Novacyt launches two new CE-marked molecular products

(Sharecast News) - Clinical diagnostics specialist Novacyt announced the launch of new CE-marked approved molecular products, the 'genesig' Real-Time PCR BK virus (BKV) kit and the 'genesig' Real-Time PCR Epstein-Barr Virus (EBV) kit.The AIM-traded company said the launch of the new clinical products followed the release of a Zika assay in the second half of 2017, and were the first of an "expanding menu" of molecular diagnostic tests for monitoring post-transplantation and immunosuppressed patients.It said the new molecular kits were 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 had been designed to run using the Roche LightCycler 480 PCR instrument.Novacyt said it believed there were more than 2,000 LightCycler instruments installed around the world, with the availability of those kits meaning clinical labs running the PCR instruments would now be able to benefit from running the new assays.Quantification standards in the kits were calibrated against the First World Health Organization International Standards for Virus Nucleic Acid Amplification Techniques, which the board said produced "strong levels" of sensitivity and specificity performance, as well as reproducibility.The global transplant diagnostic and monitoring market was expected to grow at a compound annual growth rate of 10%, due to a worldwide rise in the numbers of transplant procedures, and was expected to be worth $1bn by 2022.Certain pathogens had been associated with increased risk of organ rejection, and physicians monitored patients to ensure that rejection risk was minimised, Novacyt explained.Another important post-transplant pathogen test was Cytomegalovirus (CMV), with Novacyt having already initiated development of a CMV assay to work alongside the BKV/EBV assays, which was targeted to be launched during 2019."Investment in targeted research and development in our molecular diagnostics business is a key strategic growth driver for Novacyt and I am very pleased to announce the launch of these two new clinical diagnostic kits, which reinforce Novacyt's ability to develop CE-IVD products," said group chief executive officer Graham Mullis."We also look forward to expanding our pipeline in this fast-growing area to include a CMV test during 2019, further increasing our portfolio of CE-IVD tests."