ABSTRACT
US Food and Drug Administration (FDA)-approved diagnostic assays play an increasingly common role in managing patients to prolong lifespan while also enhancing quality of life. Diagnostic assays can be essential for the safe and effective use of therapeutics (companion diagnostic), or may inform on improving the benefit/risk ratio without restricting drug access (complementary diagnostic). This tutorial reviews strategic considerations for drug and assay development resulting in FDA-approved companion or complementary diagnostic status.
Subject(s)
Complementary Therapies/legislation & jurisprudence , Diagnostic Techniques and Procedures , Neoplasms/drug therapy , Precision Medicine/methods , United States Food and Drug Administration/legislation & jurisprudence , Biomarkers/analysis , Diagnostic Techniques and Procedures/economics , Health Services Accessibility , Humans , Insurance, Health, Reimbursement , Molecular Targeted Therapy/methods , Precision Medicine/economics , Quality of Life , United StatesABSTRACT
Early-stage Chinook salmon Oncorhynchus tshawytscha embryos were incubated in artificial redds that mimicked hyporheic conditions in gravel-augmented habitat to assess survivorship. Two complementary experiments were conducted where units varied along gradients of (1) increasing interstitial flow velocity (0·05-2·50 cm s⻹) in a uniformly coarse (particles ≥22 mm) sediment mixture and (2) increasing sediment porosity with interstitial flow velocity held constant. Embryonic survivorship increased moderately along a gradient of interstitial flow velocity, while survivorship among units with varying sediment porosities was consistent. No evidence for flow-induced agitation and mortality was observed. Results suggest that high interstitial flow velocities may confer a moderate advantage for incubating salmonid embryos when conditions that typically reduce embryonic mortality (i.e. low concentrations of fine particles) are ideal.
