1. BIOMARKER COMMERCIALISATION the challenges and opportunities from the perspective of a lean and mean SME. Peter Maguire, CEO, MC Diagnostics Ltd

2. MC Diagnostics Incorporated : –June 2006, by Maguire and Crosby Aim: –To develop a new platform for automated molecular diagnostics. To date: –A team of 13 people –ALDAS: Automated Low Density Array System

4. ALDAS Processes low density arrays printed into the bottom of microtiter wells. Arrays may use proteins or nucleic acids. Niche –multiple biomarkers in a single test. –Rapid turnaround –Flexible sample numbers –Full automation after pcr

5. Test principle: Miniature reverse SSO “blot” DNA Isolation PCR Test processing Data Interpretation

6. 4 key developments The ability to print oligonucleotides efficiently into the bottom of microtiter wells. The assay process and its automation Software to capture images and interpret the data. DNA probe specification and testing

7. 1 st Application HLA Typing (Tissue Typing) for transplantation –A range of 6 different amplifications and arrays to type both Class I and Class II Human leukocyte antigens. –Allows fast typing in transplant situations. –Allows low or high throughput with medium/high resolution for patient lists. –Licensed to BAG HealthCare for sales and marketing

8. MCD the next step We have an enabling technology, suited to –More than 10 signals per test –Rapid test turnaround –High or low throughput –Cost limited applications –Targeted genotyping/phenotyping producing only the desired answers, without irrelevant information –Relatively quick turnaround on new test designs We are ready for more biomarker collaborations

9. Biomarker Commercialisation It’s a team game! BIOMARKER DISCOVERY Adaptation to assay platform Validation and verification Manufacturing Sales and Marketing Basic Science “Customer “ Need

10. Picking the right team Is it one Biomarker or a family of markers? –Will there be more to follow? Which assay platform is most appropriate for the output required? –Are there key requirements which direct the choice e.g. speed of test, throughput. Which league should we be playing in? –What level of acceptance is there for this biomarker? –What is the value of the test? –What is the frequency of testing? –Is the market established or new? Who is taking the financial risk? –What degree of risk exists?

11. Biomarkers – a high risk proposition? Keeping a team focussed on the same goals is more difficult than an individual. Having the finance to invest in the right place at the right time can be a nightmare. So, how can SME’s get involved and stay involved?

12. UK plc – driving the cogs of Industry? Biomarker commercialisation Biomarker Discovery UK plc Finance Success