GeneProof announces expansion of its IVDR-certified PCR portfolio
3. 10. 2023
GeneProof, a leader in molecular diagnostics, today announced the addition of six new IVDR-certified PCR kits to its expansive portfolio.
This comes as a testament to the company’s dedication to delivering its entire portfolio of approximately 80 products as IVDR compliant by 2027. Currently, 27 products are IVDR cleared, with 16 that are Notified Body certified in class C and B. These include tests for infectious diseases and immuno-compromised/transplant.
The newly added IVDR kits focus on the diagnosis of sexually transmitted infections and include:
Multiplex CNMX: Designed for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium.
Duplex MGH: Designed for the detection of Mycoplasma genitalium/hominis.
Multiplex MUPX: Designed for the detection of Mycoplasma hominis, Ureaplasma urealyticum, and Ureaplasma parvum.
Singleplex Kits: Designed for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Chlamydia pneumoniae (CP), respectively.
GeneProof was among the first to obtain the EU Certificate for Quality Management System under the new Regulation (EU) 2017/746 IVDR. The company started its IVDR compliance journey early, positioning itself as one of the first European companies to operate in full adherence with the IVDR in January of 2023.
The extensive portfolio is built on its innovative “one workflow” technology. One workflow allows combining PCR kits from different diagnostic groups (including panels for respiratory infections and vector-borne diseases) in a single run for ease-of-use and compatibility with a wide range of qPCR instruments. GeneProof also offers a specialized panel for thrombotic mutations.
Additional IVDR certified kits will be available before the end of 2023.
Read more here.