Nuclea cancer kit obtains FDA status
Nuclea Biotechnologies, Inc., based in Pittsfield but with operations in Worcester, has announced that a kit using Carbonic Anhydrase IX has been classified by the Food and Drug Administration (FDA) as a Class I in vitro diagnostic (IVD) device for use on a Ventana Benchmark XT instrument.
The classification will allow the device to be used to help in the analysis of a variety of cancers. The kit uses a proprietary antibody to measure Carbonic Anhydrase IX in tissue samples. A benefit of obtaining Carbonic Anhydrase IX results includes providing physicians with additional data that can be utilized in conjunction with other clinical information to design and optimize personalized treatment strategies for patients.
“We’re excited to include Carbonic Anhydrase IX as a part of the menu of tests that Nuclea offers,” said Mary Lopez, COO and VP of Proteomic Discovery at Nuclea Biotechnologies. “Carbonic Anhydrase IX has become an important marker for various cancers and the Carbonic Anhydrase IX IHC test is quite unique.”
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