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Prodesse Files for FDA OK for C. Difficile Assay

NEW YORK (GenomeWeb News) – Prodesse today said that it had filed for US Food and Drug Administration clearance of its molecular diagnostics assay for Clostridium difficle.

The Milwaukee, Wis.-based firm said that it had filed for 510(k) clearance of the ProGastro Cd Assay following clinical trials conducted at several clinical labs in the US. The assay is already being used for clinical diagnostics in Europe, and additional studies of the test are currently being conducted in the UK.

Prodesse Quality Officer Kristine Schraufnagel said that clinical trials on the ProGastro Cd Assay "easily met our clinical goals for sensitivity and specificity." The test provides results in as few as three hours, the firm said.

Prodesse also said that it has completed clinical trials on its ProParaFlu Assay and expects to submit a 510(k) filing with the FDA within the next 120 days.

The Scan

Wolf Howl Responses Offer Look at Vocal Behavior-Related Selection in Dogs

In dozens of domestic dogs listening to wolf vocalizations, researchers in Communication Biology see responses varying with age, sex, reproductive status, and a breed's evolutionary distance from wolves.

Facial Imaging-Based Genetic Diagnoses Appears to Get Boost With Three-Dimensional Approach

With data for more than 1,900 individuals affected by a range of genetic conditions, researchers compared facial phenotype-based diagnoses informed by 2D or 3D images in the European Journal of Human Genetics.

Survey Suggests Multigene Cancer Panel VUS Reporting May Vary Across Genetic Counselors

Investigators surveyed dozens of genetic counselors working in clinical or laboratory settings, uncovering attitudes around VUS reporting after multigene cancer panel testing in the Journal of Genetic Counseling.

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.