GeneDx Granted FDA Breakthrough Device Designation for its ExomeDx™ and GenomeDx™ Testing
GeneDx Holdings Corp. - Class A (WGS)
Company Research
Source: Business Wire
Designation highlights GeneDx innovation in clinical whole genome and whole exome testing and accelerates the pathway for FDA authorization of these novel diagnostic tests GAITHERSBURG, Md.--(BUSINESS WIRE)--GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its whole genome and exome tests associated with causes of life-threatening diseases or genetic disorders to aid in diagnosis of symptomatic patients.With more than 2.5 million genetic tests performed in its CLIA certified, CAP accredited clinical laboratory, GeneDx continues to advance clinical genomic testing for rare diseases. The GeneDx ExomeDx covers the protein-coding regions, where most disease-causing variants occur, while GenomeDx sequences the entire genome to detect structural and non-coding variants often missed by other genetic testing methods like targeted pa
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News
- HALPER SADEH LLC ENCOURAGES GENEDX HOLDINGS CORP. SHAREHOLDERS TO CONTACT THE FIRM TO DISCUSS THEIR RIGHTSPR Newswire
- GeneDx to Showcase Advancements in Gene-Disease Discovery, Long-Read Sequencing and More at National Society of Genetic Counselors (NSGC) 2025 Annual MeetingBusiness Wire
- Artificial Intelligence Powered Rare Disease Diagnosis Research Report 2025: Market to Surpass $5.5 Billion by 2029 on Accelerated Adoption of Predictive and Personalized Healthcare - Forecast to 2034 [Yahoo! Finance]Yahoo! Finance
- GeneDx (NASDAQ:WGS) had its price target raised by analysts at Wells Fargo & Company from $95.00 to $140.00. They now have an "equal weight" rating on the stock.MarketBeat
- GeneDx to Participate in Upcoming Investor ConferencesBusiness Wire
WGS
Earnings
- 10/28/25 - Beat
WGS
Sec Filings
- 12/3/25 - Form 4
- 11/26/25 - Form 4
- 11/24/25 - Form 144
- WGS's page on the SEC website