newborn screening
GeneDx Stock Soars as Firm Reports 44 Percent Revenue Growth, $1.2M Adjusted Net Income in Q3
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Revenues in the third quarter were driven by diagnostic exome and genome tests, which grew 76 percent in revenue and 46 percent in volume, prompting the firm to raise its 2024 guidance.
Yourgene Health Cystic Fibrosis Assay Receives IVDR Certification
The assay uses amplification-refractory mutation system (ARMS) technology and genetic analyzers to detect the 50 most common CF mutations in European ancestry populations.
FDA Draft Guidances Detail Plans for Enforcement Discretion During Public Health Emergencies
The guidances, which are open for comment through July 5, lay out agency thinking on the regulation of lab-developed tests in emergency situations following its May 6 final rule.
The research study, run by Genomics England in collaboration with the UK's National Health Service, plans to sequence the genomes of 100,000 newborns.
Revvity to Provide Genome Sequencing for North Carolina Newborn Screening Study Under Deal With RTI
Starting in May, Revvity will sequence the genomes of infants that are part of RTI International's Early Check study to identify rare childhood-onset genetic conditions.