AspenBio Pharma Inc announces 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.