GeneDx Holdings Corp. reports developments in genomic testing for rare disease diagnosis, with recurring updates on ExomeDx™ and GenomeDx™ testing, exome and genome test volumes, revenue growth, and full-year outlooks. The company uses GeneDx Infinity™, a rare disease genomic dataset, to support clinical interpretation, AI-enabled variant analysis, and biopharma discovery.
Company news also covers research publications and medical-meeting abstracts, health economics studies involving whole exome and whole genome sequencing, sponsored genetic testing programs for suspected rare diseases, and partnerships intended to expand access to genomic diagnosis. Updates frequently connect clinical data, sequencing technology, and rare disease patient identification with the company's precision-medicine operating model.
GeneDx (Nasdaq: WGS) announced GenomeDx Prenatal, a phenotype-informed, trio whole genome sequencing test for pregnancies with fetal anomalies, available to order in February 2026. The test builds on >10 years of prenatal experience and >4,000 prenatal exomes, uses the GeneDx Infinity rare-disease dataset, and targets broad variant detection across key prenatal indications with results in less than two weeks. GenomeDx Prenatal is positioned to inform time-sensitive counseling, delivery planning, and postnatal care through comprehensive detection, free postnatal reanalysis, and optional lifetime reanalysis.
GeneDx (Nasdaq: WGS) appointed Dr. Linda Genen, MD, MPH as Chief Medical Officer on January 6, 2026 to lead Medical and Clinical Affairs and drive clinical strategy for earlier diagnosis and broader adoption of genomic medicine.
Dr. Genen joins from ProgenyHealth and has prior leadership at UnitedHealth Group, Optum, and clinical experience as a neonatologist and assistant professor. She will guide payer engagement, real-world evidence initiatives, and cross‑functional innovation to expand exome and genome testing in routine care.
GeneDx (Nasdaq: WGS) reported a record 2025 for medical affairs and research, publishing 79 peer-reviewed studies and reaching a cumulative total of over 1,100 studies. GeneDx says its GeneDx Infinity dataset includes nearly 1 million exomes and genomes with deep phenotypes and 25+ years of clinical experience. 2025 highlights include four practice‑shaping publications, 56 GeneMatcher-enabled discoveries, 38 conference abstracts, and the GUARDIAN newborn-screening study selected for JAMA’s Research of the Year Roundup. Reported outcomes: partnerships with 175 clinicians at 74 institutions, diagnoses for 136 patients, and 31 newly clinically validated gene–disease associations in 2025.
GeneDx (Nasdaq: WGS) announced that management will participate in the 44th Annual J.P. Morgan Healthcare Conference in San Francisco from January 12–15, 2026. Katherine Stueland, President and CEO, will present on Wednesday, January 14, 2026 at 3:00 p.m. PT. Live and archived webcasts will be available in the company’s Events section on the investor relations website.
GeneDx (Nasdaq: WGS) announced the GUARDIAN newborn genomic screening study was named to JAMA’s Research of the Year roundup on December 15, 2025. The peer-reviewed analysis of the first 4,000 enrolled newborns reported a 72% parental consent rate, a 3.7% screen-positive rate, and that 92% of screen-positive newborns had a confirmed diagnosis for a condition not included in traditional newborn screening.
The study has screened more than 20,000 newborns to date with a goal of 100,000, and identifies actionable conditions (eg, long QT syndrome, Wilson disease, SCID) where earlier diagnosis enables timely intervention.
GeneDx (Nasdaq: WGS) will present research at the NSGC 2025 Annual Meeting (Nov 7–9, 2025) highlighting gene-disease discovery, long-read sequencing, and access/reimbursement work.
Key points: GeneDx promotes its GeneDx Infinity rare-disease dataset and cites >1,000 scientific publications. The company reports curation of >9,000 gene-disease associations and will present data showing HiFi long-read sequencing detected nearly all technically challenging variants and enabled phasing in singleton clinical samples.
GeneDx (Nasdaq: WGS) announced management will participate in three investor conferences in November–December 2025: a Stifel fireside chat on Nov 12, 2025 at 2:00 p.m. ET; a Jefferies presentation on Nov 19, 2025 at 11:00 a.m. GMT; and a Piper Sandler fireside chat on Dec 3, 2025 at 1:30 p.m. ET.
Live and archived webcasts will be available in the Events section of the GeneDx investor relations website at ir.genedx.com/news-events/events.
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.