Order COLVERA® with or without CEA. Blood draw in-office or at a Quest Patient Services Center.*
*For in-office blood draw, contact your local COLVERA® representative for blood collection supplies.
Every year there are approximately 140,000 newly diagnosed colorectal cancer cases in the United States. Following primary treatment, 30-50% of patients will see their cancer return, most of which will be within the first 2 – 3 years. (1)
Early detection of recurrent colorectal cancer may allow for additional treatment options and improved patient care. COLVERA® detects two methylated (silenced) genes, BCAT1 and IKZF1, associated with colorectal tumor tissue, in circulating tumor DNA, a technology that has demonstrated 2x greater sensitivity for colorectal cancer at detecting recurrent cancer than the current standard of care, CEA. COLVERA® does not depend on the presence of specific gene mutations and is not affected by demographic features, smoking, or other non-cancerous conditions —all of which have the potential to alter CEA levels.
COLVERA® can be added to a patient’s existing surveillance protocol to detect recurrences before confirmation of recurrence by imaging which may allow for different treatment options. A recently published study demonstrated improved sensitivity over CEA, and a PPV of 94.3% (2,3). In a cohort of 48 subjects with recurrence, COLVERA® was able to detect recurrence up to 11.6 months before the confirmation of recurrence, whereas no CEA test was positive more than 6 months before the confirmation of recurrence.
COLVERA® can also be used to evaluate the presence of residual disease following curative intent surgery. A recent study evaluating COLVERA® as a tool to measure completeness of surgical resection found that 74.5% of pre-surgically positive cases reverted to a negative COLVERA® after surgical resection. (4) A separate study showed that cases are five times more likely to be ctDNA positive after surgery when pathological features of residual disease are present, and post-surgery ctDNA positivity was independently associated with an increased risk of recurrence. (Murray et al.2018)
COLVERA® is a Laboratory Developed Test supplied by Clinical Genomics Pathology Inc. a CLIA Certified, CAP-accredited laboratory in Bridgewater, NJ, USA.
Methylation is an epigenetic change associated with certain cancer development that occurs early, is persistent throughout the disease, and is readily identified.
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® can be used to evaluate the presence of residual disease following curative intent surgery, or;
COLVERA® can be used with CEA for surveillance of recurrent colorectal cancer after primary treatment
By using COLVERA®, additional information will be provided that may help confidently manage patients and identify recurrent colorectal cancer before symptoms present.
COLVERA® is not intended for screening.
(2) 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.