What is Colvera?

Colvera™ is a clinically validated blood test intended to improve upon existing colorectal cancer (CRC) recurrence monitoring tests.  With Colvera, it may be possible to identify CRC recurrence in advance of symptoms, and before other tests indicate recurrence.

How Does Colvera Work?

During cancer growth and spreading, tumors may begin to release DNA into your bloodstream. These molecules are known as circulating tumor DNA (ctDNA).

Colvera is a qualitative test designed to help detect colorectal cancer recurrence by indicating the presence of two altered genes, BCAT1 and IKZF1, in ctDNA associated with colorectal tumor growth. By indicating the presence or absence of colorectal cancer, Colvera may help to provide more information about whether additional follow-up, such as radiological imaging, should be considered.

In a head to head clinical evaluation, Colvera detected

2x more

CRC recurrences compared to CEA

When to Use Colvera

Colvera is intended to be used after primary resection and therapy to monitor patients for recurrent colorectal cancer. Colvera is designed to fit into the usual monitoring schedule, and can be ordered and performed at the same time as CEA.

In a head to head 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 confirmed by CT Scan. Colvera detected recurrence in 19 of the 28 patients compared to only 9 of 28 patients detected by CEA.1

By using Colvera in combination with CEA, additional information will be provided that may help to more confidently monitor patients and possibly identify CRC recurrence before symptoms present and cancer has spread to other areas of the body. Colvera is not intended for screening at this time.

“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

References:

  1. 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.
  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.