BD Rx Inc., a wholly-owned subsidiary of leading global medical technology company BD (Becton, Dickinson and Company) (NYSE:BDX), announced today that the U.S. Food and Drug Administration (FDA) has approved the third drug to be offered in the new BD Simplist™ line of ready-to-administer prefilled generic injectables. The third BD Simplist product to launch is […]
SUNNYVALE, Calif.,– Cepheid (NASDAQ: CPHD) today announced the U.S. Food & Drug Administration (FDA) has categorized Cepheid’s Xpert®MTB/RIF test as ‘Moderate Complexity’ under the Clinical Laboratory Improvement Amendments (CLIA). Xpert MTB/RIF is designed for the rapid molecular detection ofMycobacterium tuberculosis complex (MTB-complex) DNA and, in specimens where MTB-complex DNA is detected, Xpert MTB/RIF also detects […]
Spartan Bioscience today announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance permitting marketing of the Spartan RX CYP2C19 System. It provides genetic results in less than 60 minutes from a non-invasive cheek swab. The automated system is indicated as an aid for clinicians to determine therapeutic strategy for drugs metabolized by […]
Baltimore, MD – BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today the U.S. Food and Drug Administration clearance and launch of the BD ProbeTec™ Trichomonas vaginalis Qx Amplified DNA Assay for the direct qualitative detection of T. vaginalis DNA in endocervical and vaginal […]
Franklin Lakes, NJ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, supports the U.S. Food and Drug Administration’s (FDA’s) proposed reclassification of rapid influenza detection tests. A hearing, held on June 13th by FDA’s CDRH Microbiology Devices Advisory Committee Meeting, examined the FDA’s proposal to reclassify rapid influenza detection […]
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the worldwide commercial availability of the Tina-quant HbA1cDx Gen.2 laboratory test, which aids healthcare professionals in diagnosing and monitoring diabetes in addition to identifying at-risk patients. Thanks to this new test, which will be commercially available in the third quarter of 2013 as part of the COBAS […]
BOSTON, MA – Partners HealthCare today announced that it has started offering doctors and patients the option of whole genome sequencing, analysis and interpretation. The test, available to patients across the nation, will offer physicians and patients the ability to better diagnose and treat disease. Partners is the one of the first health care systems […]
Emory Genetics Laboratory, through a partnership with Verinata Health, an Illumina company, will begin providing the verifi® prenatal test for patients desiring non-invasive prenatal testing. All pregnant women within the Emory Genetics Laboratory network determined to be high-risk by their physicians will be offered the option of the verifi prenatal test. The verifi prenatal test […]
Melbourne, Australia,: Agenix Limited (ASX: AGX) is pleased to announce that it has entered into a co-operation and cross-licensing agreement with Scotland based Arrayjet Limited, a specialist with existing expertise and intellectual property in microarray technology. The agreement commits the partners to undertake R & D both in Scotland and Australia to jointly develop a […]
Temecula, Calif. – Golden West Biologicals, Inc.® (GWB) a leading U.S.-based provider and manufacturer of diagnostic products, today announced the appointment of a new distributor for Korea. The company anticipates adding several more worldwide distributors in the coming months. “With more than 700 customers worldwide, we see a tremendous opportunity for growth of our Mass […]
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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.

