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Foundation Medicine: risk summary

Summaries are drawn from public sources and link to them. HSH does not give a risk rating: read the summary and sources and reach your own view. Unproven allegations are labelled as such. Suppliers can submit a response, which is shown alongside.

Financial

Latest full-year results from official filings.

Parent Roche (ROG.SW) group FY2025 revenue CHF 61.52bn (+2.0%); core operating margin 35.5%; net income CHF 13.80bn.

Diagnostics division sales CHF 13.85bn (+2% at constant exchange rates).

Researched 8 Nov 2026

Adverse media

Credible news about incidents, disputes, legal action or restructuring in the last 24 months.

No adverse media involving Foundation Medicine found in HSH's search of the last 24 months.

Researched 10 Nov 2026

Cyber & information governance

Data breaches, cyber incidents, regulator action and assurance status.

No data breaches, cyber incidents or regulator action involving Foundation Medicine found in HSH's search of the last 24 months. NHS DSPT status not yet checked.

Researched 10 Nov 2026

Regulatory & clinical safety

Recalls, safety notices, regulator action and clinical safety concerns.

Mar 2026: Foundation Medicine began a US Class 2 recall of three lots of a sequencing reagent used with FoundationOne CDx, after a possible increase in phasing that could cause false-positive BARD1 variant calls; affected units were quarantined for replacement.

Researched 10 Nov 2026

Contract performance

Contract delivery, go-lives, terminations and disputes.

May–Jun 2026: the FDA approved FoundationOne CDx as a companion diagnostic for several new cancer therapies, including tepotinib (MET NSCLC) and inavolisib (PIK3CA breast cancer). No contract disputes found.

Researched 10 Nov 2026