AspenBio Pharma has submitted its AppyScore blood-based test's pre-investigational device exemption (pre-IDE) to the US Food and Drug Administration (FDA).
AppyScore blood-based test is designed to aid physicians in identifying children and young adult patients who are at low risk for acute appendicitis.
The pre-IDE application, which includes data of more than 500 patient samples collected from the company’s 2011 pilot trial, is submitted in order to obtain the FDA’s guidance regarding the regulatory pathway as well as the proper approach to refine the clinical and statistical plan.
In addition to pre-IDE submission, the company has scheduled a meeting with the FDA prior to the end of the third quarter to work cooperatively on the clinical and regulatory plan.
AspenBio president and CEO Steve Lundy said the pre-IDE submission with the FDA will advance AppyScore towards commercialization.
"Following feedback from our upcoming meeting with the FDA, we plan to initiate the pivotal clinical trial for AppyScore," Lundy added.