Periodic Reporting for period 1 - BeadCAP-DNA (BeadCAP-DNA: 30-minute on-site DNA test kit)
Reporting period: 2014-10-01 to 2015-01-31
a. validation of market analysis & product definition
b. perform food-DNA trials to assess technical risks & commercial feasibility
c. investigate technology transfer from EU food-analysis researchers
d. investigate technology manufacturing assistance by EU sub-contractors
e. improve our ISO/GMP regulatory affairs & risk-assessment understanding.
Instead of some planned GMO-food-DNA testing, we changed focus to allergens, which has become a topical food-safety issue in recent months. We successfully demonstrated Peanut-DNA capture & detection in our BeadCAP assay.
We signed a technology-transfer agreement with an Italian university to commercialise some of their food-DNA research; AltraTech staff are currently in Italy for training. The director of a French food-quality research institute also visited AltraTech in Ireland, to provide training and consultancy. This may lead to further engagement.
We have received a prototype benchtop reader and cartridges from a German microfluidics company, and are currently embedding our BeadCAP sensor chips into these cartridges. We engaged ISO/GMP experts PBC Ltd to train our team on ISO17025/ISO13485 requirements, risk-assessment, and Design-History-Folder preparation. These technology subcontractor relationships will significantly reduce our implementation and commercialisation risks.