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BlackBio's BlackLight Sepsis Kit Garners CE Mark


Originally published Sept. 3.

BlackBio, a personalized medicine company based in Madrid, Spain, this week announced it has garnered CE Marking for its BlackLight Sepsis kit, a diagnostic test for the identification of infection-causing bacteria.

The universal bacteria testing kit identifies bacteria from patient samples via pyrosequencing, which allows for the identification of "any species of eubacteria including mycoplasma, without prior knowledge of the etiology of infection," BlackBio said in a statement, adding that the test is even valid for co-infection cases.

The kit identifies bacteria at the species and strain level by generating sequence data covering three regions of the 16S ribosomal gene. After the sequence data is compared to bacterial ribosomal databases provided alongside the kit, the results yield the most likely candidate organisms in the sample.

The company touted the fact that the sepsis diagnostic is faster than traditional methods of bacteria identification, taking less than four hours from bacterial colony selction to species identification. According to BlackBio the standard methods of determining these types of infections can often taken up to three days to receive test results, "which can result in ineffective treatment, bacterial resistance, and death."

According to BlackBio, several hospitals are already using the kit. Its accuracy has been tested with samples at hospitals, and it has shown the ability to recognize "not only common pathogens but rare and/or scarce ones," the company states on its website.

BlackBio launched in 2009, after spinning off of the European biotechnology firm Biotools B&M Labs Group. The company aims to develop diagnostic, pharmacogenomics, and personalized medicine tools in the area of metabolic disorders, oncology, and cardiovascular disease.

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