YEARS LOST: QUANTIFYING THE HUMAN COST OF DELAYED GENETIC DIAGNOSIS

Author(s)

Colton E. Frazer, PharmD, MBA1, E. Gay Grossman, BA1, Jackie Cruickshank, MS1, Sarah Soto, MS1, Krystal Brown, PhD1, Elli Brimble, MS2, Steph Eanff, MS2, Britt Johnson, PhD1;
1GeneDx, Stamford, CT, USA, 2Citizen Health, San Francisco, CA, USA
OBJECTIVES: Describe the humanistic burden of diagnostic odysseys (DO) on patients and their families.
METHODS: This is a convergent mixed-methods study that integrated qualitative interviews with electronic medical records (EMR). GeneDx interviewed parents of children with neurodevelopmental disorders (N=2) who received a genetic diagnosis using GeneDx exome sequencing (ES) following prolonged DOs. Interviews underwent inductive thematic analysis. Citizen Health abstracted EMRs from birth to present, quantifying healthcare resource utilization (HCRU) pre- and post-ES.
RESULTS: DO durations were 4.5 and 8 years, averaging 4 emergency visits, 9 clinic visits, and 10 diagnostic tests per patient annually before ES. Families described frustration with repeated uninformative tests, long waits between referrals, and extensive travel disrupting daily life and employment. One northwest US family traveled an estimated 9,400 miles (over 150 driving hours) for out of state specialists over their 8-year DO. Time from symptom onset (beginning of DO) to first non-ES genetic test ranged from 10 days to 3.5 years; first-tier GeneDx ES could have avoided 4.5 years of diagnostic delay per patient. ES results significantly impacted clinical management, tailoring treatments and identifying contraindicated medications. Post genetic diagnosis, patients experienced meaningful annual HCRU reductions of 85% and 77%, and gained community belonging through patient advocacy organizations. Despite clinical improvements, parents reported persistent negative impacts on family well-being and career, including mental health crises, social withdrawal, and inability to rejoin the workforce. Four key themes emerged: (1) fragmented, resource intensive diagnostic work-ups (2) barriers preventing earlier ES access, creating avoidable delays (3) clarity following ES diagnosis and (4) persistent family-level impacts.
CONCLUSIONS: Delayed diagnosis imposed substantial, avoidable burdens to two families. Policymakers and health systems should prioritize expediting diagnostic pathways for individuals with suspected genetic disorders, enabling families to focus on treatment rather than diagnosis and mitigating preventable stressors.

Conference/Value in Health Info

2026-05, ISPOR 2026, Philadelphia, PA, USA

Value in Health, Volume 29, Issue S6

Code

PCR62

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

SDC: Pediatrics, SDC: Rare & Orphan Diseases

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