Genetic Cancer Test Granted FDA Breakthrough Device Designation
The designation’s accelerated regulatory review is intended to expedite use of the diagnostic in pharmaceutical trials.
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Search Results for: genetic testing
FDA Grants Breakthrough Device Designation to Companion Diagnostic
A companion diagnostic from Caris Life Sciences is the first test to detect gene fusions across all solid tumors.
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FDA Clears FluChip-8G Influenza A+B Assay
The multiplexed assay can positively characterize and differentiate a wide variety of influenza A virus strains as seasonal or nonseasonal, with same-day results.
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Analytics Platform Aims to Make Clinical Genomics Affordable
Partnering universities and companies in Europe and the United States have developed a hybrid Cloud-based platform for fast and cost-efficient whole-genome sequencing and analysis.
Read MoreMedneon Launches Predictive Genetics Breast Cancer Registry
The iGAP registry will capture information regarding breast cancer risk assessment, genetic testing utilization, and the impact of genetic information on treatment practices and patient outcomes.
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