SOURCE: AspenBio Pharma, Inc.

January 28, 2010 08:30 ET

AspenBio Pharma Enters Into Development and Supply Agreement for AppyScore™ Reader

Company Partners With Leading Diagnostic Instrument Manufacturer

CASTLE ROCK, CO--(Marketwire - January 28, 2010) - AspenBio Pharma, Inc. (NASDAQ: APPY), an emerging bio-science company dedicated to the development of novel diagnostics and drugs for humans and animals, announced that it has entered into a strategic relationship with LRE Medical GmbH (LRE) to complete commercial development and manufacture of the reader instrument to be used with the AppyScore™ cassette system.

LRE, a wholly owned subsidiary of Esterline Corporation (NYSE: ESL) is a leader in the development and manufacture of medical devices with a special focus in instruments for point-of-care and near patient testing. LRE is ISO 13485 certified, experienced in manufacturing for IVD and MDD devices requiring the CE mark in the EU, and is registered with the FDA as a contract manufacturer for medical device products.

"We are fortunate to be working with LRE who brings over 40 years of experience in medical device manufacturing and has built a successful track record in developing instruments currently in use in emergency and critical care settings," said Daryl J. Faulkner, Chief Executive Officer of AspenBio Pharma. "LRE provides AspenBio with a proven instrument platform to commercialize our novel assay and strengthens an important part of our supply chain."

The ELISA format of the AppyScore Test is currently in clinical trials for clearance by the FDA and is designed to aid in the evaluation of patients suspected of having acute appendicitis. In addition to the ELISA format, the company has been developing a cassette and instrument format of the test, which will also require separate regulatory clearance prior to commercialization. Under the terms of the agreement, LRE will be the exclusive manufacturer of the instrument and will be responsible for providing the required manufacturing capacity and quality standards necessary to meet global market demands.

About AspenBio Pharma, Inc.

AspenBio Pharma is an emerging bio-science company dedicated to the discovery, development and commercialization of novel products that address unmet diagnostic and therapeutic needs in both human and animal health. The Company's AppyScore blood-based test addresses the difficult challenge of diagnosing human appendicitis in the hospital emergency department. The Company is also advancing unique therapeutic proteins designed to improve reproduction in non-companion animals of economic importance. For more information, go to

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 clearance 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.

Contact Information

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

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