FDA Requests Additional Information For AppyScore Test

AspenBio has received a request from the FDA for additional information related to its Premarket Notification 510(k) application for AppyScore test. The application was filed in late June 2009. The AppyScore test is a blood-based test designed to aid in the diagnosis of human appendicitis.

AspenBio said that it is continuing to evaluate the FDA request. The company believes that it will be able to submit the additional data and information within the time period allowed by the FDA, and within the previously disclosed schedule.

In response to the FDA’s request for the additional information, the company proceeded with additional analyses and testing, including supplemental trial work.

Robert Caspari, COO and CMO of AspenBio, said: We believe the data and information submitted in the AppyScore 510(k) is in compliance with applicable regulations. Nevertheless, we anticipated that like most 510(k) premarket notifications that require clinical data, the FDA’s evaluation of our submission would likely result in one or more additional information requests. While there can be no assurance the additional information we provide will successfully address all of the FDA inquiries, we believe we are well positioned to do so.