December 4, 2018 (Branford, CT) – Tangen Biosciences, Inc., submitting a Pre-Submission for the Tangen Bacillus anthracis BSI Assay Kit to the FDA.
Tangen Biosciences, Inc. filed a Pre-Submission package to the FDA for the Tangen Bacillus anthracis BSI Assay Kit for the detection of B. anthracis in blood. The Assay Kit is intended for use in the qualitative in vitro diagnostic (IVD) detection and identification of target DNA sequences on the pXO1 plasmid (Target 1) and the pXO2 plasmid (Target 2) from B. anthracis in human whole blood.
The Assay was developed pursuant to a contract between Tangen Biosciences, Inc. (Tangen) and the Biomedical Advanced Research and development Authority (BARDA). This contract was awarded to Tangen by BARDA to further advance and expand the ability to combat the threat of B. anthracis. The Tangen Bacillus anthracis BSI Assay Kit is a rapidly deployable assay intended to be run on the TangenDx Instrument. The Instrument is a hand-sized platform that can be battery or line operated and provide answers within one hour. The assay is a rapid, direct-from-blood process that eliminates the need for blood culture. The DNA is extracted and delivered to the amplification reaction in 5 minutes using the Tangen Blood Processing Unit, thus avoiding the need for extended nucleic acid extraction and purification.
The Pre-Submission is designed to obtain the FDA’s feedback regarding the proposed intended use and indications for use, choice of predicate device, the analytical plan, and the clinical study design. The feedback will be integrated into the upcoming Tangen B. anthracis BSI Assay Kit clinical study protocol. The results of the clinical study will be a component of the 510(k) submission to the FDA for clearance.