Based on molecular fingerprinting, IllumifyDx is a portable and automated medical device that uses liquid biopsies for the monitoring of recurrence and metastasis in Head and Neck cancer patients.
Current Status
We currently have an ongoing study with the Department of Otolaryngology-Head and Neck Surgery at UC Davis, and our current goal in the next year is to have an FDA excempted prototype to be tested at multiple doctor offices. We are currently applying for an NIH STTR grant phase I with UC Davis and an Advanced Industries Early-Stage Capital and Retention Grant from the Colorado Office of Economic Development.
Problem or Opportunity
Methods for head and neck cancer screening and diagnosis have not changed in the last 50 years, resulting in over 60% of patients being diagnosed in late stages and not benefiting from the high survival rate associated with early detection.
Health providers and patients are also challenged by late detection of recurrence and metastasis, and slow monitoring of treatment response to determine responders vs. non-responders.
Solution (product or service)
IllumifyDx is a device initially designed to be used at a doctor's office to screen patients for head & neck cancer, using saliva and blood. It informs the doctor about the patient's status and the best course of action in a timely manner.
The second phase is a device prescribed by the doctor for home use for daily monitoring to assess treatment response, and in case of high-risk patients, for early detection of metastasis and recurrence.
Business model
We acknowledge that the health care market is complex, and we are currently researching the way health care institutions prefer to buy, and in which we can tap into their capital and operational budgets. There are also regulatory and insurance barriers. Hence, we need to:
1. Strategize regulatory applications;
2. Identify insurance billable codes;
3. Sell devices;
4. Sell service contracts.