To aid in the evaluation of patients suspected of having acute appendicitis
AspenBio Pharma has reported its progress and plans for the premarket notification 510(k) submission of its ELISA format ‘AppyScore’ test. AppyScore is the first blood-based test designed to aid in the evaluation of patients suspected of having acute appendicitis, said the company.
The company claims that previously announced AppyScore supplemental clinical trial continues to advance, with over 400 patients enrolled to-date from the emergency departments of more than a dozen well-known hospitals across the US. Based upon additional analysis of prior trial data, as well as input from a panel of clinical experts assembled by AspenBio’s regulatory consultants, the Statistical Analysis Plan (SAP) for this supplemental trial has now been finalized.
This SAP defines a study end point for the AppyScore test alone, and additionally, adds two alternative end points which evaluate the AppyScore result in combination with either white blood cell count (WBC) or neutrophil count.
For low-risk of having acute appendicitis group, the panel indicated that a test with NPVs as high as those seen in the previous trial data (when analyzed using the combination AppyScore/WBC or AppyScore/neutrophil count) would provide compelling clinical evidence for the test to be widely used in evaluating patients suspected of having acute appendicitis. This panel also prepared a consensus paper expressing their opinion about the expected use of AppyScore in clinical practice.
AppyScore is anticipated to be used as a diagnostic tool to aid emergency department physicians in identifying a subset of patients for whom the risk of acute appendicitis is sufficiently low to support consideration for delaying or eliminating the need for computed tomography (commonly known as a CAT scan) and/or immediate surgical consultation, said the company.
To address the 510(k) and related matters, the company has scheduled a meeting with the FDA in January 2010. One of the objectives of the meeting is to ensure alignment with the FDA with respect to the data requirements necessary to support the proposed intended use and clinical utility of the AppyScore test.