"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.
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