Onko-Sure®, the AMDL-ELISA DR-70 (FDP) test, is the first new cancer test to be cleared by the US FDA for monitoring colorectal cancer (CRC) since Carcinoembryonic Antigen (CEA) was approved back in 1982. Onko-Sure® is between 12 and 100% more effective than CEA at detecting CRC recurrence in patients with low CEA values. Since greater than 50% of all stage CEA patients with biopsy-confirmed CRC have low CEA values, Onko-Sure® should add significant clinical value for monitoring CRC patients.
Strategic Advantages
• Simple, non-invasive blood test
• Standard Sandwich ELISA format
• Clinically-proven pan cancer marker
• New US FDA cleared cancer marker
• Tumor Marker 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)
• International regulatory approvals
• Multiple clinical uses
• International use as a cancer screen—verify type with other methods
FDA cleared in the US for colorectal cancer monitoring
Medical Usefulness of Onko-Sure®, The AMDL DR-70® (FDP) Test:
Clinical data supports the medical utility of Onko-Sure®, the AMDL-ELISA DR-70® (FDP) immunoassay, for the detection and monitoring of cancers in the ovaries, tongue, gastrointestinal tract, lung, breast, and colon/rectum. In the studies cited at the end of this document, Onko-Sure® was used to measure FDP levels in 7,999 patients. Within these studies, the Onko-Sure® results consistently correlated with either the positive detection or positive progression of a variety of cancers. A complete list of references follows.
Onko-Sure® Overview–How It Works:
While the production of Fibrin and Fibrinogen Degradation Products (FDP) is restricted in healthy individuals, FDP are over-produced by cancer cells which release proteolytic enzymes such as plasmin and thrombin. Current assays for FDP usually measure a specific FDP component, such as D-dimer, as a representative of this group; whereas the Onko-Sure® test detects the full complement of FDP. Onko-Sure® acts as a “barometer for cancer” by simultaneously measuring the multiple FDP species that may be underestimated by other tests.
Assay Description: Standard sandwich-type Enzyme-Linked ImmunoSorbent Assay (ELISA). 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.
Fig. 1. In a US-based CRC trial, Onko-Sure® showed increased positive concordance relative to CEA in CRC patients with low CEA values (<30) and equivalent positive concordance for patients with CEA values greater than 30. Negative concordance rates were also equivalent (data not shown). Greater than 50% of all stage CEA patients with biopsy-confirmed CRC have low CEA values; therefore, Onko-Sure® should add clinical value for monitoring CRC patients.
Onko-Sure® for CRC Treatment
For CRC survivors, effective monitoring for disease recurrence is perhaps the most important part of an effective post-surgery treatment plan. Onko-Sure® is the first new cancer test to be approved by the US FDA for the monitoring of CRC in decades. In early CRC stages (Duke’s stages A & B), between 68% and 97% of the biopsy positive patients have negative CEA values and are unable to be monitored with CEA.
Onko-Sure® is between 12 and 100% more effective than CEA at detecting CRC recurrence in patients with low CEA values. Greater than 50% of all stage CEA patients with biopsy-confirmed CRC have low CEA values; therefore, Onko-Sure should add significant clinical value for monitoring CRC patients.
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Onko-Sure®/DR-70® References:
1.Schaffrath, M et al. (2006) German J Obstetrics and Gynocology 66, 68-75.
2.Lee, K.H et al. (2006) Immune Network 6, 43-51.
3.Adonis, M et al. (2005) Toxicol Lett. 159:32-7.
4.Li, X. et al. (2005) Br J Oral Maxillofac Surg 43, 513-515.
5.Adonis, M et al. (2005) Xenobiotica 35:519-30.
6.Kerber, A. et al. (2004) Aliment Pharmacol Ther 20, 983-987.
7.Rucker, P et al. (2004) Analytical Letters 37, 2965-2976.
8.Wu, DF et al. (1999) Analytical Letters 32, 1351-1362.
9.Ding, L. et al. (1999) Chongqing Med J 28, 1-3.
10.Wu, D et al. (1998) J Immunoassay 19, 63-72