Myriad Genetics closed 2025 with flat fourth-quarter revenue at $209.8 million, a 70% gross margin, and a modest GAAP net loss of $7.9 million while posting positive adjusted EPS and $14.3 million in adjusted EBITDA. Full-year revenue declined 2% to $824.5 million, but rose 2% excluding the impact of UnitedHealthcare’s discontinuation of GeneSight coverage and the prior divestiture of EndoPredict. The company reaffirmed 2026 guidance of $860–$880 million in revenue and $37–$49 million in adjusted EBITDA, and pinned launch timelines for three programs: an alpha release of Precise MRD in breast cancer in March, a full commercial launch of an AI-enabled Prolaris prostate cancer assay in partnership with PathomIQ in the second quarter, and the FirstGene multiple prenatal screen in the second half.

The strategic question is whether this pivot toward higher-value oncology and women’s health assets can outrun payer volatility and translate volume momentum into durable, reimbursed growth. GeneSight illustrates the tension: fourth-quarter test volume increased 9% year over year, yet mental health revenue fell 10% in the quarter and 15% for the year as coverage tightened. Meanwhile, hereditary cancer volumes rose 9% with 3% revenue growth, Prolaris revenue climbed 16% in the quarter on 12% volume growth, and prenatal was stable on revenue despite a 6% volume decline. Cost discipline is evident, with operating expenses down $37 million year over year in the quarter and positive operating cash flow, but the balance sheet also reflects a heavier 2025 impairment and higher debt, underscoring the need for new launches to convert quickly to cash-generative adoption.

This matters now because MRD and AI-enabled risk stratification are becoming payer-gated markets where clinical utility and workflow integration determine share. For patients, earlier detection of residual disease and refined prostate risk calls could change adjuvant therapy decisions and active-surveillance pathways. For clinicians, Myriad’s EMR-linked breast risk platform with Clairity and MagView and the AI-Prolaris readout aim to reduce friction at the point of care. For payers, the bar is rising: MRD will need prospective, real-world evidence that ties detection to de-escalation or escalation decisions and downstream cost offsets; prenatal combinations must prove incremental value over established NIPT and carrier screens. Interim data supporting Precise MRD from a Japanese prospective colorectal study, including 100% baseline sensitivity and highly sensitive post-surgical detection, help the scientific narrative but do not by themselves unlock U.S. coverage.

Across diagnostics, the playbook is converging: prune portfolios, partner for AI rather than build alone, push mix toward oncology and women’s health, and manage to EBITDA while navigating utilization management. Myriad’s sale of international EndoPredict in 2024, ongoing EMR integration, and external AI collaborations reflect that shift. The competitive lanes are crowded—Prolaris contends with Decipher and Oncotype in prostate; Precise MRD steps into an arena shaped by Signatera and Guardant Reveal; FirstGene enters a prenatal market dominated by established NIPT brands—making payer policy and evidence cadence the true differentiators.

The next six months are pivotal. With a 2H-weighted outlook and about $150 million in cash, the launches must secure early clinical champions and near-term coverage wins to sustain guidance. The signal to watch is whether Myriad can convert prescriber interest into payer-backed revenue in MRD and AI-enabled prostate testing fast enough to reset its growth algorithm—or whether 2026 becomes another staging year before a more defensible inflection in 2027.

Source link: https://www.globenewswire.com/news-release/2026/02/23/3243027/0/en/Myriad-Genetics-Reports-Fourth-Quarter-and-Full-Year-2025-Financial-Results-Reiterates-2026-Financial-Guidance-Reflecting-Strengthened-Execution.html

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.