Onko-Sure® Frequently Asked Questions
What is Onko-Sure?
Onko-Sure® is a cancer test cleared by the US FDA for monitoring the treatment and recurrence of colorectal cancer. It is the first such test cleared by the FDA since 1982, when Carcinoembryonic Antigen (also known as CEA) was approved. Compared to CEA, Onko-Sure is more sensitive at detecting lower levels of biomarker in colorectal cancer.
What does the Onko-Sure test detect?
Onko-Sure measures Fibrin and Fibrinogen Degraduation Products (FDP) in the blood. The FDP are over-produced in cancer patients.
Who can benefit from Onko-Sure?
Onko-Sure is recommended as a way for physicians to monitor the results of treatment they have prescribed for patients already diagnosed with Colorectal Cancer (CRC).
Can Onko-Sure diagnose cancer?
The Onko-Sure assay has been cleared by the US FDA solely for monitoring colorectal cancer treatment and recurrence. The assay has been cleared for expanded uses in other countries.
Does Onko-Sure detect other coagulation-related diseases?
Onko-Sure® has not been cleared in the US to be marketed for the detection of other coagulation-related diseases.
What are the advantages of Onko-Sure over CEA for colorectal monitoring?
CEA is not always an optimal blood test because the CEA molecule is firmly attached to cancer cells, whereas Onko-Sure is freely diffusible in the blood.
In addition, Onko-Sure is more sensitive in detecting lower levels of the tumor marker compared to CEA. That would enable the patient’s health care team to launch treatment at an earlier step, with potentially more effective outcomes. And finally, Onko-Sure is not affected by smoking, whereas CEA has been known to produce 20% false positives in smokers.
Are there advantages to combining Onko-Sure with CEA during treatment?
Certain studies would seem to indicate better results when the two are combined. For example, Shimwell et al from the UK published a paper in 2010 in “Cancer Biomarker” that showed that combining CEA and Onko-Sure® increased the sensitivity of the test. A collaborative study with Mayo Clinic in 2010 also showed that combining CEA and Onko-Sure® increased the sensitivity to 55% higher than that of CEA alone.
What if I have questions about Onko-Sure?
You can find additional information about Onko-Sure on this website, or you can email info@radient-pharma.com, or you can call 714-505-4406.