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Pin to quick picksNovacyt Share News (NCYT)

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Novacyt launches two new CE-marked molecular products

Fri, 21st Dec 2018 14:31

(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."
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Novacyt taps Steve Gibson for CFO

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Novacyt facing delays in disposal of Yourgene Taiwan

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3 Jul 2023 09:07

Novacyt to buy Yourgene Health in £16.7m deal

(Sharecast News) - Yourgene Health surged on Monday after it agreed to be bought by Novacyt in a £16.7m deal.

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6 Dec 2022 12:29

UK regulator approves Novacyt Covid-19 test

(Sharecast News) - Shares in clinical diagnostics specialist Novacyt sparked on Tuesday, after the UK regulator approved its latest Covid-19 test.

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15 Jul 2022 08:43

Novacyt's exsig receives UK approval

(Sharecast News) - Clinical diagnostics group Novacyt's exsig Covid-19 Direct Real-Time PCR test has received approval from the UK's Health Security Agency.

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17 Feb 2022 15:38

Novacyt gets another Covid-19 test approved in the UK

(Sharecast News) - Clinical diagnostics company Novacyt announced on Thursday that its 'PROmate' Covid-19 2G Real-Time PCR test had been approved in the UK, under the UK Health Security Agency's coronavirus test device approvals (CTDA) regulations.

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26 Nov 2021 08:02

Novacyt gets UK approval for 'genesig' Covid-19 test

(Sharecast News) - Clinical diagnostics specialist Novacyt announced on Friday thatots 'genesig' Covid-19 real-time PCR test has been approved in the UK.

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2 Nov 2021 11:45

Novacyt flags possible £3m hit from Covid test regulations change

(Sharecast News) - Clinical diagnostics specialist Novacyt updated the market on the availability of its Covid-19 tests in the UK on Tuesday, following the implementation of amendments to the UK Health Security Agency's coronavirus test device regulations, or 'CTDA'.

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30 Sep 2021 09:37

Novacyt launches new 'Winterplex' test, lateral flow tests delayed

(Sharecast News) - Clinical diagnostics specialist Novacyt issued a research and development update on Thursday, including the launch of a new CE-marked 'Winterplex' polymerase chain reaction (PCR) test to diagnose Covid-19, respiratory syncytial virus (RSV) and types of influenza.

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27 Sep 2021 08:15

Novacyt swings to first-half loss amid DHSC dispute

(Sharecast News) - Clinical diagnostics specialist Novacyt reported group consolidated unaudited revenue of £54m in its first half on Monday, down from £63.3m year-on-year, which excluded £40.8m of Department of Health and Social Care (DHSC) revenues, while that contract dispute continued.

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16 Sep 2021 11:05

Novacyt FY revenues potentially 'materially affected' by outcome of DHSC dispute

(Sharecast News) - Biotechnology company Novacyt warned on first-half revenues on Thursday as a result of its ongoing dispute with the US Department of Health and Social Care.

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18 Aug 2021 10:12

First half revenues up more than 50pc for Novacyt

(Sharecast News) - Novacyt said in an update on Wednesday that unaudited revenue in its first half was ahead more than 50% year-on-year, at £94.7m.

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29 Jul 2021 15:31

Novacyt appoints David Allmond as new chief executive

(Sharecast News) - Clinical diagnostics specialist Novacyt announced the appointment of David Allmond as its new chief executive officer and a member of its board on Thursday, effective from 18 October.

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