Nuclea Biotechnologies Inc. has filed premarket regulatory filings for FDA review on its Fatty Acid Synthase (FAS) and USP2a diagnostic assays in both breast and prostate cancer.
The premarket filings were submitted for review by FDA beginning in mid 2011 outlining the use of FAS as a monitoring tool in prostate cancer and in breast cancer.
“This is a major achievement for Nuclea and the way prostate cancer and breast cancer will be managed in the future,” said Patrick J. Muraca, president and CEO of Nuclea Biotechnologies. “Nuclea is committed to advancing these premarket filings forward with the highest clinical quality and setting new standards in personalized medicine for the management of disease.”
-Richard Park