Overview: Physicians and Onko-Sure®
AMDL-ELISA DR-70 (FDP) (branded as Onko-Sure®) Assay
The AMDL-ELISA DR-70 (FDP) test is the most recent cancer test cleared by FDA for monitoring of treatment and recurrence of colorectal cancer and is branded as Onko-Sure®.
Strategic Advantages
- 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.
Sensitivity Test
Table 1. Effectiveness of DR-70 (Onko-Sure®) in Colorectal Cancer
| Effectiveness | |||
| Type of Cancer | Sensitivity(%) | Specificity(%) | No. of Studies |
| Colorectal Cancer | 54-87 | 67-95 | 7 |