FDA Approves First Automated Test for Neuroendocrine Tumour Progression
Sep 28 2023
Thermo Fisher Scientific, a global leader in scientific services, has received FDA clearance for the Thermo Scientific™ B·R·A·H·M·S™ CgA II KRYPTOR™ immunoassay, marking the first FDA-approved chromogranin A (CgA) test. It's also the only automated immunoassay globally designed for evaluating tumour progression in gastroenteropancreatic neuroendocrine tumour (GEP-NET) patients.
GEP-NETs originate from neuroendocrine cells, potentially developing in the pancreas or other gastrointestinal areas. While these tumours are categorised as rare diseases, data from the National Cancer Institute's Surveillance, Epidemiology, and End Results Program reveals a remarkable 500% increase in the disease's incident rate in the United States over the last thirty years.
This innovative test empowers laboratories and cancer centres to measure CgA concentration in human serum, offering valuable insights into tumour progression and treatment effectiveness evaluation. With FDA clearance, this assay becomes readily accessible for deployment in laboratories across the country, promising enhanced patient care and improved outcomes.
Tina Liedtky, President of Clinical Diagnostics at Thermo Fisher Scientific, commented: "Thermo Fisher is dedicated to developing clinical diagnostic solutions that empower healthcare providers to enhance patient outcomes. This assay allows customers to replace manual laboratory-developed tests, streamline lab workflows, and provides clear result interpretation."
The new assay is compatible with the Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS random-access immunoassay analyser, utilising TRACE™ technology, rooted in Nobel Prize-winning chemistry, to deliver highly precise results in less than 30 minutes.
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