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FDA Expands Clearance for Agendia's MammaPrint

NEW YORK (GenomeWeb News) – Agendia today said that the US Food and Drug Administration has cleared its MammaPrint breast cancer recurrence test for all ages.

Amsterdam-based Agendia said that it is the fourth FDA clearance for MammaPrint over the past three years. It also noted that MammaPrint has been approved in Europe for all ages since 2004.

"This FDA clearance, along with our recently obtained CMS coverage for all stage I and II breast cancer patients, including patients with up to three positive lymph nodes, will facilitate our discussions with healthcare providers about patients' eligibility criteria for MammaPrint," Agendia CEO Bernhard Sixt said in a statement.

The Scan

Genome Sequences Reveal Range Mutations in Induced Pluripotent Stem Cells

Researchers in Nature Genetics detect somatic mutation variation across iPSCs generated from blood or skin fibroblast cell sources, along with selection for BCOR gene mutations.

Researchers Reprogram Plant Roots With Synthetic Genetic Circuit Strategy

Root gene expression was altered with the help of genetic circuits built around a series of synthetic transcriptional regulators in the Nicotiana benthamiana plant in a Science paper.

Infectious Disease Tracking Study Compares Genome Sequencing Approaches

Researchers in BMC Genomics see advantages for capture-based Illumina sequencing and amplicon-based sequencing on the Nanopore instrument, depending on the situation or samples available.

LINE-1 Linked to Premature Aging Conditions

Researchers report in Science Translational Medicine that the accumulation of LINE-1 RNA contributes to premature aging conditions and that symptoms can be improved by targeting them.