Support: Test FAQs
What is the SimpliPro Colon™ test?
The SimpliPro Colon™ test is a laboratory service available only to healthcare providers designed to enable better compliance for diagnostic colonoscopy for patients presenting with symptoms associated with colorectal cancer. It is a blood based test that measures and analyzes 11 protein markers associated with a risk of colorectal cancer. As a group, these proteins have been found to correlate with a higher or lower risk of positive diagnosis of colorectal cancer and/or advanced adenoma using diagnostic colonoscopy.
The SimpliPro Colon test is a sensitive laboratory-test that fits seamlessly into routine workups for patients with an elevated risk of colorectal cancer.
How does the SimpliPro Colon test work?
The SimpliPro Colon test measures and analyzes 11 protein markers associated with a risk of colorectal cancer which, as a group, have been found to correlate with a higher or lower risk of positive diagnosis of colorectal cancer and/or advanced adenoma using diagnostic colonoscopy.
Which patient population is the SimpliPro Colon test for?
The SimpliPro Colon test has been validated for patients that are at elevated risk for colorectal cancer. For more information about elevated-risk patients, please visit our Target Patients page.
Elevated-risk patients are defined as those who presented with the symptoms observed in the SimpliPro Colon test studies.
How do I order the SimpliPro Colon test for my patients?
If you’d like to learn more about integrating the SimpliPro Colon test into your practice, you can submit a request to our Customer Care team and they will connect you with a representative in your area.
Is the SimpliPro Colon test FDA approved?
The SimpliPro Colon test is a laboratory-developed test (LDT) developed in our Clinical Laboratory Improvement Amendments (CLIA) licensed and College of American Pathologists (CAP) accredited lab. As regulated under CLIA and CAP, this test has not been cleared by the U.S. Food and Drug Administration (FDA). The SimpliPro Colon Test is not FDA approved. FDA clearance or approval is not required for laboratory-developed tests under the agency’s current policies.
How is the SimpliPro Colon test administered?
The SimpliPro Colon test is administered like other blood tests, so there are no new procedures for you or your staff to learn. Patient samples can be drawn from your office or local lab utilizing the blood test workflow you and your staff use every day, or from your patient’s home through our mobile phlebotomy service. For more information about how the SimpliPro Colon test is administered:
- Watch the Instructions for Use video
- Download the Instructions for Use PDF
- Visit the SimpliPro Colon Test Process Page
If you have any questions about administering the SimpliPro Colon test, please contact Customer Care.
Can I ship multiple samples back in the same box?
Yes, you can ship up to six patient samples back to us in the same box. Make sure the box is filled completely with dry ice before shipping any samples (which should require approximately 5 lbs.) and that you include the completed test requisition form for each patient.
What do I do if I don't have dry ice on hand?
If you don’t have dry ice available when collecting your patient’s sample, place the sample in your freezer until the dry ice arrives. All samples must be shipped to our lab on dry ice, as they must be kept cold from the time they are taken to the time they are analyzed.
Do you offer mobile phlebotomy services?
Yes. With the SimpliPro Colon test you can collect your patient’s sample in your office or local lab, or have them schedule an appointment with one of our mobile phlebotomists. Our Customer Care team can help your patient schedule their mobile phlebotomy appointment. For more information on mobile phlebotomy, please visit the SimpliPro Colon Test Process page or contact Customer Care
How are results reported?
The SimpliPro Colon patient test report provides two separate results indicating the probability of a positive diagnosis of colorectal cancer and/or advanced adenoma by diagnostic colonoscopy. The patient test report is faxed to the ordering physician’s office as per HIPAA regulations and guidelines. Click here to see a sample patient test report.
How long does it take to receive a patient's results?
Patient test reports will be faxed to your office within 7-10 business days of receiving the sample at our lab.
Can my patients access their results directly?
We do not automatically send patients their results report. However, they can request a copy by contacting Customer Care.
Is this test covered by insurance?
We anticipate this test will be covered by most Medicare plans and should be covered by many private insurance companies as well. We are in the process of working with private payer insurance companies to secure reimbursement.
Is this test available outside of the U.S.?
The SimpliPro Colon test is currently only available in the U.S.