2014

AspenBio Pharma Pursues FDA 510(k) Application Pathway for Appendicitis Blood Test Company now officially following an FDA 510(k) (Pre-Market Notification)

Pathway for AppyScore(TM), the First Blood-based Screening and Triage Test

for Human Appendicitis



    CASTLE ROCK, Colo., Nov. 27 /PRNewswire-FirstCall/ -- AspenBio Pharma,
 Inc. (Nasdaq:   APPY) an emerging bio-pharmaceutical company dedicated to the
 development of novel drugs and diagnostics for animals and humans, has
 received an official response from the Food and Drug Administration (FDA)
 Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) regarding
 AspenBio's pre-investigational device exemption ("IDE") application on
 AppyScore(TM), the first blood-based screening/triage test for human
 appendicitis.
 
     The official response from FDA has provided the company with the choice
 of pursuing either an FDA 510(k) (Pre-Market Notification) regulatory
 clearance or a PMA (Pre-Market Approval) for AppyScore. Based on this
 response, the company has now officially chosen to follow the 510(k)
 pathway. Generally the FDA's 510(k) application pathway has a much shorter
 time-line to clearance than the alternative PMA process. The company
 expects to complete the appropriate regulatory requirements to receive a
 510(k) clearance for AppyScore before the end of 2008.
 
     "This represents another major milestone in the advancement of our
 breakthrough screen test for appendicitis," said AspenBio's president and
 CEO, Richard Donnelly, "and demonstrates the strength of our initial
 clinical results and particularly the high sensitivity of AppyScore. We
 expect the FDA 510(k) to be a faster and easier path for regulatory
 clearance and market launch of this product. Most importantly, it creates
 the possibility of being able to begin marketing the first version of this
 test in the United States and certain international markets in 2008."
 
     About AppyScore and the Need for a New Method of Diagnosing
 Appendicitis
 
     AspenBio's AppyScore is the first blood-based Screen/Triage Test for
 human appendicitis. An estimated 5% to 7% of the world's population will
 get appendicitis in their lifetime. Annually, in the U.S. alone, an
 estimated 6 million patients enter hospital emergency rooms (ERs)
 complaining of abdominal pain, and who could potentially have appendicitis.
 Upon entering the ER, the current standard of care for these patients is to
 draw blood and urine samples, take vital signs and complete an initial
 physical health examination. Depending upon the results and clinical
 impression of the ER physician, a computed tomography (CT) scan may also be
 scheduled to assist in the diagnosis or rule out of appendicitis. CT scans
 generally take several hours to schedule and complete the procedure, and
 interpret the results. Moreover, CT scans are expensive, costing $1,500 to
 $3,000 each, and subject patients (mostly children and adolescents) to high
 levels of ionizing radiation.
 
     Based upon the current standard of care, an estimated 700,000 patients
 in the U.S. are diagnosed with appendicitis and have their appendixes
 surgically removed. However, an estimated 1 in 5 to 1 in 7 (14% to 20%)
 appendectomy surgeries remove a normal appendix due to an incorrect
 diagnosis. This would mean more than a 100,000 unnecessary surgeries occur
 every year at a great cost to patients, insurance companies and create
 unnecessary pain, suffering and risk to human life and possibly other
 ongoing patient health issues.
 
     Not properly detecting real cases of appendicitis is also a major
 problem. A large independent research report (Graff et al., 2000 Acad Emerg
 Med Vol 7 n 11 pp 1244-55) of approximately 1,026 appendicitis patients
 from 12 hospitals across the northeastern United States reported that an
 average of 18.6% of patients (ranging from 10.6% to 27.8% per hospital)
 were incorrectly diagnosed as not having appendicitis and were sent home,
 only to return to the emergency room with acute appendicitis in an advanced
 or burst condition. If the Graff report is representative of the
 state-of-the-art diagnostics for appendicitis, then the 98% sensitivity
 level of AppyScore -- as reported by company's recent large-scale
 multi-hospital study -- demonstrates the substantial impact this screening
 test could have for life threatening misdiagnoses. The false negative
 diagnosis of appendicitis could become much less frequent using AppyScore,
 resulting in fewer patients with appendicitis being erroneously sent home.
 
     About AspenBio Pharma, Inc.
 
     AspenBio Pharma is an emerging bio-pharmaceutical company dedicated to
 the discovery; development, manufacture, and marketing of novel proprietary
 products, including those that enhance the reproductive efficiency of
 animals and that have large worldwide market potential. The company was
 originally formed to produce purified proteins for diagnostic applications
 and has become a leading supplier of human hormones to many of the nation's
 largest medical diagnostic companies and research institutions. The company
 has successfully leveraged this foundational science and technology
 expertise to rapidly develop an enviable late-stage pipeline of several
 novel reproduction hormone analogs for wide-ranging therapeutic use
 initially in bovine and equine species. AspenBio Pharma continues to
 advance the development and testing of its two first-generation blood-based
 human diagnostic tests designed to rapidly help diagnose or rule out
 appendicitis in patients complaining of abdominal pain. For more
 information, please visit: http://www.aspenbiopharma.com.
 
     Forward Looking Statements
 
     This news release includes "forward looking statements" of AspenBio
 Pharma, Inc. ("APPY") as defined by the Securities and Exchange Commission
 (the "SEC"). All statements, other than statements of historical fact,
 included in the press release that address activities, events or
 developments that APPY believes or anticipates will or may occur in the
 future are forward- looking statements. These statements are based on
 certain assumptions made based on experience, expected future developments
 and other factors APPY believes are appropriate in the circumstances. Such
 statements are subject to a number of assumptions, risks and uncertainties,
 many of which are beyond the control of APPY. Investors are cautioned that
 any such statements are not guarantees of future performance. Actual
 results or developments may differ materially from those projected in the
 forward-looking statements as a result of many factors, including the
 ability to successfully complete the development of, obtain FDA clearance
 for and generate revenues from the appendicitis test and other new
 products, execute agreements required to successfully advance the company's
 objectives, retain the scientific management team to advance the products,
 overcome adverse changes in market conditions and the regulatory
 environment, fluctuations in sales volumes, obtain and enforce intellectual
 property rights, and realization of intangible assets. Furthermore, APPY
 does not intend (and is not obligated) to update publicly any
 forward-looking statements. The contents of this news release should be
 considered in conjunction with the warnings and cautionary statements
 contained in APPY's recent filings with the SEC.
 
 
For more information contact: AspenBio Pharma, Inc. Gregory Pusey, Chairman Tel 303-722-4008 Investor Relations: Liolios Group, Inc. Scott Liolios or Ron Both Tel 949-574-3860

SOURCE AspenBio Pharma, Inc.

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