CLSI MM23-1st

Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)

Body

CLSI

Number

CLSI MM23-1st

FDA recognition no.

7-269

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Section 1.4.2 Definitions of correlated biomarker, integral biomarker, and integrated biomarker. Section 2.1.3 Prognosis, Sentence 25-26 addressing genetic mutations Table 3 Examples of Correlation of Somatic Changes with Response to Therapy Table 4 Selected Germline Genetic Variants Used to Predict Optimal Dosage Section 2.4.3 Establishing Clinical Validity

Scope source: FDA 认可共识标准库

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