DynaGen
This article was originally published in The Gray Sheet
Executive Summary
Completes Phase I study of its SPT I single-protein tuberculin test and submits application to FDA to begin Phase II studies. Intended for "in vivo use as an aid in diagnosing infection with Mycobacterium Tuberculosis by the standard skin-test procedure," the test's "purity and stability" allow it to "be standardized for quality control purposes," the firm says. DynaGen also believes SPT I "may allow for easier interpretation of skin reactions to TB infection and may produce less of the non-specific reactions characteristic of the current [partially purified protein derivative] test"