Molecular diagnostics company Mobidiag has secured CE-IVD mark approval for its Novodiag Stool Parasites test.
The company has developed the new Novodiag molecular diagnostic test to detect intestinal parasites directly from stool samples.
The comprehensive test combines real-time PCR and microarray technologies to facilitate quick detection of >95% of intestinal parasites.
Novodiag Stool Parasites detects presence of nucleic acid markers
The syndromic test, which is designed to run on-demand using the automated Novodiag system, can detect the presence of nucleic acid markers corresponding to the identification of the common protozoan, helminths, and microsporidia from stool samples.
Part of the Novodiag platform, the Novodiag Stool Parasites is an automated qualitative nucleic acid-based diagnostic test that offers complete results within 90 minutes and less than five minutes hands-on time by an operator.
Novodiag platform enables direct analysis of a patient sample placed in a disposable cartridge for comprehensive screening of multiple or single pathogens.
Mobidiag also offers Novodiag C. difficile, Novodiag Bacterial GE+ and Novodiag CarbaR+ tests, in addition to the new Novodiag Stool Parasites test.
Mobidiag CEO Tuomas Tenkanen said: “Parasitic diseases contribute significantly to the burden of infectious diseases worldwide and current diagnostic methods such as microscopy are labor-intensive and require a high level of skill.
“Our Novodiag® Stool Parasites test is the only fully automated, rapid, cost-effective and easy to use diagnostic solution that can identify a comprehensive range of parasitic targets, for use in laboratories and hospitals.”
In June this year, Mobidiag partnered with China-based clinical diagnostics company Autobio Diagnostics to launch the joint venture (JV) Automobi Molecular Diagnostics.
Automobi has been established to commercialise the Novodiag platform and infectious disease assays in the Greater China territory.
In July, Mobidiag signed an exclusive agreement with Pro Med Diagnostics to distribute its Amplidiag and Novodiag products in African countries including South Africa, Namibia, Botswana, Zimbabwe, Swaziland, Lesotho, Malawi, Kenya and Uganda.
