COLVERA®

Information For Healthcare Professionals

Be COLVERA® Certain

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 Matters

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.

When To Use COLVERA®

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.

The COLVERA® Process

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.

Order COLVERA® with or without CEA. Blood draw in-office or at a Quest Patient Services Center.*

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.

Ship COLVERA® via FedEx or Quest Courier*

Ship COLVERA® via FedEx or Quest Courier*

*Shippers are available throughout the U.S. Courier service is only available to clinicians with a Quest Diagnostics account number.

​COLVERA® positive or negative results are provided within 10 days from receipt of specimen.

​COLVERA® positive or negative results are provided within 10 days from receipt of specimen.

A Financial Assistance Program for patients is available.

A Financial Assistance Program for patients is available.

FAQs

COLVERA® is a simple blood test that detects two methylated colorectal cancer genes, BCAT1 and IKZF1, associated with colorectal tumor growth in circulating tumor DNA.​

CEA measures the amount of a protein that may appear in the blood of a patient with colorectal cancer. Although CEA has been used for over three decades to monitor patients, the test is not positive in many patients with cancer and may yield false-positive results that can be caused by smoking and other non-cancer conditions.

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. (2,3)​

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 plasma. (4)​

HOW DO I START PROVIDING COLVERA® TESTS TO MY PATIENTS?
Blood can be drawn in the office or at a Quest Diagnostics® Patient Service Center (PSC) near your office.

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 RESULTS?
The Clinical Genomics Laboratory will provide results within 10 days.

HOW IS COLVERA® 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 "Not Detected" COLVERA® Results: NOT DETECTED (no methylation in either BCAT1 or IKZF1 gene) A NOT DETECTED COLVERA® result does not exclude the presence of cancer and should be interpreted in conjunction with all clinical findings.

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. Also, 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.​

References

(1) https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html

(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.

(3) 69_symonds_et_al_2019a.pdf

(4) http://jalm.aaccjnls.org/content/jalm/early/2017/07/25/jalm.2017.023135.full.pdf