FDA Grants Breakthrough Device Designation for Whole Genome and Exome Tests
The designation accelerates regulatory review for GeneDx’s ExomeDx and GenomeDx testing platforms designed to diagnose rare diseases.
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Search Results for: GeneDX
US Genomic Newborn Screening Initiative Launches with $14.4 Million NIH Award
BEACONS, a multi-state collaboration led by Mass General Brigham and Ariadne Labs, will enroll up to 30,000 newborns to explore adding genomic sequencing in US newborn screening.
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GeneDx Names Partners for Epilepsy Diagnostic Program
GeneDx named the partners of its Patient Access Program that provides whole exome sequencing for pediatric epilepsy.
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How Systemic Barriers Cause Racial Disparities in Genetic Diagnosis
A study reveals that while diagnostic accuracy in genetic testing is consistent across racial groups, access disparities persist.
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How Genomic Sequencing Can Outperform Standard Newborn Screening Tests
Early results from a new study demonstrate that genomic sequencing identifies significantly more treatable health conditions in newborns.
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