We primarily set out to meet 4 particular goals, which were addressed in our design criteria:

Specificality:

Testing for Colorectal Cancer only using miRNA biomarkers (miR-21 and the miR-17-92 cluster) and antibodies

Accuracy:

Lower false positives + detect GIT bleeding from cancerous polyps using FIT (with Actinobacteria) and ELISA, improving customer rapport.

Accessibility:

Lower out of pocket cost to the patient.

Scalability:

Making the test available on a mass scale through a take home kit that is sent to a lab for analysis

 

Our full design criteria are as follows:

Primary criteria: 

• Positive results of the test must equate to a statistically significant positive colorectal cancer diagnosis through the use of fecal occult blood.
• Administration of the test should be completed by the patient without health care assistance until the test is shipped to a laboratory. 
• The product must remain with the same user interface and procedure as a standard FIT.
• Accuracy of the test should not be contingent on dietary/medication considerations. This includes but is not limited to current gFOBT dietary constrict (red meats, some fruits and vegetables, etc.) and inflammatory medications (NSAIDs, vitamin C, etc.).
• Prescription for the test must not be required and price of manufacturing for the test must be under the standard rate for a colonoscopy screening with health insurance coverage at a standard hospital. ($1,855). [1]
• The test contents are prepared to be sold over the counter at a pharmacy.

The test should also ideally meet the following conditions:

• The price at market for the test must be under the standard rate for an over-the-counter fecal immunochemical lab based test at CVS Pharmacy. (~$30). [2]
• The SCHIT’s statistical accuracy in screening for colorectal cancer is greater than or equal to that of a colonoscopy.

These constraints ideally allow our test to be a cheaper, non-invasive colonoscopy alternative that can be bought over the counter at a reasonable price.