COLVERA®

Healthcare Professionals

About COLVERA

About COLVERA

Advancing Early CRC Recurrence Detection

When monitoring your patients after colorectal cancer (CRC) treatment, you want the most advanced detection and screening protocols. Through liquid biopsy, COLVERA detects two methylated (silenced) genes, BCAT1 and IKZF1, present in 95% of colorectal tumor tissues. By isolating and identifying these two circulating tumor DNA (ctDNA), COLVERA provides three times greater sensitivity than the carcinoembryonic antigen (CEA) testing that is currently used most often.

COLVERA is not affected by demographics, smoking, or other preexisting conditions. A COLVERA test can be added to standard CRC recurrence surveillance.

Methylation Matters

Methylation is an epigenetic change associated with certain cancer development that occurs early, is persistent throughout the disease, and is identified readily.

Epigenetic methylation can occur independently of somatic gene mutation, allowing healthcare providers to monitor patients for recurrent disease regardless of their tumor mutation profile.

COLVERA detects methylated BCAT and IKZF1 genes. These biomarkers are found in all stages of cancer (I-IV) and they capture tumor heterogeneity and evolution so there is no need for tissue profiling.

When to Use COLVERA

COLVERA can be added to existing patient monitoring protocols when:

COLVERA is not intended for screening.
  • The patient needs monitoring of residual disease.
  • Patient has been treated for primary or recurrent CRC within the previous five years
  • Patient is currently NED (no evidence of disease)
  • At least 3 months have passed since this patient’s most recent COLVERA test

Frequently Asked Questions

COLVERA is a blood test that detects two specific colorectal cancer biomarkers, BCAT1 and IKZF1, released in the blood from colorectal tumors. By identifying specific tumor DNA, instead of a protein, COLVERA has been three times more effective in detecting CRC early.

CEA is a test that has been used for over three decades to detect a specific protein present when colorectal cancer develops. However, CEA has caused false positives or does not detect CRC early enough for more treatments. There is a need for better testing.

Published clinical data from a recent clinical study evaluated COLVERA® for stages I through IV CRC patients1,2.

The COLVERA test has a limit of detection (95% detection confidence) of 12.6 pg of methylated ctDNA per mL of plasma, which is equivalent to two diploid genomic copies of cancer ctDNA per mL plasma3.

Do patients need to fast before having blood drawn?

There is no need to change or modify one’s diet for testing.

What is the specimen type required for testing?

COLVERA only requires two 10 mL tubes of whole blood.

How long does it take to receive my patient’s results?

The Clinical Genomics Laboratory will provide results within 10 business days from receipt of the specimen.

How is COLVERA reported?

COLVERA results are provided as ”Detected”, “Not Detected” or “Indeterminate”.

For Detected COLVERA Results: A detected COLVERA result indicates at least one replicate of IKZF1 or multiple replicates of either IKZF1 and/or BCAT1 are detected. Patient should be followed up consistent with suspected colorectal cancer recurrence, including radiological imaging as appropriate.

For Indeterminate COLVERA Results: An indeterminate COLVERA result indicates that only one replicate of BCAT1 is detected.

For "Not Detected" COLVERA Results: The test did not find any BCAT1 or IKZF replicates. A “Not Detected” or “Indeterminate” COLVERA result does not exclude the presence of cancer and should be interpreted in conjunction with all clinical findings.

1 Graeme P. Young, Susanne K. Pedersen, 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.
2 69_symonds_et_al_2019a.pdf
3 http://jalm.aaccjnls.org/content/jalm/early/2017/07/25/jalm.2017.023135.full.pdf

Additional Resources

Below are some helpful resources to share with your patients.

COLVERA Patient Brochure