Thermo Fisher Scientific Gets FDA Clearance for Neuroendocrine Cancer Assay

Original: 360DX

Thermo Fisher Scientific said on Wednesday that it has obtained US Food and Drug Administration clearance for its BRAHMS CgA II KRYPTOR test, a chromogranin A (CgA) immunoassay for assessing tumor progression in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients.

According to Thermo Fisher, the immunoassay is the first such test to be cleared by the FDA. The BRAHMS CgA II KRYPTOR assay was developed to help laboratories and cancer centers measure the concentration of CgA in human serum, allowing clinicians to track tumor progression while evaluating treatment success.

This assay is designed to run on Thermo Scientific’s BRAHMS KRYPTOR Compact Plus random-access immunoassay analyzer, which can deliver “highly accurate and precise results” in less than 30 minutes, the company said.

Source: Thermo Fisher Scientific Gets FDA Clearance for Neuroendocrine Cancer Assay