Clinical Frequently Asked Questions
Section 1: Description of ColonSentry™
- What is ColonSentry?
- Who developed this test?
- How will this test help me care for my patients?
- What clinical action can be taken as a result of the test?
- If a patient has this test, does it mean they now don’t need a colonoscopy?
- Which of my patients may benefit from a ColonSentry test?
- Is the test approved by Health Canada?
- What is the science behind ColonSentry?
Section 2: Efficacy of ColonSentry
- What studies have been done to validate the clinical effectiveness of the test?
- Does the test detect advanced adenomas?
- Can the test identify flat lesions?
- What is the performance of ColonSentry relative to stool-based screening?
Section 3: Procedural issues – ordering, processing, reporting
- How should a patient prepare for this test?
- How frequently should a patient have a ColonSentry test?
- What is the turnaround time for the test (from blood draw to test result)?
- Where is the test performed and analyzed?
- Can a patient go to any medical laboratory for the blood draw?
Section 4: Other
- Is the cost of the test covered by the government or by private insurance plans?
- Is FDA approval being sought for this test?
Answers
ColonSentry is the world’s first blood-based test for colorectal cancer (CRC). (back to top)
GeneNews™ Corporation, a Canadian company developed ColonSentry. For over a decade, the company has focused on the application of functional genomics to enable early diagnosis and personalized health management based on disease-specific biomarkers. The company has developed a novel approach, the Sentinel Principle®, to detect and stage virtually any disease or medical condition from a simple blood sample. GeneNews is currently applying the Sentinel Principle in major areas with unmet clinical needs such as cancer, arthritis, cardiovascular disease and neurological disorders. For more information about GeneNews, please visit www.genenews.com. (back to top)
3. How will this test help me care for my patients?
ColonSentry helps improve patient CRC screening compliance and provides information for prioritizing patients for colonoscopy. Because ColonSentry is a convenient and patient-friendly colorectal cancer screening option, this test will encourage more patients in your practice to comply with regular CRC screening. The test also stratifies patients as “increased” or “decreased” relative to an average person in the general population to identify which patients should consider having a colonoscopy. (back to top)
4. What clinical action should be taken as a result of the test?
Physicians should consider recommending patients who are asssessed with ColonSentry as having an increased current risk of CRC for a follow-up colonoscopy. In particular, patients that have a current risk result of ≥2 (a current risk of having CRC that is equal to or greater than the current risk of someone whose first degree relative has been diagnosed with CRC) should strongly be considered for a prioritized colonoscopy. For patients who are identified as having a decreased risk of CRC relative to the general population, the physician and patient can jointly decide what future screening is necessary including periodically repeating ColonSentry.(back to top)
5. If a patient has this test, does it mean they now don’t need a colonoscopy?
ColonSentry helps to identify which patients should be prioritized for a colonoscopy. Ultimately these decisions should be made between the physician and the patient. (back to top)
6. Which of my patients may benefit from a ColonSentry test?
ColonSentry is for patients who should be complying with a recommended regular colorectal cancer screening program. This includes everyone between the ages of 50 and 80 who is reluctant to have a colonoscopy or who is averse to fecal-based testing. A simple blood test can be a good first step towards proper screening. ColonSentry is not intended to replace colonoscopy in patients who are already identified and willing candidates for the procedure.(back to top)
7. Is the test approved by Health Canada?
There is no regulatory requirement for Health Canada to approve this type of test. In fact, none of the currently utilized colorectal cancer screening tools or tests are approved or regulated by Health Canada. The tests are validated through peer-reviewed clinical studies and scientific publications. (back to top)
8. What is the science behind ColonSentry?
The ColonSentry test measures the expression of seven genes which serve as biomarkers to detect colorectal cancer. ColonSentry is powered by award-winning Sentinel Principle™ technology and uses quantitative RT-PCR to quantify these genes which are differentially expressed in whole blood taken from CRC patients compared with controls. The resultant panel of seven mRNA biomarkers, from six genes that are upregulated and one that is downregulated in CRC, form the basis of the ColonSentry test. (back to top)
9. What studies have been done to validate the clinical effectiveness of the test?
The validation of ColonSentry has occurred over several years in multiple, blinded controlled experiments. Over 5,000 samples have been collected for these experiments over the last five years. Our first clinical paper on ColonSentry technology was published in Clinical Cancer Research in January 2008. Data was also recently presented at the American Association for Cancer Research (AACR) meeting in March 2008. We recentlt published positive validation data in the International Journal of Cancer. For a list of our publications, please click here. (back to top)
10. Does the test detect advanced adenomas?
ColonSentry assesses the current risk that a patient has CRC. GeneNews is currently developing a test for advanced adenomas. (back to top)
11. Can the test identify flat lesions?
ColonSentry assesses a patient’s current risk of having CRC, which may include flat lesions. It is not known whether flat lesions are detected with ColonSentry. (back to top)
12. What is the performance of ColonSentry relative to stool-based screening?
The sensitivity of fecal based testing varies widely. The sensitivity of ColonSentry is at the very upper end of this range. Moreover, the fact that ColonSentry is a simple blood test enhances patient acceptance and thus significantly increases compliance. Thus the overall program sensitivity of ColonSentry which depends on both test performance and patient compliance is expected to far exceed that of any available fecal programs. (back to top)
13. How should a patient prepare for this test?
No bowel preparation is required for the ColonSentry test. Patients do not need to fast before having this test and it is not necessary for them to alter their medications or diet either. Patients simply have to present a standard OHIP laboratory requisition form that has been filled out by a licensed physician to a participating laboratory to get their blood sample drawn. (back to top)
14. How frequently should a patient have a ColonSentry test?
ColonSentry can be ordered as a stand-alone test or with other tests as part of a comprehensive physical examination. There is no standard frequency with which ColonSentry should be ordered, but it makes sense to include it along with other routine tests as part of your patient's regular check-up. As with all screening tests, ColonSentry is not a one-time test. It must be repeated at regular intervals for maximum effectiveness because a patient's current risk result has no bearing on their future risk of developing colorectal cancer.(back to top)
15. What is the turnaround time for the test (from blood draw to test result)?
The results will be sent to the referring physician in five business days from date of receipt of the blood sample. (back to top)
16. Where is the test performed and analyzed?
The blood draw will take place either at an eligible independent medical laboratory or clinic. This routine blood draw is performed similarly to many other blood draws. The blood is drawn by a healthcare professional. The blood sample is then shipped to GeneNews’ ISO certified laboratory facilities where it is analyzed by certified medical technologists. (back to top)
17. Can a patient go to any medical laboratory for the blood draw?
No. To guarantee results of the highest possible standards, GeneNews currently accepts only a few participating laboratories and clinics. For a full list of laboratories and clinics that are accepting blood samples for the ColonSentry test, please refer to this page. (back to top)
18. Is the cost of the test covered by the government or by private insurance?
Currently, ColonSentry is being offered directly as a self pay service. The test may also be covered by a patient’s medical benefits provider, either by their employer or through their insurance plan. GeneNews is actively working with private payers to secure additional coverage for ColonSentry . (back to top)
19. Is FDA approval being sought for this test?
GeneNews is launching ColonSentry in Canada as a first step and is working actively at the same time to secure international approval for this novel technology. FDA approval is a top priority. (back to top)