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Wire · regulatory

FDA Renamed and Updated Its Companion Diagnostics List, Including the First Test That ...

1 August 2026 · By · Wire by Fusion42

Published

1 August 2026

Topic

regulatory

◆ Sectors

Health

◆ Geography

United States

◆ Source

Read at medicaldaily.com →

◆ Verified

Fusion42 · 1 August 2026 · Fusion42 review

The FDA updated and renamed its Companion Diagnostics List to include tests authorised through various regulatory pathways, highlighting the first test that detects cancer recurrence in blood using circulating tumor DNA. New liquid biopsy diagnostics, including expanded coverage for prostate cancer and other cancers, now guide targeted therapy decisions more precisely.

This Wire brief sits within Fusion42's coverage of Health.

◆ ◆ The Wire takeaway

You gain clear regulatory backing to use new blood-based liquid biopsy tests that detect cancer recurrence and guide therapy. That opens clinical conversations and reimbursement pathways worth prioritising now.

◆ Coverage

1 source · 1 Aug 2026

◆ Related on Wire

◆ Topics

HealthFDAcompanion-diagnosticscancer-testingliquid-biopsyoncology