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The FDA-cleared MALDI Biotyper CA System from Bruker identifies gram-negative bacterial colonies cultured from human specimens. The new system's accuracy has been shown to be comparable to nucleic acid sequencing.
FDA is scheduled to review Exact Science's Cologuard stool-based colorectal screening test in March. The company's pre-submission clinical trial was one of the largest colorectal screenings conducted in the United States.
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Genomic Health and the Almac Group are developing a multi-gene test that could improve screening of patients eligible for anthracycline-based chemotherapy regimens, currently one of the most common treatments available.
Molecular diagnostics company Biodesix announced that it has closed $8.4 million in Series E financing. The capital will help develop the company's mass-spec technology platform and market the company's first test, VeriStat, to guide NSCLC therapy.
Interference test kit components are available for individual sale or in customer-defined combinations, addressing the need of laboratories and manufacturers to simplify the evaluation of assays for common interferents.
Researchers at the Cedars-Sinai Medical Center have identified a 10-gene biomarker panel that may identify the aggressiveness of a patient's ovarian cancer, help predict survival outcomes, and result in novel therapeutic strategies.
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