Overview: Onko-Sure And Laboratories
AMDL-ELISA DR-70 (FDP) (branded as Onko-Sure®) Assay
The AMDL-ELISA DR-70 (FDP) test has been cleared by the FDA for post-diagnosis monitoring of CRC patients in order to guide treatment and to reduce recurrence. The product is marketed under the brand name Onko-Sure(R), and is available from Radient Pharmaceutical.
What Specifically is Onko-Sure and How Does It Work?
Here are the details in a nutshell:
- It’s a simple, non-invasive blood test
- Standard Sandwich ELISA format
- Clinically proven in 12 published studies for monitoring of colorectal cancer treatment and recurrence
- The blood biomarker is abundant in serum
- Floats-freely in blood (unlike CEA)
- Levels rise dramatically with cancer progression (up to 38 times greater than in normal patients)
Onko-Sure® Assay Description
Standard sandwich-type Enzyme-Linked ImmunoSorbent Assay (ELISA). The antigen is captured from human serum samples by an affinity-purified rabbit anti-DR-70® (FDP) antibody that is immobilized in the wells of a standard 96-well assay plate. After appropriate washing, the antigen captured from the serum sample is complexed by a peroxidase-labeled detection antibody to form an immuno-sandwich. The bound enzyme conjugate is quantitatively measured with TMB substrate. Immediately after stopping the enzymatic reaction, the absorbance of the solution is read at 450 nm.