mChip: Handheld Disease Diagnostics Samuel Sia

Assistant Professor of Biomedical Engineering Columbia University Co-Founder of Claros Diagnostics

ELISA = the "gold standard"

ELISA objective result high sensitivity quantitative (if needed)

rapid test subjective interpretation of signal low sensitivity qualitative only

First product: prostate cancer monitoring >30,000 deaths per year in U.S. (second leading cause of cancer deaths among men) PSA to monitor relapse

Can a sensitive and quantitative PSA test be offered in a doctors office?

Demonstration

ELISA signal generation light source detector manufacturing enzyme/substrate reaction lasers, lenses, filters photomultiplier tubes plastic 96-well plates

mChip silver precipitation (photography) LEDs (ambient lighting) photodetector (photocopier) injection-molded plastic (consumer toys)

Adjahoun-Fiagbe, Togo, 2001

Popular Science, 2010

ELISA accuracy speed sample volume cost of equipment & per assay high 3 hours venipuncture $100,000 cents in materials

mChip same as ELISA 12 minutes finger prick or less (down to 1 mL) $100 cents in materials

Where we are at: 1st world product...

...and 3rd world product

Completed Pre-Clinical Trials in the field (R&D funded by Wallace Coulter Foundation and NIH/NINR) Completed Business Plan (detailed analysis with VITA) Available Intellectual Property (Claros Diagnostics will make IP accessible)

the "funding gap": a sustainable emerging technology for the developing world? for-profit, 1st world (investors) non-profit, 3rd world (philanthropy)

Long-term strategy grants to launch product on the market once on the market: financially self-sustainable, millions of lives saved at dollars/DALY Short-term steps (12 to 18 months, < $1M)

Obtain clinical-trial data from 5 to 10 clinics in Rwanda (STD testing for maternal/child health) for evaluation from MOH, WHO & funders
LAUNCH provide suggestions on funding mechanism form strategic implementation partnerships