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Accelerate Diagnostics Achieves ISO Certification

NEW YORK (GenomeWeb) – Accelerate Diagnostics today said that it has received ISO 13485:2003 certification. 

The company received certification for its quality management system and has started manufacturing and installing good manufacturing practice-compliant systems at select sites for a clinical trial in preparation of a submission to the US Food and Drug Administration for clearance of the Accelerate ID/AST System. The company also plans to seek FDA clearance for an associated test for positive blood cultures following the successful completion of the trial. 

The platform leverages Accelerate's proprietary technology for single-cell microbiology analysis. It uses a culture-free method for both genomic and phenotypic detection, and the system can perform molecular identification in one hour and provide antibiotic susceptibility testing results in five hours. In January, Accelerate CEO Lawrence Mehren told investors that the firm plans to launch the platform in Europe this year.

The Scan

Interfering With Invasive Mussels

The Chicago Tribune reports that researchers are studying whether RNA interference- or CRISPR-based approaches can combat invasive freshwater mussels.

Participation Analysis

A new study finds that women tend to participate less at scientific meetings but that some changes can lead to increased involvement, the Guardian reports.

Right Whales' Decline

A research study plans to use genetic analysis to gain insight into population decline among North American right whales, according to CBC.

Science Papers Tie Rare Mutations to Short Stature, Immunodeficiency; Present Single-Cell Transcriptomics Map

In Science this week: pair of mutations in one gene uncovered in brothers with short stature and immunodeficiency, and more.