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Mediven Garners CE Mark for Leptospirosis MDx

NEW YORK (GenomeWeb) – Malaysia-based diagnostics firm Medical Innovation Ventures, also known as Mediven, has garnered CE marking for a PCR kit to detect different serovars of leptospira, the spirochete bacteria that causes leptospirosis.

Leptospirosis is a leading zoonotic cause of morbidity and mortality that is transmitted by contact with animal urine or urine-contaminated water. Infection typically results in a mild disease — however, an estimated 59,000 of the 1.5 million cases globally per year prove fatal, and more than 40 percent of deaths occur in males between the ages of 20 and 49.

The bacteria has about 250 pathogenic serovars. Mediven's GenoAmp Real Time PCR Leptospirosis kit detects 15 of the most common serovars recommended for diagnostic testing by the World Health Organization, the firm noted in a statement.

Diagnosis often relies on immunoassays in a post-acute phase, but molecular tests can detect the illness earlier. "The infection is often incorrectly diagnosed due to the nonspecific symptoms, and the fact that most kits test for antibodies ... makes early detection of the test problematic," Mediven Executive Director Ariff Ismail said in a statement.

The Mediven test takes about three hours to run and is intended for rapid and early diagnosis in clinical samples such as blood and urine, as well as for use in environmental surveillance. The kit has also been clinically validated and chosen as the preferred molecular assay for the screening of leptospirosis in several public health labs and hospitals in Southeast Asia, Ismail noted.