Why Colvera?

Because the truth matters.

Currently, the standard blood test used to monitor colorectal cancer patients for recurrence is carcinoembryonic antigen (CEA). Although CEA has been used for over three decades to monitor patients, the test may yield false positive results that can be caused by smoking and other non-cancerous conditions.1

“CEA is insufficiently sensitive to be used alone. It is therefore essential to augment CEA monitoring with another diagnostic modality in order to avoid missed cases.”2

“[The goal of monitoring] is not simply the detection of recurrence, but the ability to detect recurrent disease as early as possible to facilitate intervention and cure.”3

Colvera is a simple blood test that identifies the presence of two altered genes, BCAT1 and IKZF1, in ctDNA, when present show a high concordance of colorectal cancer recurrence. Colvera may help you make a more informed decision about whether additional follow-up, such as radiological imaging, should be considered.

In a recent clinical study, Colvera detected twice the number of recurrent CRC cases compared to CEA. Of 122 patients who were tested after completion of their initial therapy, 28 patients developed recurrent disease. Colvera detected recurrence in 19 of these 28 patients compared to only 9 of 28 patients detected by CEA.4

Using Colvera in combination with CEA can provide additional information to help you more confidently monitor your patients and possibly identify CRC recurrence before symptoms present and cancer has spread to other areas of the body.

In a head to head clinical evaluation, Colvera detected 2x more CRC recurrences compared to CEA.

Frequently Asked Questions

What is Colvera?

Colvera is a blood test that helps healthcare providers detect colorectal cancer (CRC) recurrence. With Colvera it may be possible to identify CRC recurrence  in advance of symptoms, and possibly before other tests indicate recurrence.

How does Colvera work?

Colvera is a qualitative test designed to help detect colorectal cancer (CRC) recurrence by indicating the presence or absence of two methylated or altered genes often associated with CRC, BCAT1 and IKZF1, in small fragments of genetic material that leak from a tumor into the blood stream called circulating tumor DNA or ctDNA. Methylation is a chemical change associated with cancer development, in circulating tumor DNA.

Unlike DNA mutations, which are frequent in cancer, but may vary widely between patients and undergo mutation shifts during the course of disease, methylation is a chemical change associated with cancer development, in circulating tumor DNA that occurs early, is persistent and is readily measured. Colvera is not intended to stratify the risk of recurrence in colorectal cancer patients, but rather to measure circulating tumor DNA at the time testing. While Colvera detects changes found in most recurrent tumors, Colvera may not be positive in all patients. Colvera does not identify DNA changes that may have been inherited from parents or passed on to children.

What is the difference between Colvera and carcinoembryonic antigen (CEA)?

Colvera is intended to detect the presence or absence of two methylated genes, BCAT1 and IKZF1, in small fragments of genetic material that leak from a tumor into the blood stream called circulating tumor DNA, that when present show a high concordance of colorectal cancer recurrence.

CEA immunoassays measure the amount of a protein that may appear in the blood of a CRC patient. Although CEA has been used for over three decades to monitor patients for cancer relapse and spreading, the test may yield false positive results that can be caused by smoking and other non-cancer conditions.

Head-to-head clinical evaluation in a recently published study showed that Colvera detected twice as many recurrent colorectal cancers as CEA.

Can Colvera be used as a screening test for colorectal cancer (CRC)?

Colvera is not intended for use in screening a general healthy population.  Currently, Colvera is only intended for use in patients known to have had CRC to aid in the early detection of recurrence or residual tumor. Colvera is intended for use in conjunction with other diagnostic tests and appropriate clinical follow up as part of a regularly scheduled surveillance program where it may be used to monitor those who have been previously treated with surgery and/or chemotherapy with curative intent.

Can Colvera be used for all colorectal cancer patients currently being monitored irrespective of what stage they have been treated for?

Published clinical data from a recent clinical study evaluating Colvera included patients who were being monitored for recurrence following treatment for primary colorectal cancer of all stages I through IV.

What is the level of detection for circulating tumor DNA (ctDNA) in the blood stream?

The Colvera test has a limit of detection (95% detection confidence) of 17.1 pg. methylated ctDNA per mL of plasma, which is equivalent to three genomic copies of cancer ctDNA per mL plasma.

Can blood be drawn in the physicians office?

Yes. Patients blood can be conveniently drawn in office during the time of their follow up appointment.

Do patients need to be fasting before having the test?

There is no need to change or modify your patients diet for testing.

What is the specimen type required for testing?

Colvera only requires two 9-10 mL tubes of whole blood.

How long does it take to receive the results?

Clinical Genomics’ Laboratory will provide results within 7-12 days.

How will Colvera results be reported?

For Positive Colvera Results:

POSITIVE (methylation in BCAT1 and/or IKZF1 gene)
A POSITIVE Colvera result indicates that methylation is detected at specific loci within either BCAT1 and/or IKZF1 and should be followed up consistent with suspected colorectal cancer recurrence, including radiological imaging as appropriate.

For Negative Colvera Results:

NEGATIVE (no methylation in either BCAT1 or IKZF1 gene)
A NEGATIVE Colvera result does not exclude the presence of cancer, and should be interpreted in conjunction with all clinical findings.

Is Colvera covered by insurance?

Clinical Genomics believes everyone should have access to the most innovative medical technology available, and we are committed to ensuring that Colvera is accessible and affordable. We accept all insurance plans and will bill on behalf of the patient. In addition, Clinical Genomics has a Financial Assistance Program with multiple payment plans available based on the patient’s financial situation. We are dedicated to excellence and are here to assist with any questions or concerns patients and family members may have.

To learn more about our patient-friendly Billing Policy and Assistance Programs please call 855-400-6919 or email billing@clinicalgenomics.com.

References:

  1. Young P., Womeldorph C, et al. Early detection of colorectal cancer recurrence in patients undergoing surgery with curative intent: Current status and challenges. Journal of Cancer 2014; 5 (4) 262-271.
  2. Nicholson BD, Shinkins B, Pathiraja I, Roberts NW, James TJ, Mallett S, Perera R, Primrose JN, Mant D. Blood CEA levels for detecting recurrent colorectal cancer. Cochrane Database of Systematic Reviews 2015, Issue 12. Art. No.: CD011134. DOI: 10.1002/14651858.CD011134.pub2.
  3. Young PE, Womeldorph CM, Johnson EK, et al. Early Detection of Colorectal Cancer Recurrence in Patients Undergoing Surgery with Curative Intent: Current Status and Challenges. Journal of Cancer. 2014;5(4):262-271. doi:10.7150/jca.7988.
  4. Young G., Pedersen S, Mansfield S, et al. A cross sectional study comparing a blood test for methylated BCAT1 and IKZF1 tumor-derived DNA with CEA for detection of recurrent colorectal cancer. Cancer Medicine 2016; 5(10):2763-2772.