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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.
The assay, which uses the Bioneer ExiStation molecular diagnostics instrument, was also recently registered for purchase by the Global Fund.
The assay is designed to detect ribosomal RNA from four clinically relevant Babesia species and runs on the company's Procleix Panther system.
The test uses multiplex PCR fragment analysis with Promega-designed five-mononucleotide repeat markers to detect the MSI-high phenotype within tumor tissues.
The test, for use on the Claros I Analyzer, leverages microfluidic technology in a disposable test cassette to provide results in 10 minutes or less.