HER2/neu blood test, 1/14
January 2014—With the recent acquisition by Nuclea Biotechnologies of Wilex (Oncogene Science), Nuclea will begin its foray into the GMP manufacturing and marketing of the FDA 510(k)-cleared HER2/neu blood test out of its facility in Cambridge, Mass. The test is available as an in vitro diagnostic in the U.S., Canada, and Europe (CE mark).