AspenBio Pharma, Inc. 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 manufacturing relationship with BBInternational ("BBI") to complete commercial development and manufacture of the AppyScore consumable test cassette.
BBI is a leading OEM provider of lateral flow tests and provides reagents, development services, and contract manufacturing for rapid diagnostic tests for the point-of-care markets.
"BBI has provided us with valuable expertise in advancing our ELISA test to a state of the art quantitative lateral flow format," said Daryl J. Faulkner, Chief Executive Officer of AspenBio Pharma. "Combined with our recently announced alliance with LRE, we now have the major pieces in place for high-volume production of our AppyScore Test and can expand our options for commercialization of this important diagnostic tool."
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 parallel with development of the ELISA format, the company has been developing a cassette and instrument format of the test, which will require separate regulatory clearance prior to commercialization. Under the terms of the agreement, BBI will manufacture the lateral flow test cassette and associated reagents (the "Cassette") and will be responsible for providing the required manufacturing capacity and quality standards necessary to meet global market demand.