Datar Cancer Genetics Unveils Exacta AI: A Revolutionary AI-Driven Cancer Treatment Platform

Metropolis Healthcare Partners with Roche to Launch Self-Sampling HPV DNA Test for Cervical Cancer Screening in India

Union Budget 2025: Full Exemption from Basic Customs Duty (BCD) for 36 Lifesaving Drugs

Dr. Jitendra Singh Inaugurates Centre for Advanced Genomics & Precision Medicine at AIIMS Jammu

Union Budget 2025-26: Key Healthcare Measures for Cancer Care and Access to Life-Saving Drugs

FDA Approves Roche’s PATHWAY HER2 Test for Identifying HER2-Ultralow Breast Cancer Patients Eligible for ENHERTU

Bristol Myers Squibb’s Breyanzi® Receives CHMP Recommendation for Relapsed or Refractory Follicular Lymphoma in the EU

NHS to Offer Groundbreaking Gene Therapy for Sickle Cell Disease

Quibim Secures $50M Series A to Advance AI-Powered Imaging for Precision Medicine

Apollo Hospitals Unveils Advanced Oncology Facility in Chennai

Beckman Coulter’s Alzheimer’s Blood Test Receives FDA Breakthrough Device Designation

ANGLE Announces Breakthrough Dual CTC-DNA and ctDNA Analysis with Illumina’s NGS Solution

Diatech Pharmacogenetics and Merck Expand Collaboration to Enhance RAS Biomarker Testing in MEA Region

DCG Unveils AI-Powered Video-Reporting for Personalized Chemotherapy Selection

FDA Approves Monthly Maintenance Dosing for LEQEMBI® in Alzheimer’s Treatment

Home
/
update
/
details

Thermo Fisher Scientific Receives FDA Clearance for Groundbreaking Neuroendocrine Cancer Assay

NextEdge Admin

20 Apr 2024

1 min 40 sec

Thermo Fisher Scientific has received FDA clearance for its innovative medical test, the BRAHMS CgA II KRYPTOR assay, marking a significant milestone in the field of oncology. This immunoassay is specifically designed for assessing tumor progression in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET). What sets this clearance apart is that it represents the FDA’s first approval of an immunoassay for this specific purpose, signifying a substantial advancement in the diagnosis and management of GEP-NET patients. Thermo Fisher’s BRAHMS CgA II KRYPTOR test enables laboratories and cancer centers to accurately measure the concentration of chromogranin A (CgA) in human serum. This capability empowers clinicians to closely monitor the progression of neuroendocrine tumors, allowing for more informed decisions regarding treatment effectiveness. The efficiency and precision of the BRAHMS CgA II KRYPTOR assay are enhanced by its compatibility with Thermo Scientific’s BRAHMS KRYPTOR Compact Plus random-access immunoassay analyzer. This state-of-the-art technology is capable of delivering highly accurate results in less than 30 minutes, streamlining the diagnostic process and expediting patient care.