1. Is this product available for markets outside of Canada?

Yes. ArcticDx has begun discussions with potential partners for world-wide distribution. Interested parties should contact the company.

2. What is the 'Field of Use'?

Molecular Diagnostic; SNP genotyping.

3. Where will it be used?

1. Screening people with a family history of colorectal cancer.
2. Screening people over the age of 50 to identify high risk people for colonoscopy.
3. Screening people for risk assessment prior to other molecular diagnostic procedures related to colorectal cancer. Early detection molecular testing is evolving but it is expensive. Payers may want only high risk patients to receive these new expensive diagnostic applications.

4. Who will use the invention?

1. Primary Care Physicians, Gastroenterologists and Oncologists will order the test.
2. Laboratory technicians will run the test in a molecular lab.

5. What is the problem this invention addresses?

1. At the present time screening programs for colorectal cancer are reimbursed, but the two mainstream applications (fecal occult blood test, FOBT and Colonoscopy) generate very poor compliance (< 20%) due to the nature of the test material (FOBT) and the invasive component of colonoscopies.
2. It is well recognized that early detection of colorectal cancer improves outcomes, and patients over 50 are urged to comply. This test will identify patients risk from a simple blood test taken during a routine physical examination. High risk patients will be more compelled to comply with colonoscopy and FOBT.
3. Gastroenterologists will finally have a tool to drive compliance with colonoscopy. Primary care physicians will similarly have a tool to increase compliance with FOBT.

6. How would you describe the Colo-Risk™ test?

The invention is a series of single nucleotide polymorphisms (SNP's) that are included in a genotyping assay. Assay results are then analyzed in an algorithm that considers the genotyping result as well as other risk factors including age, body mass index etc. The final test result will classify the patient as low, medium or high risk for lifetime development of colorectal cancer.

7. What is the main function of the invention?

Colo-Risk is intended to identify a person's lifetime risk for the development of colorectal cancer.

8. What are the step-by-step summary instructions for use?

1. Physician performs routine medical examination including Body Mass Index.
2. Physician informs the patient about the test (informed consent?)
3. Physician takes a blood sample from the patient.
4. Physician completes a lab test order form and sends sample to the lab.
5. The laboratory extracts the DNA and runs the test using a Roche Lightcycler.
6. The assay results from the Lightcycler are fed into the software algorithm.
7. The patient information (Body Mass Index, Age, etc) are fed into the algorithm.
8. The patient result is generated in a report that is approved by the lab director.
9. The report is sent to the primary care physician and the gastroenterologist.

9. What products will it replace?

ArcticDx believes that Colo-Risk will replace FOBT.

10. What are the significant advantages?

1. The payer can control patients receiving colonoscopy.
2. The payer can screen only high risk people.
3. Healthcare outcomes studies will demonstrate savings across the healthcare system.
4. The physicians will identify the right people for screening.
5. The Gastroenterologist will screen more patients (improved compliance).
6. The healthcare system will see a reduction in colorectal cancer.
7. A proposed reduction in patient morbidity and mortality from colorectal cancer.

11. What is new with regard to the invention?

This test represents the first and the only molecular test for lifetime risk to colorectal cancer.

12. What is your estimate of the cost of the test?

Genotyping Test (up to 12 SNP's) @ $300.00US

13. What is your estimate of the market potential in units?

Annual volumes at least 1% of the target market

1. USA = 3 million tests per year.
2. Canada = 300,000 tests per year.

14. Have tests been conducted to confirm the advantages?

1. Final tests are in process to establish sensitivity, specificity, positive predictive value and negative predictive value.
2. We are also planning outcomes studies (healthcare economic studies) which are scheduled for completion in 2008.

15. What is the patent status?

1. Three patent filings have been made. Two filings in 2006, one in 2007.
2. Copies are available only under Confidential Disclosure Agreement.
3. The IP is owned by Cancer Care Ontario and licensed exclusively to ArcticDx Inc.

16. What is the status of development?

1. A Canadian university medical laboratory has been contracted to run the final analytical and clinical validation samples. The lab has been audited to FDA specification (CLSI guidance document MM1-A2 etc.)
2. A Pre-IDE submission including the study protocol is being prepared for the FDA.
3. The test will be commercialized in Canada in 2008 by the Canadian university hospital laboratory.

17. Has the performance been demonstrated?

The SNP association studies have been completed in 6 controlled studies involving more than 16,000 patients from five (5) countries (Canada, USA, England, Scotland and France). Some of the results are published.