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TEST:
MEBGEN™ BRAF 3 Kit

Type:
Other Approval
Related tests:
Evidence

News

8ms
Concordance of BRAF V600E mutation between immunohistochemistry and genomic testing for thyroid cancer. (PubMed, Int J Clin Oncol)
Concordance between IHC and genomic testing in assessing BRAF V600E was encouragingly high; its reliability and potentially short TAT should benefit patients, especially those with ATC.
Journal
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BRAF (B-raf proto-oncogene)
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BRAF V600E • BRAF V600
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FoundationOne® CDx • Oncomine™ Dx Target Test • MEBGEN™ BRAF 3 Kit • MEBGEN™ BRAF Kit
2years
MEBGEN™ BRAF 3 Kit receives MHLW approval and insurance coverage as a tumor agnostic companion diagnostic (JSR Life Sciences Press Release)
"Medical and Biological Laboratories Co., Ltd...a JSR Life Sciences Company, announced that the MEBGEN™ BRAF 3 Kit, an in vitro diagnostic reagent, was approved for manufacturing and marketing by the Ministry of Health, Labour and Welfare (MHLW) on August 18, 2023, and received national health insurance coverage on November 1, 2023...With MHLW approval and insurance coverage, the MEBGEN™ BRAF 3 Kit is expected to support personalized medicine based on its ability to detect the presence or absence of BRAF gene mutations in rare tumors (solid tumors including histiocytosis and hairy cell leukemia) for which treatment options are limited."
Reimbursement • Japanese regulatory
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MEBGEN™ BRAF 3 Kit