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regulatory approval

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.

The approval advances Chembio’s commercial agreement with Bio-Manguinhos to develop and supply rapid diagnostic tests for Zika, dengue, and chikungunya.

Based on PCR technology acquired from Hain Diagnostics, the test and platform enable rapid detection of TB, as well as assessment of antibiotic resistance.

The test can now be used to identify triple-negative breast cancer patients who are likely to benefit from the immunotherapy Tecentriq plus chemotherapy.

The PhosphorusOne test uses next-generation sequencing to analyze 375 genes covering 170 inherited conditions and 175 different drug reactions.

The kit is approved for the qualitative detection of BRCA1 and BRCA2 mutations in patients with different cancer types including breast cancer.

The test is for monitoring treatment response in chronic myeloid leukemia and uses a new Droplet Digital PCR instrument.

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