The US FDA allows marketing of first test to aid in the diagnosis of a sexually-transmitted Mycoplasma genitalium.
M2 EQUITYBITES-January 24, 2019-The US FDA allows marketing of first test to aid in the diagnosis of a sexually-transmitted Mycoplasma genitalium
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Public health agency The US Food and Drug Administration Wednesday approved the marketing of the new Aptima Mycoplasma genitalium Assay test to aid in the diagnosis of a sexually-transmitted infection (STI), called Mycoplasma genitalium (M. gen.), which is associated with inflammation of the urethra (non-gonococcal urethritis) in men and inflammation of the cervix (cervicitis) and infection of the reproductive organs (pelvic inflammatory disease) in women.
The US FDA's marketing authorisation of the Aptima Mycoplasma genitalium Assay was awarded to Hologic Inc.
According to the agency, the Aptima Mycoplasma genitalium Assay is a nucleic acid amplification test, which detects M. gen. in urine, urethral, penile meatal, endocervical or vaginal swab samples. This is its first test for the M. gen. bacterium, a slow-growing bacterium that is difficult to detect via traditional methods.
In conjunction, the US FDA reviewed data from a clinical study that included testing of 11,774 samples. The study showed that the Aptima Mycoplasma genitalium Assay correctly identified M. gen. in 90% of vaginal, male urethral, male urine and penile samples. It correctly identified M. gen. in female urine and endocervical samples 77.8% of the time and 81.5% of the time, respectively. The test correctly identified samples that did not have M. gen. present 97.8% to 99.6% of the time.
Through the De Novo authorisation, the agency is establishing special controls for tests of this type, including requirements for demonstrating the accuracy and reliability of tests intended to be used as an aid in the diagnosis of M. gen. urogenital infections. The special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Jan 24, 2019|
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