NEW YORK – Bosch Healthcare Solutions said on Thursday that it has obtained a CE-IVD mark for its Vivalytic MG, MH, UP/UU test.
The multiplexed real-time PCR-based assay can detect four sexually transmitted infections involving Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma parvum, and Ureaplasma urealyticum.
The assay has a turnaround time of about an hour, and the company said it is positioning it for adoption at the point of care, such as in doctor's offices and clinics. Conventional approaches rely on culturing methods and can take up to days or even months to produce a result in the case of M. hominis.
Waiblingen, Germany-based Bosch, a subsidiary of the Bosch Group, has worked with Birmingham, Alabama-based BioGx to develop the test. The partners announced an agreement in 2020, under which BioGx would develop, produce, and supply reagents for Bosch's Vivalytic cartridges. BioGx also agreed to provide custom reagent manufacturing services for Vivalytic open system users at that time.