BECAUSE THE TRUTH MATTERS.

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BECAUSE THE TRUTH MATTERS.

Why COLVERA?

COLVERA is a liquid biopsy 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

2x more

colorectal cancer recurrences compared to CEA

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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 epigenetic 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

Ordering COLVERA

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. Draw blood in-office or at a Quest Patient Service Center.*

*For in-office blood draw, contact your local COLVERA representative for blood collection supplies.

Ship COLVERA via FedEx or Quest Courier*

*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?

COLVERA is a blood test that helps healthcare providers detect colorectal cancer (CRC) recurrence. With COLVERA it may be possible to identify CRC recurrence  in advance of symptoms, and possibly before other tests indicate recurrence.

How does COLVERA work?

COLVERA is a qualitative test designed to help detect colorectal cancer (CRC) recurrence by indicating the presence or absence of two methylated or altered genes often associated with CRC, BCAT1 and IKZF1, in small fragments of genetic material that leak from a tumor into the blood stream called circulating tumor DNA or ctDNA. Methylation is a chemical change associated with cancer development, in circulating tumor DNA. Unlike DNA mutations, which are frequent in cancer, but may vary widely between patients and undergo mutation shifts during the course of disease, methylation is a chemical change associated with cancer development, in circulating tumor DNA that occurs early, is persistent and is readily measured. COLVERA is not intended to stratify the risk of recurrence in colorectal cancer patients, but rather to measure circulating tumor DNA at the time of testing. While COLVERA detects changes found in most recurrent tumors, COLVERA may not be positive in all patients. COLVERA does not identify DNA changes that may have been inherited from parents or passed on to children.

What is the difference between COLVERA and carcinoembryonic antigen (CEA)?

COLVERA is intended to detect the presence or absence of two methylated genes, BCAT1 and IKZF1, in small fragments of genetic material that leak from a tumor into the blood stream called circulating tumor DNA, that when present show a high concordance of colorectal cancer recurrence. CEA immunoassays measure the amount of a protein that may appear in the blood of a CRC patient. Although CEA has been used for over three decades to monitor patients for cancer relapse and spreading, the test may yield false positive results that can be caused by smoking and other non-cancer conditions. Head-to-head clinical evaluation in a recently published study showed that COLVERA detected twice as many recurrent colorectal cancers as CEA.

Can COLVERA be used as a screening test for colorectal cancer (CRC)?

COLVERA is not intended for use in screening a general healthy population.  Currently, COLVERA is only intended for use in patients known to have had CRC to aid in the early detection of recurrence or residual tumor. COLVERA is intended for use in conjunction with other diagnostic tests and appropriate clinical follow up as part of a regularly scheduled surveillance program where it may be used to monitor those who have been previously treated with surgery and/or chemotherapy with curative intent.

Can COLVERA be used for all colorectal cancer patients currently being monitored irrespective of what stage they have been treated for?

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.

What is the level of detection for circulating tumor DNA (ctDNA) in the blood stream?

The COLVERA test has a limit of detection (95% detection confidence) of 17.1 pg. methylated ctDNA per mL of plasma, which is equivalent to three genomic copies of cancer ctDNA per mL plasma.

Can blood be drawn in the physician's office?

Yes. Patients blood can be conveniently drawn in office during the time of their follow up appointment.

Do patients need to be fasting before having the test?

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

What is the specimen type required for testing?

COLVERA only requires two 9-10 mL tubes of whole blood.

How long does it take to receive the results?

The Clinical Genomics Laboratory will provide results within 7-12 days.

How will COLVERA results be 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 Negative Colvera Results: NEGATIVE (no methylation in either BCAT1 or IKZF1 gene) A NEGATIVE COLVERA result does not exclude the presence of cancer, and should be interpreted in conjunction with all clinical findings.

Is COLVERA covered by insurance?

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. In addition, 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.

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