Cytogenetics Platform Poised to Pursue FDA 510(k) Clearance SANTA CLARA, Calif.–Agilent Technologies Inc. (NYSE:A) today announced that its entire portfolio of DNA microarrays is now manufactured under ISO 13485 certification, an internationally recognized standard for quality management systems (QMS). “Agilent has always emphasized quality in the manufacture of microarrays, and we’re very pleased to be […]
7500 Fast Dx Real-Time PCR Instrument Meets European Requirements for In Vitro Diagnostic Use CARLSBAD, Calif.–Life Technologies Corporation (NASDAQ: LIFE) today announced that its Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument is available as a platform suitable for in vitro diagnostics (IVD) use in Europe. Clinical laboratories from 22 countries and European institutions that […]
New Service to Provide Breast Cancer Molecular Subtyping HUNTINGTON BEACH, California and AMSTERDAM — Agendia, a world leader in molecular cancer diagnostics, today announced that its breast cancer product offering, consisting of breast cancer recurrence test MammaPrint(R), and TargetPrint(TM), has been expanded with BluePrint (TM) to report important additional information on tumor subtypes. This new […]
CINCINNATI–Meridian Bioscience, Inc. announced today that it has submitted a 510(k) application to the United States Food and Drug Administration for marketing clearance of its new, simple molecular diagnostic test, illumigene™ C. difficile. illumigene is a simplified new technology platform, based upon loop amplification (LAMP) that makes molecular diagnostic testing possible for any size laboratory. […]
Top Contract Research Organization Is Retained to Expedite Submission and Approval of the Company’s Pre-Symptomatic Ovarian Cancer Screening Test SUNNYVALE, CA–Arrayit Corporation (OTC.BB:ARYC – News), a leader in life sciences, healthcare and molecular diagnostics, announced today that the company has appointed DOCRO, Inc. of Seymour, Connecticut, to assist in obtaining FDA approval for OvaDx. DOCRO […]
The Promega Maxwell® 16 IVD System is CE marked in accordance with the requirements of Directive 98/79/EC on in vitro diagnostic medical devices. The CE mark applies to the instrument, the Maxwell® 16 Blood DNA Purification System and the Maxwell® 16 Viral Total Nucleic Acid Purification System. The bench top automation system is fully compliant […]
Launch over 30 New Kits for Nucleic Acid-Based Diagnostics THOROLD, ON — Norgen Biotek Corp., an innovative privately held Canadian biotechnology company focusing primarily on advancing powerful tools for nucleic acids (NA) and protein purification, today announced the launch of over 30 new kits for nucleic-acid based diagnostics. Norgen makes best-in-class kits for nucleic acid […]
Partnership for Diagnostics and Genomics Services Utilizing the RDT 1000 for Sequence Enrichment and Targeted Resequencing Validation SAN DIEGO — Ambry Genetics and RainDance Technologies today jointly announced at the Annual CHI Next Generation Sequencing Conference in San Diego, CA their partnership utilizing the RDT 1000 for sequence enrichment and resequencing validation. A global leader […]
Powerful New Platform for New Molecular Diagnostic Tests ROCKVILLE, MD and SEOUL, KOREA — Seegene, Inc., a leader in multi-pathogen diagnostic testing, today unveiled a break-through technology called READ (Seegene Real Amplicon Detection) that marks a significant departure with current polymerase chain reaction (PCR) techniques that will enable an entirely new class of powerful molecular […]
Enzo’s Third Molecular Diagnostics Agreement Provides Access to Multiplex Sequencing Technology NEW YORK–Enzo Biochem, Inc. (NYSE:ENZ – News) today announced that it has entered into an agreement with MultiGEN Diagnostics Inc., of San Diego, California, for exclusive rights to market MultiGEN’s unique diagnostic tests based on multiplex DNA sequencing, in the state of New York. […]
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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.
