Novacyt launches two new molecular diagnostic kits marked CE-IVD

Monday, Dec 24, 2018

Novacyt, an international specialist in clinical diagnostics, today announces the launch of its new CE-approved molecular products, the genesig® Real-Time PCR kit BKV (CE) and the kit genesig ® Real-Time PCR EBV (CE). These clinical products follow the launch of a Zika test in the second half of 2017 and are the first in a broader range of molecular diagnostic tests for the follow-up of patients in post-transplantation and immunocompromised patients.

The new molecular kits have been developed for the 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 work with Roche LightCycler 480 PCR instruments. Novacyt estimates that there are more than 2,000 LightCycler instruments installed worldwide and that the availability of these kits will mean that clinical laboratories using these PCR instruments will now be able to benefit from these tests. The quantification standards contained in the kits are calibrated according to the International Standards of the World Health Organization for the techniques of

The global market for transplant diagnosis and monitoring is expected to grow at a compound annual growth rate (CAGR) of 10% due to a worldwide increase in the number of transplants. This market would be estimated at one billion euros by 2022 (source: Allied Market Research Report Transplant Diagnostics Market). Some pathogens have been associated with an increased risk of organ rejection and physicians are monitoring patients to ensure that the risk of rejection is minimized. Another important post-transplant pathogen test is Cytomegalovirus (CMV) and Novacyt has already initiated the development of a CMV test to work in parallel with the BKV / EBV tests, which will be launched in 2019.



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