Posted by Michael Wonder on 14 May 2021
Molzym announces FDA breakthrough device designation for its molecular diagnostic test system – sepsis, ioint & implant infections, infective endocarditis, bacterial meningitis
10 May 2021 - Molzym’s unique technology for molecular microbial diagnostics was granted breakthrough device designation by the FDA in light of its capacity to aid the diagnosis of bloodstream infection/sepsis, joint and implant infections, infective endocarditis and bacterial meningitis as an adjunct to the current standard of care.
MMDx utilizes specific enrichment and extraction processes of microbial DNA directly from samples, DNA free reagents and consumables (including Universal 16S and 18S PCR assays) that detect the presence of bacteria and fungi.
Positive PCR results are processed through Sanger Sequencing to identify the specific microorganisms and assist physicians with applicable clinical care pathway decisions - total time to result is 7 hours.
