GeneDx
Rare disease genomic diagnosis (NASDAQ: WGS), applying AI and expert variant interpretation to exome and genome sequencing. GeneDx Infinity is the company's rare disease genomic dataset, accumulated over roughly 25 years and described by the company as the largest and most comprehensive of its kind. Products span ExomeDx and GenomeDx, both granted FDA Breakthrough Device designation, ultraRapid genome sequencing returning results for NICU and PICU patients in as little as 48 hours, and GenomeDx Prenatal, a phenotype informed trio based whole genome test for pregnancies with fetal anomalies. The company is the sole commercial testing provider for the NIH BEACONS genomic newborn screening initiative, which aims to enroll up to 30,000 newborns across as many as ten states. Reimbursement position is unusually well documented: Medicaid coverage for exome or genome sequencing in the pediatric outpatient setting across 38 states and for rapid genome sequencing in the NICU across 17. Full year 2025 revenue of $427.5 million with 2026 guidance of $475 to $490 million.
Capability Axes
AI performs variant interpretation and classification over the GeneDx Infinity dataset, which is where diagnostic yield in rare disease actually comes from: the same sequencing data interpreted against a larger reference of prior cases produces more answers. Held back from A for the reason applied consistently to GRAIL, Freenome, and Caris: the product is a sequencing assay plus an interpretive layer, and the wet lab remains load bearing. The dataset, rather than the model, is the durable asset here.
Among the deepest evidence positions in the index, and it is external rather than self reported. Peer reviewed publications include a benchmarking study in the American Journal of Human Genetics and SeqFirst data in the American Journal of Medical Genetics showing rapid genome sequencing as a first tier test in pediatric and cardiac intensive care significantly increases diagnostic rates and halves time to diagnosis. The American Academy of Pediatrics updated guidance in June 2025 to recommend exome and genome sequencing as first tier tests for children with global developmental delay or intellectual disability, which is guideline level validation of the modality. Graded on the existence and venue of the evidence; this index does not re verify the underlying studies.
ExomeDx and GenomeDx hold FDA Breakthrough Device designation, and the company consistently describes it as designation rather than clearance or approval, which is the correct distinction and one that is frequently blurred elsewhere. Held back from A because the current regulatory pathway for the tests as marketed, and the timeline for any submission, were not disclosed in the retrieved materials.
Test prices are not published, but the commercially decisive information for a health system is, in unusual detail: Medicaid coverage for exome or genome sequencing in the pediatric outpatient setting across 38 states, and for rapid genome sequencing in the NICU across 17. For a reimbursement funded diagnostic, coverage breadth by state determines whether the test is orderable for a given patient far more than list price does. That disclosure is more useful than a rate card would be.
Clearly bounded and specifically enumerated across the care continuum: rare disease diagnosis in pediatric outpatient settings, NICU and PICU via ultraRapid sequencing, prenatal via GenomeDx Prenatal, and newborn screening through the BEACONS initiative. Each product states its intended population rather than claiming general applicability.
Pricing
Vendor-published figures are labeled as such. Figures labeled “Estimated” are derived from third-party sources and have not been confirmed by the vendor.
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Per test through payer reimbursement; coverage varies by state and setting | — | — | Vendor Published |
Test prices are not published; the tests are reimbursement funded. The operative commercial information is coverage rather than price, and the company discloses it in detail: Medicaid coverage for exome or genome sequencing in the pediatric outpatient setting across 38 states, and for rapid genome sequencing in the NICU across 17. A health system should confirm coverage in its own state and payer mix before assuming orderability.