Epidermal Growth Factor (EGFR) tests [Tissue-based EGFR PCR Mutation Test] for diagnosis of EGFR mutations in patients with NSCLC

Cycle 4 | Clinical Equipment and Devices

HTA Council Recommendation (as of 18 March 2026)

As final recommendation, the HTA Council recommends tissue-based EGFR PCR Mutation Test for the diagnosis of EGFR mutations in patients with non-squamous NSCLC; and, for patients diagnosed with squamous NSCLC aged <50 years old, regardless of smoking history, for government financing. The Council further recommends adherence to the recommended specimen by the WHO to be used in testing [i.e., Formalin-Fixed, Paraffin-Embedded (FFPE) tissue].

Relevant Information

  • Status:With Final HTA Council Recommendation and SOH Decision
  • Topic Assignment: Internal Assessment
  • Policy Question: Should tissue-based EGFR PCR Mutation Test for the diagnosis of EGFR mutations in patients with non-squamous NSCLC; and, for patients diagnosed with squamous NSCLC aged <50 years old, regardless of smoking history, for government financing be funded by the government?
  • Secretary of Health Decision: Approved as of 30 April 2026

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