Advancing the Diagnosis of Vaginitis
Two FDA-approved molecular testing platforms are leading to better targeted treatments for this common infection.
Category: Womens Health
Womens Health
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Womens Health
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April 2019 Product Spotlight: Immunoassay Analyzers
April 2019's product spotlight includes immunoassay kits and analyzers from companies such as Fujirebio, Ansh Labs, Tosoh Bioscience, and more.
Womens Health
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Sexually Transmitted Infections Present Diagnostic Challenges
The lack of symptoms and antibiotic resistance are big hurdles.
LGC Maine Standards Adds Cerebrospinal Fluid Total Protein to Validate Body Fluids Kit
The addition allows for easier validation of laboratory-developed tests, documentation of linearity and calibration verification, and verification of reportable range.
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Automating the Clinical Lab
The current generation of instruments for in vitro diagnostics is helping to support clinical labs through a strong emphasis on automation.
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New Test Enables Resistance-Guided Therapy for Gonorrhea
The ResistancePlus GC molecular diagnostic simultaneously diagnoses N. gonorrhoeae and provides antimicrobial susceptibility information, overcoming many of the issues associated with culture-based methods.
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FDA Permits Marketing of First Test to Aid in the Diagnosis of Mycoplasma genitalium Infection
Hologic’s first-in-category assay, cleared through FDA’s De Novo review process, provides laboratories with a highly sensitive and specific molecular diagnostic method to identify M. genitalium infections and enable effective treatment.
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Validate CM2 Kit for Ortho Vitros Analyzers
The kit assists laboratories in documenting their linearity and calibration verification for hs-CRP, NT-proBNP, and TnI assays.
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Parsortix Harvests Fetal Cells from the Blood of Pregnant Women
The Parsortix system offers the potential to extend NIPT to a wide range of conditions not feasible with existing techniques.
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FDA Clears MenoCheck as an Aid in the Determination of Menopausal Status
The MenoCheck assay was developed to aid physicians in determining the status of women during menopausal transition.
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DiaSorin Molecular Attains CE Mark for Simplexa Group B Strep Direct Molecular Assay
Designed for use on the company’s Liaison MDx instrument, the highly sensitive assay enables the direct in vitro detection of Group B Streptococcus DNA.
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BD Launches Molecular Test for Tuberculosis
The BD Max MDR-TB panel has obtained the CE mark, supporting market launch in Europe.
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Validate hsTnT Kit for Linearity and Calibration on Roche Cobas Analyzers
Validate hsTnT for Roche Cobas is the only linearity and calibration verification product specifically targeting Roche’s Troponin T Gen 5 Stat (TnTG5) assay.
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Healthcare Organizations Launch Unprecedented Effort to Improve Diagnosis
Every 9 minutes, someone in a US hospital dies due to a medical diagnosis that was wrong or delayed.
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Validate Heparin Linearity and Calibration Kit for Siemens Sysmex Analyzers
Validate heparin for Siemens Sysmex analyzers addresses laboratories’ need for a product to document heparin anti-Xa test linearity and calibration verification.
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Study Validates Biomarker for Aneuploidy and Adverse Pregnancy Outcomes
Statisticians used data from more than a million Panorama tests to devise an algorithm that computes a fetal fraction-based risk score for pregnancy.
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Spectrum Preimplantation Genetic Testing for Aneuploidy Improves IVF Outcomes
Natera’s genetic test evaluates the number of chromosomes in embryos to detect extra or missing chromosomes, and screens for inherited genetic disorders.
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August/September Product News
This month’s Product News section features products from Qiagen, ELITechGroup Biomedical Systems, and DiaSorin Molecular.
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