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CE Marking for Novacyte's Real-Time PCR Kits for BK and Epstein Barr Virus

Novacyt have launched their next CE-Marked approved molecular products, the genesig® Real-Time PCR BK virus (BKV) Kit (CE) and genesig® Real-Time PCR Epstein-Barr Virus (EBV) Kit (CE).

These clinical products follow the launch of a Zika assay in the second half of 2017 and are the first of an expanding menu of molecular diagnostic tests for monitoring post-transplantation and immunosuppressed patients. The new molecular kits have been developed to provide quantitative detection of viral DNA extracted from blood plasma and urine (BKV kit), or blood plasma and whole blood (EBV kit) from immunocompromised patients.

The kits have been designed to run using the Roche LightCycler 480 PCR instrument. Novacyt believes there are over 2,000 LightCycler instruments installed worldwide and the availability of these kits will mean clinical labs running these PCR instruments will now be able to benefit from running these assays. Quantification standards in the kits are calibrated against the First World Health Organization International Standards for Virus Nucleic Acid Amplification Techniques (NIBSC code 14/212), producing strong levels of sensitivity and specificity performance as well as reproducibility.

The global transplant diagnostic and monitoring market is expected to grow at a compound annual growth rate (CAGR) of 10% due to a worldwide rise in the numbers of transplant procedures and is expected to be worth $1.0 Billion by 2022 (source: Allied Market Research Report Transplant Diagnostics Market). Certain pathogens have been associated with increased risk of organ rejection and physicians monitor patients to ensure that rejection risk is minimised. Another important posttransplant pathogen test is Cytomegalovirus (CMV) and Novacyt has already initiated development of a CMV assay to work alongside the BKV/EBV assays, which is targeted to be launched during 2019.



Date Published: 31st December 2018

Source article link: Microgen Bioproducts Ltd.

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