Why it is profiled?The clinical trial results of appendicitis blood test system due to be released soon.
AspenBio Pharma Inc.(APPY) is an emerging bio-pharmaceutical company focused on advancing towards commercialization, its first-generation AppyScore test to aid in the diagnosis of human appendicitis and several novel reproduction drugs for use in high value animals.
Appendicitis is an acute event characterized by inflammation of the appendix. Failure to accurately diagnose and treat appendicitis before it perforates or bursts can lead to serious complications and, in some cases, even death.
Aspen's first-generation AppyScore test is designed to rapidly aid in the diagnosis of appendicitis in patients complaining of abdominal pain. The company completed patient enrollment for its AppyScore pivotal clinical trial last month. A total of 800 patients have participated in the trial.
On March 23, AspenBio said that it would take about six to eight weeks to independently review and validate final clinical and assay data and statistical analysis. The company intends to complete the FDA 510(k) submission this quarter (Q2).
According to the company, AppyScore test will take less than 45 minutes to diagnose or rule-out appendicitis , compared to a CT scan that typically takes 3-5 hours or longer to obtain results. It is estimated that over $1.0 billion is spent annually in the U.S. on CT scans to diagnose appendicitis.
If successfully developed and cleared by the FDA, AspenBio's patented AppyScore test will be the only blood-based test designed to aid in the evaluation of appendicitis in the worldwide market.
The company's pipeline also includes reproduction drug products for cattle - BoviPure LH and BoviPure FSH. AspenBio had licensed the two drug products in 2008 to Novartis AG (NVS) under a long-term world-wide development and marketing agreement and are currently advancing in the FDA approval process.
From inception, AspenBio has been generating revenue from its human antigen business. In 2009, the company reported revenue of $291 thousand, compared to $821 thousand in 2008. Net loss in 2009 widened to $15.5 million or $0.47 per share from $9.6 million or $0.31 per share in 2008.
APPY, which hit its yearly low of $1.30 on Dec. 17, 2009, touched a new intraday high of $3.65 on Thursday (April 22), before closing the day's trading at $3.30 on a volume of 3.3 million shares.
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