Definitions

Sec. 491.001. DEFINITIONS. In this chapter: (1) "Individualized investigational treatment" means a drug, biological product, or device unique to and produced exclusively for use by a patient, based on the patient's genetic profile. The term includes individualized gene therapy antisense oligonucleotides and individualized neoantigen vaccines. (2) "Life-threatening illness" means a disease or condition with: (A) a significantly increased likelihood of death unless the course of the disease or condition is interrupted; or (B) potentially fatal outcomes and for which the goal of clinical trials is survival. (3) "Severely debilitating illness" means a disease or condition that causes major irreversible morbidity. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984), Sec. 1, eff. September 1, 2025. SUBCHAPTER B. ACCESS TO INDIVIDUALIZED INVESTIGATIONAL TREATMENT