Frequently Asked Questions (FAQs)

Questions about Logistics:

1. What type of blood sample does the test require?

ColonAiQ requires a standard 10ml blood draw in a Streck test tube. Breakthrough Genomics provides these tubes to healthcare providers and partners. Each tube provided contains a special preservative to limit cell lysis and to minimize the degradation of circulating tumor cells during storage and transportation.  Sample collection and shipping instructions are provided for each healthcare provider and lab partner.

2. Is fasting required prior to the blood draw?

No, no fasting is not required for patients prior to the blood draw.

3. How does the shipping work? Does it get picked up or does it get mailed?

A prepaid envelope will be provided to the healthcare provider or partner to be used to ship the sample to the Breakthrough Genomics’ lab in Southern California.  The sample does not need to be ‘spun down’ or refrigerated before shipping.

4. How long can the blood sample last without starting to degrade?

Once in the tube, the blood sample is effective for up to 10 days at room temperature (15-30° celsius) and can be stored and transported without refrigeration.

5. What information should be included on the label of the test tube?

The label on the test should contain the patient name, date of collection, and date of birth.  A test requisition form needs to be filled out in the secure online portal prior to sending the sample. Once the test requisition form is filled out online, a unique identifier code will be provided that should also be included on the test tube label.

6. Is it possible to order Colon AiQ through a printed paper requisition form that is sent through the mail or faxed?

Yes, it is possible to print and fill out a printed version of the Colon AiQ Test Requisition Form. This form can be sent via mail or it can be faxed to 844.804.6756.  If sent via mail please use the following address: Breakthrough Genomics, 2 Hughes #100, Irvine, CA 92618.

7. Can we order the blood draw from a different lab (For example: LabCorp) and have it sent by them to Breakthrough Genomics?

No, the test and blood draw can only be ordered through Any Lab Test Now and other participating partners and health care providers.  Please let us know if you would like to share information on the Colon AiQ with your primary care physician or healthcare provider so that we can get them set up to order the test.  Additionally, providers who don’t normally draw blood at their offices, can request a phlebotomist (professional who does the blood draw) arranged by Breakthrough Genomics to conduct the blood draw either at their office or at the patient’s home.  There is an additional cost associated with this service.

8. Is it possible for doctors to get the results delivered via FAX instead of electronically?

Yes, secure online delivery of test results through our online portal is preferred, but fax delivery of test results is available upon request. Test results are only shared with the licensed partner or healthcare provider and never shared by Breakthrough Genomics directly to patients or their families.

9. Is the test covered by Medicare or private insurers?

Because this test is relatively new in the U.S., Colon AiQ is not yet covered by healthcare insurance providers or Medicare.   We are working to provide coverage for the test through private insurers, HMO’s, and Medicare and will have an update in the coming months.

Please don’t hesitate to email us at for more information on the test and pricing.  We can also help you set-up payment for ColonAiQ in installments as needed.

10. How long after the blood sample is submitted will it take to get the results?

Turnaround times for test results can vary depending on what state you live in and whether the test was ordered by a partner or directly through your healthcare provider.  Partners and healthcare providers who order the test can login to the secure online portal to check on the status of a test.  The providers or partners who helped you order the test will receive an email notifying them when a patient’s report is ready to be retrieved from the portal.

11. Will a patient ever need to submit a second blood sample?

In a very few cases, a patient may be asked to redraw the blood sample because an insufficient amount of cell-free DNA was able to be extracted from the sample. The failure of a given blood sample to meet the lab’s quality control standards has nothing to do with whether a sample is more or less likely to test positive or negative for the presence of colorectal cancer. The request for a second sample of blood happens in less than 1% of cases.

Questions About the Test and it’s Use:

1. Who originally developed the technology?

The underlying technology for this test was initially developed by a bio-engineering Professor at University of California – San Diego named Dr. Kung Zhang.  His pioneering work with using DNA Methylation Signals as an early marker for cancer began in 2009 and is ongoing.  Dr. Zhang is credited as a principal investigator and co-author on 45 scientific publications and is known for his groundbreaking work using NGS technologies to screen for cancer and other previously “unsee-able” conditions.


2. What is DNA Methylation?

DNA methylation is part of the field of epigenetics which looks out how certain regions of DNA in a person’s cells help to regulate gene expression.  This process does not alter the underlying DNA but refers to how often or when specific proteins are created from the instructions within the specific genes in your DNA. While genetic changes can alter which protein is made, epigenetic changes affect gene expression by providing the mechanism by which some genes involved in normal cellular functions can be turned off “on” and “off.”  In recent years, scientists have established through many different studies that unusual DNA methylation patterns can be a bio-chemical signature of cancer.

3. How long has the Colon AiQ test been in use?

ColonAiQ has been in use internationally since 2022 with over 250,000 patient tests administered.  ColonAiQ has received the CE IVD mark from the European Union and is provided exclusively in the U.S. by Breakthrough Genomics’ CAP and CLIA-certifed clinical lab as a Laboratory Developed Test (LDT).

4. What is the recommended interval for patient screening?

The specific interval for use of this colorectal cancer screening test should always be considered on per patient basis by the healthcare provider.  For general screening recommendations, please refer to the Professional Recommendations Section of this website.

In general, shortened test intervals are recommended for individuals deemed to be at an elevated risk or for patients who exhibit other potential signs of the presence of colorectal cancer.

5. What happens if a patient gets a positive result?

All positive tests results should be followed up with a consultation with a health care provider or primary care physician.  It is recommended that positive test results are followed up with a  clinical diagnostic colonoscopy.  Pathology results should be taken into account to confirm the diagnosis.  Similarly, a negative result cannot be used to rule out the possibility of colorectal cancer.

6. What happens if a patient gets a negative result?

A negative result cannot be used to rule out the possibility of colorectal cancer.  Patients should consult with their health care provider or primary care physician to determine when to get a follow-up test.  It is also important to be aware of the symptoms of colorectal cancer. These include:

If you have questions that is not answered here, please do not hesitate to contact us by email or by calling 949-229-0094