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The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.
The firm said that with the approval, the firm's liquid biopsy-based ExoDx Prostate IntelliScore (EPI) test is now available in every state.
The diagnostic can now be used to identify patients with head and neck squamous cell carcinoma who may benefit from first-line treatment with Keytruda.
The Columbia Solid Tumor Panel, a custom NGS panel from Pillar Biosciences, will be used at CUMC's Laboratory of Personalized Genomic Medicine.
The CD Diagnostics lateral flow test detects human alpha defensins proteins in the synovial fluid of patients with a total joint replacement in about 10 minutes.
The company will now be able to market the test, which algorithmically weighs molecular markers and clinical information, in all 50 US states.
The firm said it has multiple point-of-care tests available in Brazil and anticipates soon fulfilling an order for its dengue, chikungunya, and Zika tests.
With the approval of its ThyraMIR diagnostic assay, the firm said that physicians will have access to its thyroid product suite across several specimen types.
The diagnostic can now be used to identify a wider range of patients with stage III or metastatic NSCLC who may benefit from first-line treatment with Keytruda.
Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.