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quandongboy

07/08/08 10:48 AM

#14808 RE: zolax #14807

This is from AMDL's company profile:

AMDL was founded in 1987 as a small bio-tech research and development firm that had one product, its proprietary cancer diagnostic test: AMDL-ELISA DR-70® (FDP).

It would be interesting to know when AMDL statrted the process of FDA approval & how long it took. It certainly didn't happen overnight and its unreasonable to expect it would happen overnight for bocx.

QB

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was Gyro

07/08/08 11:16 AM

#14809 RE: zolax #14807

This tells me something:

"Today's announcement marks the first clearance to market the FDA has granted for any monitoring product for CRC since January 14, 1982 when Carcinoembryonic Antigen (CEA) was approved. Until now, the CEA test has been the only accepted method cleared in the U.S. DR-70 (FDP) offers a new test that can monitor CRC tumors post-surgery."

The highlighted part above serves as a reminder that its easy to underestimate the difficulty in getting a test approved.

I like seeing the words "substantial equivalence" in the article. It gives a recent precedent for when BOCX makes their run at it.