Inflammatory Bowel Disease Computational Diagnostic

helping inflammatory bowel disease patients use long-term thiopurine therapy without adverse effects

Inflammatory Bowel Disease (IBD) significantly reduces the quality of life of 20 million individuals globally and 1.4 million Americans. Presently, treatment options include a very expensive biologic agent-based approach or thiopurine analog therapy. Use of thiopurine analogs is less costly, but it currently requires expensive, imprecise testing to ensure that patients aren’t harmed by long-term use. The University of Michigan has developed and implemented a computational algorithm, ThioMon, which results in highly cost-effective and accurate testing, allowing for a simplified treatment of IBD with thiopurine analogs such as Azathioprine.

Significant Need

The ThioMon technology offers IBD patients a path to a safer treatment option than current testing methods, and thus helps them avoid adverse side effects such as hepatotoxicity, shingles, lymphoma, and other complications of immunosuppression.

Competitive Advantage

The algorithm has a 24-hour turnaround time, versus one-two weeks for other tests, and is more accurate and less expensive than current testing options.

Commercialization Path

  • Intellectual Property – One patent filed and pending, additional patent to be filed for federated LIS architecture use
  • Commercialization Strategy – The test algorithm would be made available as an internationally-offered subscription service from University of Michigan MLabs
  • Regulatory Pathway – Regulatory risk assessment will be occurring. As a reference lab, MLabs can currently offer the test to any hospital or clinic that can ship blood samples to U-M Health System. At present, FDA approval of laboratory-developed tests is not necessary

Milestones

  • Final selection of a local research partner to carry out the split study
  • Local implementation of a full automated pipelined data delivery model, study design, and establishment of study size
  • Execution of subcontract, local/remote IRB review, and continued exploration of establishment of partnered federated laboratories
  • Collection of IBD patient samples for split study analysis
  • Data analysis to validate repeatability at multiple sites
  • Final publication of the findings and activation of first remote commercial clients
  • Q316 Update: ThioMon diagnostic being run at MLabs

May 2, 2017
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