A Push to Tie New Drugs To Testing.

CLINICAL drug trials; CHEMGENEX Pharmaceuticals Ltd.; UNITED States. Food & Drug Administration; LEUKEMIA; GENETIC mutation; TUMOR genetics; PATIENTS

ChemGenex Pharmaceuticals found out the hard way how important it is to have a trustworthy companion. The Food and Drug Administration last year rejected the company's drug to treat a subset of leukemia patients whose tumors had a particular genetic mutation. The main problem was not the drug itself, the agency said. Rather, ChemGenex had not specified a companion test that could reliably detect the mutation so that the drug could be given to the patients it is intended to help. [ABSTRACT FROM AUTHOR]