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2B BlackBio CE marks fungal infection test

This article was originally published in Clinica

Executive Summary

Spanish personalised medicine specialist 2B BlackBio has CE marked a fungal infection test, called the BlackLight Fungal ID Kit, for sale in Europe. The test uses microsequencing to identify Candida and Aspergillus, the fungal species responsible for around 95% of all invasive fungal diseases found in hospitals, which have a mortality rate of 30-40%. Accurate identification allows faster prescription of the most appropriate antifungal treatment, improving patient prognosis and survival, and minimising the risk of drug resistance, the Madrid-based firm says. The test takes less than four hours to carry out, which is faster than traditional methods such as culture in combination with serological or biochemical tests, which can take from several days to a month. The product is not currently approved in the US, and 2B BlackBio told Clinica that it intended to wait until it is well-established in the European market before trying to gain FDA approval.

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