AspenBio Pharma's CEO Chats With Us About AppyScore™ Print E-mail
By M.E.Garza   
Friday, 27 July 2012 06:04

icon_qaexclusiveWe recently sat down with Steve Lundy, the Chief Executive Officer and President of AspenBio Pharma (NASDAQ:APPY) whose AppyScoreT is a novel, rapid, blood-based test designed to assist physicians in evaluating acute appendicitis.

The objective of the test is to provide a timely, quantitative measurements of the plasma concentration of MRP 8/14 (also known as S100A8/A9 or calprotectin) an inflammatory response biomarker. The absence of elevated biomarker concentrations, along with other diagnostic indicators, can be correlated with the absence of acute appendicitis. The company's AppyScore test could potentially reduce the number of CT scans performed on low risk patients, and thereby, reduce radiation exposure risk for patients, health care costs, and enhance emergency department efficiency.

Lundy was appointed to the positions of CEO and President on March 24, 2010. Effective on the same date, he was appointed to the Company's Board of Directors. Mr. Lundy brings over twenty years' experience in the medical device and diagnostic industry. He has successfully led the commercial launch of several novel diagnostic assays including the first molecular test for Methicillin-resistant Staphylococcus aureus. He has also been instrumental in transactions involving the sale or merger of several diagnostic companies to larger life sciences entities. Lundy served as CEO of MicroPhage, Inc. He has held senior executive roles at Vermillion, Inc. and GeneOhm which was acquired by Becton Dickinson.

QUESTION- Describe the company product(s) and value proposition

Steve Lundy: Aspen Bio is developing a blood test (AppyScore) to assist emergency room physicians rule out abdominal pain for patients who present with abdominal pain. The test will be run on a small instrument and the test results will come back to the physician in less than an hour.   Currently, there is no approved blood test in this space and physicians order CT scans and other imaging procedure which are both expensive and dangerous.  It is well documented that abdominal  CT scans lead to cancers later in life.  A blood test with high negative predictive value (NPV) could eliminate many of these unnecessary CT scans (most patients who present with abdominal pain do not have appendicitis) and save time and money.

QUESTION- What is the size of the market for the product?

Steve Lundy:  Over 9 million patients present annually to ERs in the US with abdominal pain.  This is the single largest reason for ER visits.  We believe that approximately 6 million of these patients would be candidates for our blood test.  We have not finalized pricing for the test but we believe pricing will be in the $100 range.  When we take into account the international opportunity, we believe the global market size to be in the $1 billion range.

QUESTION- What is the status of the product?

Answer-  In 2011 we completed a 503 patient study across 11 hospitals in the United States.  The performance was excellent; the test performed at a negative predictive value (NPV) of 97%.  Clinicians have indicated that they would be highly motivated to order a test that performs at this level.  Our next step in the US is to complete an FDA pivotal trial which is scheduled to start in Q3 of 2012 and finish in Q1 of 2013.  The FDA trial will be very similar in design to the study we completed in 2011.  We plan to launch in Europe in Q4 of 2012; there is no requirement for an FDA pivotal trial for European launch.

Steve Lundy- Describe the science and intellectual property behind the product

QUESTION:  Our blood test combines the results of three protein biomarkers into a “score” which is calculated using a proprietary software algorithm.   The biomarkers include MRP 14/18 (proprietary to Aspen Bio), C-Reactive Protein and White Blood Count (WBC).  By combining biomarkers, we help ensure the negative predictive value of the test is high no matter when the patient presents to the ER with symptoms.  We have been issued patents for the use of the MRP 14/18 biomarker in appendicitis and have filed patents for the use of the multi-marker panel and our software algorithm.  We feel that our IP protection is very robust.

QUESTION- What is the cash position and runway for the company?

Steve Lundy-  The company just completed a $12 million capital raise.  We believe this will provide the company with sufficient capital to obtain FDA approval for AppyScore and obtain significant clinical traction in the marketplace.

QUESTION- Describe the relevant experience of the executive management team

Steve Lundy- Our senior management team has significant experience launching new in-vitro diagnostic tests into the clinical marketplace.  I have over 25 years of experience in the diagnostics industry and have had fairly significant success.  I recently ran commercial operations for GeneOhm Sciences which launched an infectious disease diagnostic test and sold the company to Becton Dickinson (BD) 18 months later for $230 million. Chief Commercial Officer Don Hurd has 30 years industry experience and has also led high growth commercial efforts.  In addition, the company employs very experienced managers in the critical areas of manufacturing and regulatory affairs.

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