Through this validation study, AMDL and Mayo Clinic will perform clinical diagnostic testing to compare AMDL’s DR-70 (FDP) cancer test with a newly developed, next generation test.
The primary goal of the study is to determine whether AMDL’s next generation DR-70 (FDP) test serves as a higher-performing test to its existing predicate test and can lead to improved accuracy in the detection of early-stage cancers.
For the FDA regulatory approval on the new test, AMDL intends to perform an additional study to demonstrate the safety and effectiveness of the next generation test for monitoring colorectal cancer. The validation study will run for three months and final results are expected in the second or third quarter of 2009.
Andrea Small-Howard, vice president of scientific oversight at AMDL, said: “These efforts will be a significant step in validating the efficacy of our next generation DR-70 test as a valuable tool for the monitoring of early stage cancers. Working through this critical and necessary phase in our product development process brings us one step closer to defining a leadership position in the cancer testing arena.”