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With an estimated 17 million cancer survivors in the US alone, the race is on to develop better technologies for identifying whether a cancer has begun to recur, and if so at what rate. There is a clear trend towards the use of immunoassays in cancer diagnostics, as immunotherapy for treatment. The AMAS test fits into these trends by measuring the level of a specific antibody, Anti-Malignin Antibody, which is thought to be produced by the body's immune system in response to nearly all forms of cancer.
Most other cancer immunoassays measure circulating levels of cancer antigens, which become elevated later than the antibody measured in the AMAS test. As a result, the AMAS Test is an excellent aid to picking up recurrence at an early stage, since levels of anti-malignin antibody are often elevated early in the occurrence and recurrence of cancer. This is a unique capability – false positive and false negative rates are under 10 percent. While the AMAS Test does provide guidance as to the likely location of the cancer, new high-resolution imaging techniques such as MRI and CT, as well as more location-specific cancer tests, as well as clinical signs can help the clinician provide patients with the larger context.
Currently, Oncolab provides the test via submission of samples to its CLIA-certified laboratory in Boston, MA. Serum samples must be shipped via overnight courier (FedEx, UPS or DHL) using a standardized shipping container and tubes provided at no cost by Oncolab, and dry ice obtained at the lab doing the blood draw and separation to serum. The test is permitted to market by FDA, and reimbursed by Medicare. Currently, the majority of samples being run are drawn in the US and Canada; overseas labs can also ship samples and are urged to contact Oncolab to get a technical and business relationship started.
The company is also working to develop a version of the test that can be run closer to the point of care; providers of new POC diagnostic platforms are encouraged to meet with the company's representatives at AACC to discuss possible development and deployment options.