GeneDx Holdings Corp reported strong Q4 2025 earnings, driven by the INFINITY dataset with over 1 million exomes and genomes. The company is targeting mainstream medicine, focusing on pediatricians to address rare diseases. Growth is supported by a ‘stacking effect’. FDA Breakthrough Device Designation is a key differentiator. Expansion into international markets is underway.

The company expects 33%-35% volume growth in 2026, with 100 new sales reps added. A ‘one-minute ordering’ workflow for pediatricians will launch mid-year. Financial modeling anticipates Q1 as the annual low point. Gross margin targets 70%, prioritizing market capture over margin optimization. The hereditary cancer testing business was fully wound down in Q3 2025.

The company’s strategy includes converting single-gene panels to exome/genome tests. Management plans to optimize genome costs. The INFINITY reference dataset provides a competitive advantage. Long-read sequencing is being evaluated. A peer-to-peer model led by a neonatologist aims to standardize genomic protocols and assist pharma with clinical trials.

GeneDx Holdings Corp is confident in its growth strategy, focusing on market capture and accuracy. The company is expanding sales force to target broader indications, moving away from epilepsy and autism. The company’s test is twice as accurate as competitors. Pharma benefits from higher disease prevalence data, impacting rare disease therapies.

Read more at Yahoo Finance: GeneDx Holdings Corp. Q4 2025 Earnings Call Summary