GeneDx Holdings (WGS) Stock News

GeneDx (Nasdaq: WGS) reported third quarter 2025 results with $116.7M revenue and year-over-year exome/genome revenue growth of 65%. Exome/genome volume rose to 25,702 (+33% YoY) and represented 43% of all tests. Adjusted gross margin expanded to 74% (from 64%), and adjusted net income was $14.7M versus $2.0M a year earlier. GAAP net loss was $7.6M. Cash and equivalents totaled $156.1M; free cash flow for the quarter was $8.8M. Management raised 2025 revenue guidance to $425–$428M and increased expected exome/genome revenue growth to 53%–55%. The company received FDA Breakthrough Device Designation for ExomeDx and GenomeDx and highlighted expanded genomic newborn screening participation.

GeneDx (Nasdaq: WGS) presented data and multiple talks at ICoNS 2025 highlighting its role in bringing genomic newborn screening (gNBS) into clinical practice.

Key facts: GeneDx serves as lab partner for major U.S. gNBS programs (GUARDIAN, Early Check pilot, BEACONS, Florida Sunshine Genetics) with ~22,000 newborns screened to date; it acquired Fabric Genomics earlier in 2025 and operates on GeneDx Infinity™, backed by nearly 1 million sequenced exomes/genomes and >7 million phenotypic datapoints.

GeneDx (Nasdaq: WGS) announced that on October 20, 2025 the U.S. Food and Drug Administration granted Breakthrough Device Designation for its ExomeDx (whole exome) and GenomeDx (whole genome) tests for diagnosing symptomatic patients with life‑threatening or genetic disorders.

The designation offers an expedited FDA review pathway and closer agency collaboration. GeneDx said its tests are powered by GeneDx Infinity — nearly 1 million sequenced exomes/genomes and over 7 million phenotypic datapoints — and aim to detect coding, structural, and noncoding variants often missed by panels or microarray.

Illumina (NASDAQ: ILMN) said GeneDx piloted its emerging constellation mapped read technology on 160 DNA samples and reported improved detection of hard-to-map variants versus orthogonal methods. The pilot identified repeat expansions (DMPK), SMN1 events, NCF1-related variants, complex structural variants, and mosaic aneuploidy across blood, buccal, and prenatal samples.

Constellation uses on-flow-cell long molecules with proprietary informatics to resolve homologous and repetitive regions. A commercial product is planned for H1 2026. GeneDx results were presented at ASHG on Oct 15, 2025.

GeneDx (NASDAQ: WGS) announced on October 14, 2025 that Dr. Mimi Lee, MD, PhD, will join as Chief Precision Medicine Officer to lead the company’s strategy to integrate genomics across the lifespan.

Dr. Lee will advance precision medicine adoption by partnering with policymakers, health systems, biopharma, payers, and advocacy groups, and promote sequencing earlier in life to enable prediction, prevention, and optimized care. She joins from ARPA-H and has senior leadership experience at Samsung Bioepis, Novartis Institutes of Biomedical Research, and BioMarin.

GeneDx (Nasdaq: WGS) will partner with Florida State University and the Florida Institute for Pediatric Rare Diseases to support the Sunshine Genetics Act, a five-year pilot state-backed genomic newborn screening (gNBS) program effective July 1, 2025.

The program aims to offer free, voluntary whole-genome sequencing to newborns at select academic medical centers and hospitals, with a goal to sequence 100,000 newborns. GeneDx will provide end-to-end genomic testing, sequencing, expert interpretation, and clinical reporting, leveraging its record of sequencing nearly 1 million exomes and genomes and prior GUARDIAN-study experience sequencing >17,000 newborns where genome sequencing identified rare disease in 3.2% of cases.

GeneDx (Nasdaq: WGS) launched an Autism Partnership Program on October 9, 2025 to expand access to exome and genome testing, including a dedicated SHANK3 program for Phelan-McDermid syndrome. Jaguar Gene Therapy is the founding partner and will cover testing costs when patients have Medicare/Medicare Advantage and commercial coverage is unavailable. The program targets individuals in the US with moderate-to-severe developmental delay, intellectual disability, ASD, or autistic-like behavior with clinical suspicion of Phelan-McDermid syndrome.

Genetic data from the program will support research and therapy development; cited prevalence estimates include ~0.5%–0.69% of ASD patients with SHANK3 variants (~46,000 US patients).

GeneDx (Nasdaq: WGS) will present research at the American Society of Human Genetics Annual Meeting on October 15–16, 2025 highlighting results enabled by GeneDx Infinity, a dataset of nearly 1 million exomes/genomes and over 7 million phenotypic datapoints. GeneDx will showcase 14 studies across genomic newborn screening, neurodevelopmental disorders, diagnostic technologies, long‑read sequencing validation, and machine learning applications.

Key disclosed results include a study of >62,000 individuals with autism identifying core genes and genetic correlations with other disorders, GUARDIAN gNBS data from 15,000 newborns with high enrollment and follow‑up outcomes, and benchmarking that shows high concordance of CNV detection between exome/genome sequencing and chromosomal microarray.

GeneDx (NASDAQ: WGS) will report Q3 2025 financial results before the market opens on Tuesday, October 28, 2025. Management will host a conference call at 8:30 a.m. Eastern Time the same day to discuss financial and operating results. Investors must register online to access the call. A live and archived webcast will be available in the Events section of the GeneDx investor relations website at https://ir.genedx.com/. The announcement provides timing, registration requirement, and webcast access details for shareholders and analysts.