AspenBio Pharma Days Away From Announcing Pivotal Study Results For First Ever Appendicitis Blood Diagnostics Test
Investors are banking that results are positive, phase II showcased a 98% sensitivity, much higher than required for 510(k) medical device approvals
Dear Traders,
We are currently working on a report which should be out by tonight on a company which truly could become the next game changer within the biotech stratosphere.We've all been waiting for the next HGSI / DNDN, and it seems that AspenBio Pharma (APPY) has quietly tiptoed into the FDA scene.
Barely getting noticed on its impending phase III results for what could be one of the biggest medical breakthroughs of 2010, a medical blood diagnostics test for appendicitis, a condition that affects nearly 10% of North Americans and has a potential $1B market, whereby (APPY) would have no competition in, thus creating a monopoly similar to say Microsoft with Windows.
FDA News
On 2/9/10, APPY reported conclusions from tis pre-planned independent, interim analysis of an ongoing supplemental trial of AppyScore, the first blood-based test designed to aid in the evaluation of patients suspected of having acute appendicitis, and outline the next steps for its AppyScore 510(k) ifling with the FDA. Based on this, approximately 800 patients were enrolled on 3/23/10. APPY estimates that May 4th to 18th the data analysis will be available to include in its pending 510(k) submission to the FDA which will also come in 2Q10.
Highly Positive Results in Phase II
In September 2007, we announced the results of a 471 patient study conducted at multiple hospital sites under appropriate Institutional Review Board Approvals and patient consent. Out of 471 patients, 100 were normal presumably healthy control donors. The 100 normal AppyScore control individuals were used to characterize and confirm the blood level of the proprietary biomarker used in AppyScore in normal healthy individuals. The remaining 371 were patients who entered to the emergency rooms with abdominal pain, with appendicitis as a possible diagnosis. A total of 97 of 311 or 31% of patients had pathology-confirmed appendicitis in the study. AppyScore was able to correctly identify 95 of 97 patients with pathology-confirmed appendicitis. This exceptionally high sensitivity level of 98% for detecting the actual disease condition is considered statistically significant (95% CI = 93% to 99.9%). In addition, the combination of using the data from AppyScore in conjunction with a CT scan resulted in a specificity of 99% (95% CI = 97% to 99.9%).
