In 2014, a diagnostic from the company Nanosphere was approved for the detection of CRE in cultured blood, in which the bacteria are present during acute infection. But scientists have continued to seek a test able to detect resistant CRE in the guts of people who have not progressed to a massive infection. This hope was fulfilled on 29 June when the FDA approved the Xpert Carba-R test, a rectal-swab diagnostic from the California-based company Cepheid that can detect carbapenem-resistant microbes in the gastrointestinal tract.
Unfortunately, honing a test to sense that an individual carries treatment-resistant strains of pathogens is not easy. “One of the common complaints we hear from diagnostics companies is that they don't have access to newly resistant strains of pathogens,” Ribhi Shawar, chief of the FDA's division of microbiology devices, told Nature Medicine. Access to such strains would enable companies to validate their diagnostic tools, he explains. For this reason, his team at the FDA and a group lead by Jean Patel, deputy director of the office of antimicrobial resistance at the CDC, are collaborating to establish a repository that houses isolates of drug-resistant pathogens so that researchers and companies developing diagnostics or novel antimicrobials can use the strains to test their products.
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