Onko-Sure® Proposed Mechanism of Action in Patients with Colorectal Cancer
Onko-Sure® is a simple, non-invasive in vitro blood test cleared by the FDA for use in post-operative monitoring of Colorectal Cancer (CRC) treatment and recurrence. It is an ELISA-based assay that measures the accumulation of fibrin/Fibrinogen Degradation Products (FDP) in the serum using a polyclonal antibody against the DR-70 blood biomarker.
Onko-Sure is also being used in Canada for the detection of lung cancers, and in many other countries for detection and monitoring of approximately 19 other cancers.
In the US, Onko-Sure® is helping physicians monitor post-operative CRC patients to assess both the success of prescribed treatment and to potentially spot the recurrence of the cancer as early as possible. CEA, commonly used to spot recurrence in later stages, can be used effectively in combination with Onko-Sure® to ascertain a more complete picture of post-diagnostic patient health. Because it measures a blood biomarker that floats freely in the blood (not attached to the cells), Onko-Sure® is sensitive to a lower concentration of the marker and fills in information that, CEA does not.
Approximately 35% of CRC patients develope recurrence. Of those, 50% have low CEA values not detectable by the CEA test. Onko-Sure® provides data that CEA cannot, earlier in the recurrence process, In other words, Onko-Sure® puts time back on the side of patients.
Another advantage: Onko-Sure® works well with patients who smoke, whereas CEA alone does not.
Onko-Sure® combined with CEA gives CRC patients a 55% higher sensitivity advantage that can lead to earlier detection of recurrence, more timely treatment, and better survival rates.
DOCUMENTS:
List of Patient Selection Criteria
Onko-Sure® Assay Description
Onko-Sure® Mechanism of Action US
Summary Table Colorectal Cancer Sensitivity
Download Physicians Information Sheet on Onko-Sure®