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In Vitro Diagnostics News

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Akers Biosciences signs three-year agreement with GNYHA Services for heparin PF4 rapid test
Akers Biosciences, a developer of rapid health information technologies, reported that it has signed a three-year agreement with the Greater New York Hospital Association (GNYHA) to introduce the company's flagship rapid tests for heparin-induced thrombocytopenia across GNYHA's network of over 300 member hospitals and health systems.
Diagnostics > In Vitro Diagnostics > News
GenMark seeks FDA approval for ePlex respiratory pathogen panel
By MDBR Staff Writer
GenMark Diagnostics is seeking approval from the US Food and Drug Administration (FDA) for its ePlex sample-to-answer instrument and respiratory pathogen panel.
Diagnostics > In Vitro Diagnostics > News
Exosome Diagnostics presents highest sensitivity liquid biopsy test for lung cancer
Exosome Diagnostics has presented data that sets a new standard for EGFR-T790M resistance mutation detection in lung cancer, with the highest sensitivity reported to date.
Diagnostics > In Vitro Diagnostics > News
Agilent, Rubicon sign supply agreement for PicoPLEX WGA kits
By MDBR Staff Writer
Rubicon Genomics has entered into a supply agreement with Agilent Technologies for its PicoPLEX WGA kits.
Diagnostics > In Vitro Diagnostics > News
Invitae expands pediatric, neurological, and rare disease genetic test offerings
By MDBR Staff Writer
US genetic information firm Invitae has expanded its pediatric, neurological, and rare disease genetic test offerings with new and extended panels.
Diagnostics > In Vitro Diagnostics > News
Bayer, Leica Biosystems to develop companion diagnostic tests for cancer patients
Bayer has entered into an agreement with Leica Biosystems to collaborate on the development of companion diagnostic tests based on tissue samples using RNAscope (a multiplex nucleic acid hybridization technology) and immunohistochemistry for cancer patients.
Diagnostics > In Vitro Diagnostics > News
Personal Genome Diagnostics launches CancerSELECT 125 test for pan-cancer tumor profiling
Personal Genome Diagnostics (PGDx), a provider of advanced cancer genome testing products and services, today announced the launch of its CancerSELECT 125 test for pan-cancer tumor profiling.
Diagnostics > In Vitro Diagnostics > News
Foundation Medicine receives FDA approval of FoundationFocus CDxBRCA as companion diagnostic for Rubraca
By MDBR Staff Writer
Foundation Medicine (FMI) announced that the US Food and Drug Administration (FDA) has approved FoundationFocus CDxBRCA for use as a companion diagnostic to aid in identifying women with ovarian cancer for whom treatment with Rubraca™ (rucaparib), a therapy developed by Clovis Oncology, is being considered.
Diagnostics > In Vitro Diagnostics > News
Clinical Genomics launches blood-based test for CRC recurrence monitoring
By MDBR Staff Writer
Clinical Genomics has introduced a new a blood-based test for colorectal cancer (CRC) recurrence monitoring.
Diagnostics > In Vitro Diagnostics > News
Cepheid gets FDA approval for next generation MRSA infection control test
By MDBR Staff Writer
Cepheid has secured approval from the US Food and Drug Administration (FDA) for its next generation methicillin-resistant Staphylococcus aureus (MRSA) infection control test, Xpert MRSA NxG.
Diagnostics > In Vitro Diagnostics > News
HiberGene gets CE mark approval for HG C. difficile test
By MDBR Staff Writer
Ireland-based HiberGene Diagnostics has secured CE mark approval for its HG C. difficile test.
Diagnostics > In Vitro Diagnostics > News
Med-IQ, MedStar Health partner to improve HCV testing and linkage to specialty care
The Med-IQ Quality Improvement Institute has joined forces with MedStar Health, the healthcare provider in Maryland and Washington, DC, to address the substantial burden of unrecognized chronic hepatitis C virus (HCV) infection among the baby boomer population.
Diagnostics > In Vitro Diagnostics > News
Oxford Gene Technology introduces three new Cytocell Aquarius FISH probes
Oxford Gene Technology (OGT) has expanded its Cytocell sarcoma fluorescence in situ hybridisation (FISH) probe range with three new products.
Diagnostics > In Vitro Diagnostics > News
PROTAGEN launches NavigAID assay to support clinical drug development for autoimmune diseases
PROTAGEN has launched NavigAID SSc, a disease stratification assay designed to support pharmaceutical and biotechnology companies with their Systemic Sclerosis (SSc) drug development efforts.
Diagnostics > In Vitro Diagnostics > News
Siemens Healthineers to invest $300m in US laboratory diagnostics manufacturing facility
By MDBR Staff Writer
Siemens Healthineers is investing $300m in Walpole, Massachusetts laboratory diagnostics manufacturing facility over the next four years.
Diagnostics > In Vitro Diagnostics > News
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