Skip to main content
Premium Trial:

Request an Annual Quote

Accelerate Diagnostics Submits Molecular, Phenotypic Detection Technologies for FDA Evaluation

NEW YORK (GenomeWeb) – Accelerate Diagnostics announced today that it has submitted a de novo request for evaluation of Automatic Class III Designation to the US Food and Drug Administration for its Accelerate Pheno system and Accelerate PhenoTest BC kit for positive blood culture samples. 

Accelerate Pheno and Accelerate PhenoTest BC use molecular and phenotypic detection technologies to identify pathogens from patient samples, and test them for antimicrobial susceptibility in a high-speed manner, the company said. It creates the potential to expedite optimal antimicrobial therapy for patients suspected of bacteremia or fungemia, which are both life-threatening conditions with high morbidity and mortality risk. The system and kit saved more than 40 hours compared to standard of care methods in recent marketing studies, the firm added.

Accelerate Diagnostics said that it anticipates launching the Accelerate PhenoTest BC kit with 140 individual assays. The final number of assays included in the kit distributed in the US will depend on the review of each individual assay for marketing authorization by the FDA.

The de novo request, sent Friday to the FDA, is supported by a recently completed clinical study including more than 1,800 samples across 13 study sites, the company noted. Overall results across all assays from the study showed 97.4 percent sensitivity and 99.3 percent specificity for pathogen identification results, and 95.1 percent essential agreement and 96.0 percent categorical agreement for antimicrobial susceptibility testing.

The Scan

Study Points to Tuberculosis Protection by Gaucher Disease Mutation

A mutation linked to Gaucher disease in the Ashkenazi Jewish population appears to boost Mycobacterium tuberculosis resistance in a zebrafish model of the lysosomal storage condition, a new PNAS study finds.

SpliceVault Portal Provides Look at RNA Splicing Changes Linked to Genetic Variants

The portal, described in Nature Genetics, houses variant-related messenger RNA splicing insights drawn from RNA sequencing data in nearly 335,700 samples — a set known as the 300K-RNA resource.

Automated Sequencing Pipeline Appears to Allow Rapid SARS-CoV-2 Lineage Detection in Nevada Study

Researchers in the Journal of Molecular Diagnostics describe and assess a Clear Labs Dx automated workflow, sequencing, and bioinformatic analysis method for quickly identifying SARS-CoV-2 lineages.

UK Team Presents Genetic, Epigenetic Sequencing Method

Using enzymatic DNA preparation steps, researchers in Nature Biotechnology develop a strategy for sequencing DNA, along with 5-methylcytosine and 5-hydroxymethylcytosine, on existing sequencers.