BECAUSE THE TRUTH MATTERS.
COLVERA is a simple blood test that identifies the presence of two methylated genes, BCAT1 and IKZF1, in ctDNA, when present show a high concordance of colorectal cancer (CRC) 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.1
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.
“[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.”2
Challenges with current surveillance modalities
Currently, the standard blood test used to monitor colorectal cancer patients for recurrence is carcinoembryonic antigen (CEA). Although CEA has been used for over fifty years to monitor patients, the test may yield both false positive and false negative results.
CEA can yield false negative results in patients whose tumors may not secrete CEA, and false-positive results caused by smoking and other non-cancer related conditions, therefore making it essential to augment CEA with other diagnostic tests for recurrence surveillance.3
A 2014 study found that a rise in CEA fails to occur (false-negatives) in 30-50% of patients with a true recurrence, concluding that:
“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
In a head to head clinical evaluation, COLVERA detected
colorectal cancer recurrences compared to CEA
How COLVERA works
COLVERA identifies circulating fragments of tumor DNA (ctDNA) in blood using a sensitive PCR-based method to detect two genes (BCAT1/IKZF1) methylated (silenced) in colorectal cancer.
COLVERA does not depend on the presence of specific gene mutations, and is not affected by demographic features, smoking, or other non-cancerous conditions.
Why methylation matters
Methylation is an epigentic change associated with certain cancer development that occurs early, is persistent throughout the disease, and is readily identified. When genes are methylated, they are silenced, leading to unregulated cancer cell growth.
The methylation process is stable, allowing healthcare providers to monitor patients for residual and recurrent disease regardless of their tumor mutation profile; which are mainly used to select and guide therapy.
When to use COLVERA
COLVERA can be ordered with or without CEA for the detection of residual disease post-surgical resection, and for surveillance of recurrent colorectal cancer after primary treatment.
According to NCCN Guidelines Surgical Management of CRC Metastases, cure is possible for patients undergoing resection for colorectal liver metastases and should be the goal for a substantial number of these patients.4
Five year overall survival up to 71% post resection of liver metastases4
Testing patients with COLVERA is simple and designed to fit into the usual follow up schedule, with the added benefit of providing more information to you and your patients.
*For in-office blood draw, contact your local COLVERA representative for blood collection supplies.
*Shippers are available throughout the US. Courier service is only available to clinicians with a Quest Diagnostics account number.
Frequently asked questions
What is COLVERA?
How does COLVERA work?
What is the difference between COLVERA and carcinoembryonic antigen (CEA)?
Can COLVERA be used as a screening test for colorectal cancer (CRC)?
Can COLVERA be used for all colorectal cancer patients currently being monitored irrespective of what stage they have been treated for?
What is the level of detection for circulating tumor DNA (ctDNA) in the blood stream?
Can blood be drawn in the physicians office?
Do patients need to be fasting before having the test?
What is the specimen type required for testing?
How long does it take to receive the results?
How will COLVERA results be reported?
Is COLVERA covered by insurance?
- 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.
- 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.
- 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.
- NCCN Guidelines Version 2.2017 Colon Cancer. MS 21-22
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