AspenBio Pharma Files 510(k) Notification With FDA for AppyScore(TM) Test

CASTLE ROCK, CO, Jun 30 (MARKET WIRE) --
AspenBio Pharma, Inc. (NASDAQ: APPY), an emerging bio-science company
dedicated to the development of novel diagnostics and drugs for humans
and animals, has filed a Premarket Notification [510(k)] with the U.S.
Food and Drug Administration ("FDA") for its AppyScore(TM) Test, the
first blood-based test designed as an aid in the diagnosis of human
appendicitis.

"This FDA 510(k) submission represents a major milestone in advancing our
AppyScore appendicitis test platform toward commercialization," said Daryl
Faulkner, chief executive officer of AspenBio. "The experienced group that
has prepared this submission including experts inside and outside of the
company has produced a complete, highly professional and quality
submission package."

The 510(k) filing as submitted describes the following indication of use:

"The AppyScore(TM) Test is an ELISA test system that is used to
quantitatively measure S100A8/A9 heterodimer complex in blood. It is an in
vitro diagnostic device that is intended to be used as an adjunctive tool
for the diagnosis of acute appendicitis in conjunction with additional
diagnostic modalities (such as clinical exam, basic laboratory testing,
imaging) in patients with abdominal pain that is suspicious for acute
appendicitis."

AppyScore is a new in vitro diagnostic test designed to help health care
professionals accurately diagnose acute appendicitis when used in
combination with standard diagnostic modalities and a clinical
examination. For this urgent and oftentimes difficult to diagnose and
potentially life threatening disease, clinical trial results indicate
AppyScore has sufficient sensitivity and specificity to be a useful
adjunctive diagnostic tool in an emergency department setting.

Summarized below are the data included in the 510(k) submission at the
original test threshold ("cut-off") of AppyScore at 20 units. The study
design allowed for supplemental analysis of alternative cut-off values for
optimizing the utility of the device and the table also includes data at
the cut-off of 14 units from that supplemental analysis.

510(k) Submission Data
----------------------
Cut-off = 14 Cut-off = 20
------------ ------------
AppyScore Value (95% CI)

Sensitivity 90% (85-93) 77% (71-82)
Specificity 33% (28-37) 48% (44-53)
Negative Predictive Value 87% (81-91) 81% (76-86)

A value of 14 units provides a meaningful improvement in sensitivity
which is optimal for a test that is designed to help aid in the
evaluation of patients presenting with symptoms suggestive of a
potentially serious health outcome.

This filing advances the company's commercialization plan for AppyScore,
which involves initially filing the 510(k) based on the ELISA test format.
Upon receiving market clearance for this device, the company plans to use
the ELISA device as a predicate for a rapid assay device that includes a
reader instrument. The company has been advancing the development and
testing of this rapid assay and reader instrument, which has progressed to
late prototype stage.

This rapid assay system represents the format the company plans to
ultimately commercialize, since it offers many features and benefits over
an ELISA-based test. It can produce results in approximately 15 minutes,
which in turn can be rapidly and accurately uploaded to a hospital's
Laboratory Information System (LIS) via a built-in electronic interface.
More importantly, as a fully integrated, stand alone assay system, it can
significantly reduce operator dependence and corresponding potential for
errors.

AspenBio plans to begin initial hospital testing of the rapid assay device
in late 2009. Assuming the company receives FDA clearance of the AppyScore
ELISA test and development work is completed, clinical trials of the rapid
assay are planned to begin in early 2010. These follow-on trials will be
designed to support a 510(k) submission for this rapid assay platform
using the ELISA test as a predicate, as well as to provide physicians with
additional information on the product's utility.

About AspenBio Pharma, Inc.

AspenBio Pharma's mission is to be a leader in the development and
commercialization of innovative products that address unmet diagnostic and
therapeutic needs in both Human and Animal Health. Our Human Health
Division is addressing the difficult challenge of diagnosing appendicitis
in the hospital emergency department setting. Our Animal Health Division
is focused on therapeutic proteins that support reproductive efficiency in
animals of economic importance.

For more information, go to 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 ("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 statements regarding the ability to successfully
complete the clinical trial data assessments required for FDA submission,
obtain FDA approval for, cost effectively manufacture and generate
revenues from the appendicitis test as well as the animal products 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.

Company Contact:
Gregory Pusey
Vice Chairman
Tel 303-722-4008

Investor Relations:
Liolios Group, Inc.
Email Contact
Ron Both or Geoffrey Plank
Tel 949-574-3860

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