Nuclea device obtains federal classification
Nuclea Biotechnologies Inc., which has operations in Worcester, announced that federal regulators have classified its cell metabolism measurement device as having low to moderate risk.
The U.S. Food and Drug Administration has listed Nuclea’s Fatty Acid Synthase (FAS) Immunohistochemistry (IHC) Kit as a Class I device, meaning it’s subject to facility registration and Good Manufacturing Practice regulations.
By measuring the metabolism of cells in both oncology and metabolic diseases, Nuclea said FAS IHC results can help physicians better design and optimize treatment strategies for patients.
The kit was manufacturing in Nuclea’s Cambridge facility and uses a proprietary antibody to measure FAS in tissue samples with excellent reproducibility and performance, the company said. It will be available as a test in Nuclea’s Pittsfield laboratory in the near future, according to the company.
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