APPY1 regulatory update

Venaxis said FDA issued a not substantially equivalent response to the company’s 501(k) application for APPY1 to aid emergency room clinicians in identifying patients at low risk for appendicitis in individuals ages 2-20 with abdominal pain. Venaxis said it is reviewing the FDA letter and will evaluate its alternatives. The company said the alternatives include continuing to seek U.S. approval for APPY1, exploring study protocols to address matters identified by the agency, assessing the acceleration of the company’s APPY2 next-generation test and pursuing its “commercial advances being made in Europe.” ...