clinical Cancer Research
| LAUSANNE, SWITZERLAND - May 9, 2016 - Novigenix SA today announced the publication of a clinical validation study of Colox in the highly ranked journal  Clinical Cancer Research more

| LONDON, UK - Mar 21, 2016 - ~~For immediate release  21 March 2016 ANGLE plc (“the Company”) BARTS PATIENT DATA DEMONSTRATES POTENTIAL OF PARSORTIX FOR PROSTATE CANCER DETECTION CLINICAL APPLICATION Potential for a simple blood test to not only detect prostate cancer but also to assess the aggressiveness of the disease allowing risk stratification to active surveillance or intervention ANGLE plc (AIM:AGL OTCQX:ANPCY), the specialist medtech company, is delighted to announce that the results of Barts Cancer Institute’s ongoing work with ANGLE’s Parsortix system have provided evidence in support of the use of Parsortix in the detection and assessment of prostate cancer more

Definiens Launches Immunoprofiling Panel to Rapidly Screen Tissue Samples for Immune Responses
| MUNICH, GERMANY - Mar 8, 2016 - Definiens, the pioneer in Tissue Phenomics solutions for diagnostics development and commercialization, today announced the release of a new service, the Immunoprofiling Panel, to enable pharmaceutical companies, companion diagnostic developers and academic research centers working in immuno-oncology to quickly screen their target biomarkers and measure immune response more

IMMray™ PanCan-d detects 98% of pancreatic cancers in retrospective study with 1400 blood samples
| LUND, SWEDEN - Dec 4, 2015 -     LUND, Sweden  ― CREATE Health Translational Cancer Center, Lund, Sweden in collaboration with Immunovia today announced that they have completed a retrospective study demonstrating that the IMMray™ PanCan-d test is able to differentiate with 96% accuracy patients with  early resectable stages of pancreatic cancer, stage I and II, from the healthy controls more

Insight Pharma Reports Announces Biomanufacturing Capacity Strategies: Developing a Flexible, Scalable and lean Biomanufacturing system
| NEEDHAM, MA, UNITED STATES - Oct 14, 2015 - For more information:Dan MillerInsight Pharma Reportsdmiller@healthtech.com781-972-5492 FOR IMMEDIATE RELEASE Insight Pharma Reports Announces Biomanufacturing Capacity Strategies: Developing a Flexible, Scalable and lean Biomanufacturing system

Insight Pharma Reports’ The Human Microbiome Report
| NEEDHAM, MA, UNITED STATES - Jun 19, 2015 - Insight Pharma Reports' releases the report, The Human Microbiome: Biomedical Implications and Birth of a Market, which covers the evolution of microbiome research and its growth in the commercial market more

Insight Pharma Reports Releases Marketing to Life Scientists Study
| NEEDHAM, MA, UNITED STATES - Jun 19, 2015 - Insight Pharma Reports, a division of Cambridge Healthtech Institute, releases a new market study focusing on marketing to life scientists more

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