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Thermo Fisher to develop companion diagnostics for GSK and PFE
2014-10-08
Thermo Fisher Scientific (NYSE: TMO) enters into an agreement with GlaxoSmithKline (NYSE: GSK) and Pfizer (NYSE: PFE) to develop a universal next-generation sequencing (NGS) oncology test for solid tumors that will se..
Emergency Approval of Ebola Test Suggests Opportunity for Test Makers
2014-10-08
The emergency approval of a real-time PCR test for Zaire Ebolavirus demonstrates the scope of concern about the recent epidemic and a possible opportunity for test makers. The biennial study of the microbiology test p..
FDA Clears Rapid Blood Test for Sepsis-Causing Pathogens
2014-09-29
The US Food and Drug Administration (FDA) has cleared for marketing the first direct blood test capable of rapidly detecting 5 Candida species that cause bloodstream infections that often lead to sepsis. The T2Can..
First European Company Obtains CE-IVD Marking for Next Generation Sequencing in Routine Testing
2014-09-29
For the first time, a European company, Sophia Genetics (Lausanne Switzerland), has obtained the CE-IVD mark for clinical use of Next Generation Sequencing (NGS) bioinformatics pipeline for routine genetic testing. ..
Funding Awarded to Develop Diagnostic Point-of-Care Device for Sickle Cell Disease
2014-09-29
Rockland Immunochemicals, Inc. (Limerick, PA, USA) has announced the award of a USD 224,473 Small Business Innovation Research (SBIR) grant from the NIH National Heart Lung and Blood Institute (NHLBI) to develop an an..
Initiative Launched to Make Genetic Profiles a Routine Part of Clinical Decisions
2014-09-29
Laboratory Corporation of America Holdings (LabCorp; Burlington, NC, USA) has launched “Enlighten Health Genomics,” a new business that builds on the diagnostic potential of next-generation sequencing (NGS..
Most IVD Sector Companies Look Outside the EU and USA for Growth
2014-09-09
Kalorama Information (New York City, NY, USA) has now published the 9th edition of its biennial market research report “Worldwide Market for In Vitro Diagnostics,” revealing estimates from its survey of th..
Social Diagnostics Start-Up to Provide Simple, Affordable Tests Worldwide
2014-09-02
The Royal Tropical Institute (KIT; Amsterdam, Netherlands) is establishing a nonprofit, social diagnostics company that develops and markets tests for the diagnosis of poverty-related diseases. Infectious diseases..
Quidel receives FDA clearance for Hand-Held Molecular Diagnostic Test for Group A Strep
2014-09-02
Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing systems, announced that it has received clearance from the United States Food and Drug Administration (FDA) to market its AmpliVue GAS Assay fo..
Ventana Paves the Way for High-Standard Companion Diagnostic Clinical Trials Services in China
2014-08-22
Ventana Medical Systems, Inc. (Tucson, AZ, USA), member of the Roche Group, has announced a new agreement with Quintiles, Inc. (Durham, NC, USA) to offer College of American Pathology (CAP)-standard companion diagnost..
EKF Wins Distribution Contract and Regulatory Approval for Target Regions
2014-08-14
EKF Diagnostics Holdings (Cardiff, Wales, UK), an AIM-listed point-of-care, central laboratory and molecular diagnostics business, announced that it has signed a new distribution contract in China and that one of its ..
Atomo's Blood Test Unveiled at 2014 AACC; Takes Top Award in NY
2014-08-14
Atomo Diagnostics (Melbourne, Australia) showcased integrated rapid blood test device to the USA market at the 2014 AACC Annual Meeting and Clinical Lab Expo, following a successful presentation at the 20th Internatio..
Corgenix Diagnostic Ebola Test Research Earns Abstract Award
2014-08-14
The Best Annual Meeting Abstract Award is given by the AACC Critical and Point-of-Care Testing Division in recognition of outstanding research for abstracts submitted and posters presented at the AACC annual meeting. ..
The Wild West of Laboratory-Developed Tests
2014-08-13
By David Colantonio, PhD Most testing conducted in today’s clinical laboratories uses commercial reagent kits, manufactured and marketed by in vitro diagnostics companies. However, many new and existing biom..
CACLP attended the 2014 AACC Expo
2014-08-06
On March 29 – 31, 2014, China Association of Clinical Laboratory Practice(CACLP) attended the 2014 AACC Expo. During the expo, we have discussed with the foreign IVD companies who want to increase active in..
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