Monitoring

COLVERA®

If you have been treated for colorectal cancer, and you are being monitored afterward, our COLVERA® blood test can alert you and your doctor of possible recurrence.

Be COLVERA Certain.

Overview

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 growth in circulating tumor DNA, a technology that has greater sensitivity for colorectal cancer than measuring for CEA, the current standard of care.

In recent studies, COLVERA® detected twice the number of recurrent cases compared to CEA and can detect colorectal cancer recurrence up to 5 months earlier than CEA with a positive predictive value of 94%. (2, 3)

COLVERA® is a Laboratory Developed Test supplied by Clinical Genomics Pathology Inc. a CLIA Certified, CAP-accredited laboratory in Bridgewater, NJ, USA.

In a head to head clinical evaluation, COLVERA detected 2x more colrectal cancer recurrences compared to CEA

When To Use COLVERA®

COLVERA^® can be used with CEA for surveillance of recurrent colorectal cancer after primary treatment

By using COLVERA^® in combination with CEA, additional information will be provided that may help confidently manage patients and identify recurrent colorectal cancer before symptoms present.

In addition to detecting recurrences, data is showing promising utility of COLVERA^® to evaluate residual disease (MRD) in patients who have had their cancer surgically removed. A recently published study found that 74.5% of the cases who were ctDNA positive prior to surgery became negative after resection and concluded “The presence of ctDNA in blood is stage-related and shows rapid reversion to negative following surgical resection. Monitoring methylated BCAT1 and IKZF1 levels could therefore inform adequacy of 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 not intended for screening.

^{(1) Kim et al, Ann Coloproctol 2013}

^{(2) Shah et al, JCO 2016}

^{(3) Moertal et al, JAMA 1993}

^{(4) Pugh et al, Ann Surg 2016}

^{(5) NCCN Clin Practice Guidelines 2019}

^{(6) Meyerhardt et al, JCO 2013}

Patients

Healthcare Professionals

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