FDA ap­proves first quick test for MRSA/MSSA bac­te­ria

Modern Healthcare - - Late News -

The Food and Drug Ad­min­is­tra­tion cleared the first test able to quickly de­ter­mine whether Sta­phy­lo­coc­cus au­reus in­fec­tion bac­te­ria are me­thi­cillin re­sis­tant, known as MRSA, or me­thi­cillin sus­cep­ti­ble, known as MSSA, the agency an­nounced. Hos­pi­tal ex­ec­u­tives and reg­u­la­tors are work­ing hard to pre­vent health­careac­quired in­fec­tions, par­tic­u­larly those caused by MRSA be­cause of the dif­fi­culty and costs in treat­ing MRSA in­fec­tions. “Clear­ing this test gives health­care pro­fes­sion­als a test that can con­firm S. au­reus and then iden­tify whether the bac­te­ria is MRSA or MSSA,” Al­berto Gu­tier­rez, di­rec­tor of the Of­fice of In Vitro Di­ag­nos­tic De­vice Eval­u­a­tion and Safety in the FDA’s Cen­ter for De­vices and Ra­di­o­log­i­cal Health, said in a news re­lease. “This not only saves time in di­ag­nos­ing po­ten­tially life-threat­en­ing in­fec­tions but also al­lows health­care pro­fes­sion­als to op­ti­mize treat­ment and start ap­pro­pri­ate con­tact pre­cau­tions to pre­vent the spread of the or­gan­ism,” Gu­tier­rez said. The KeyPath MRSA/MSSA blood cul­ture test is man­u­fac­tured by Mi­croPhage of Long­mont, Colo., ac­cord­ing to the FDA.

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