AspenBio Pharma, Inc. Says It Chooses FDA 510(k) Application Pathway For Appendicitis Blood Test

(RTTNews) - AspenBio Pharma, Inc. (APPY | charts | news | PowerRating) on Tuesday said it received an official response from the Food and Drug Administration Office of In Vitro Diagnostic Device Evaluation and Safety regarding AspenBio's pre-investigational device exemption application on AppyScore, the first blood-based screening/triage test for human appendicitis. The company said the official response from FDA provided the company with the choice of pursuing either an FDA 510(K | charts | news | PowerRating) regulatory clearance or a Pre-Market Approval for AppyScore.