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..

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..

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. ..

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..

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..

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..

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 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 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 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 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..

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. ..

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..

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..

A New Frontier in Molecular Diagnostics?(By Melanie Yarbrough, PhD) The discovery that noncoding regions of the genome such as microRNAs(miRNAs)can influence the pathogenesis of cancer has led investigators to con..