Tag: CE-IVD

Promega Intends to Seek FDA Approval for Microsatellite Instability Assay to Assist in Strategic Cancer Decisions

| July 9, 2017 | 0 Comments

Promega Corporation intends to seek FDA approval and CE-IVD marking for a commercially available Microsatellite Instability (MSI) assay to assist oncologists and pathologists in determining colorectal cancer decisions. The current Promega Research Use Only MSI Assay has been available and used in the market as part of Lab-Developed Tests since 2004 and is considered the […]

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HalioDx receives CLIA Compliance for Immunoscore® Colon

| June 21, 2017 | 0 Comments

HalioDx receives CLIA Compliance for its laboratory based in Marseille Immunoscore® Colon, is now available to US patients in selected states with a turnaround time of 10 days Marseille, June 21, 2017 – HalioDx announced today that the company is compliant under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for its Marseille-based full service […]

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Applied Spectral Imaging Announces Its GenASIs Applications Comply with CE-IVD Requirements with the IQFISH Lung Cancer Panel on Dako Omnis of Agilent Technologies Inc

| January 11, 2017 | 0 Comments

Carlsbad, CA – January 11, 2017 – Applied Spectral Imaging (ASI) announced today that its GenASIsTM  applications comply with CE-IVD requirements under the European Directive on In Vitro Diagnostic Medical Devices, for automated analysis with the IQFISH lung cancer panel on Dako Omnis (comprising of ALK, ROS1, RET and MET IQFISH probes) of Agilent Technologies […]

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Immunoscore® Colon is available as a CE-IVD solution

| January 5, 2017 | 0 Comments

Immunoscore® Colon is the first standardized immune‐based assay for the classification of cancers Immunoscore® has been validated by the Immunoscore® worldwide consortium, led by the SITC (ASCO 2016) Immunoscore® is a superior predictor of survival than microsatellite instability Marseille, France, January 5, 2017 – HalioDx SAS, an independent immuno-oncology diagnostic company, today announced that its […]

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