San Jose, Calif.,– Ariosa Diagnostics, maker of the non-invasive Harmony™ Prenatal Test for risk assessment of common genetic conditions, has announced the expansion of the Harmony Prenatal Test to include the option of Y-chromosome analysis, which can provide information on fetal sex and aneuploidy as early as 10 weeks gestation. The new “Harmony with Y […]
CINCINNATI — Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) today announced the U.S. Food & Drug Administration (FDA) has re-categorized Meridian’s illumigene® Group A Streptococcus and illumigene® Group B Streptococcus tests as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments (CLIA). Moderately complex tests are assays that are considered to be simple and easy to […]
SAN DIEGO and CARLSBAD, Calif., — Quidel Corporation (NASDAQ: QDEL) and Life Technologies Corporation (NASDAQ: LIFE) announced today that they received 510(k) clearances from the United States Food and Drug Administration (FDA) to market the Quidel Molecular Direct C. difficile Assay with Life Technologies’ QuantStudio ™ Dx and 7500 Fast Dx Applied Biosystems® Real-Time PCR […]
WHITEHOUSE STATION, N.J. & AUSTIN, Texas — Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Luminex Corporation (NASDAQ:LMNX) have signed a collaboration and license agreement to develop a companion diagnostic device that will be evaluated to help screen patients for recruitment into Merck’s clinical development program for MK-8931, a novel […]
Franklin Lakes, NJ – BD (Becton, Dickinson and Company) (NYSE:BDX), a leading global medical technology company, today announced the appointment of Ellen Strahlman, M.D., M.H.Sc., to the newly created position of Chief Medical Officer and Senior Vice President, Research & Development, effective April 22, 2013. Dr. Strahlman will report to Chairman, CEO and President Vincent […]
SAN ANTONIO, Texas — Aspect Imaging, the world leading developer of high-performance compact magnets, today announced the launch of its M2™ 3D MR-based histology system for in vivo and ex vivo toxicological imaging. The announcement was made at the 52nd Society of Toxicology Annual Meeting in San Antonio, Texas, March 10 -14, 2013, the largest […]
Männedorf, Switzerland – The Tecan Group (SIX Swiss Exchange: TECN) announced today that its OEM partner Dako, an Agilent Technologies Company and worldwide provider of cancer diagnostics, unveiled the new advanced staining platform at the 2013 USCAP congress in Baltimore, Maryland, USA. Earlier this week, it was presented to a global gathering of pathologists and […]
SEATTLE and BALTIMORE, Md. – NanoString Technologies, Inc., a privately held provider of life science tools for translational research and molecular diagnostic products, today announced that results presented at the 2013 United States & Canadian Academy of Pathology annual meeting validate the analytical reproducibility of the company’s Prosigna™ Breast Cancer Prognostic Gene Signature Assay. Prosigna, […]
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received approval from the US Food and Drug Administration (FDA) for a next-generation viral load test to be used in the management of patients with chronic hepatitis C virus (HCV) infection. The COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 provides a novel dual-probe approach, for […]
Vista, CA — Leica Biosystems, which through its acquisition of Aperio became the leading provider of digital pathology systems, announced today that Chinese physicians have access to U.S. healthcare organizations for real-time, expert review of pathology cases through the first scalable, secure medical cloud network through its strategic collaboration with Dell Healthcare and Life Sciences. […]
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IBO (Instrument Business Outlook) is a twice-monthly newsletter aimed at providing decision-makers with the latest and most complete information available on the life science and analytical instrument industry, and lab product markets. IBO delivers the latest curated industry news, information and trends, as well as SDi data and analysis to deliver the maximum in industry insight with a minimum time investment for executives and investors.
