Novacyt S.A. Novacyt launches two new molecular diagnostic kits
21 Dezembro 2018 - 5:00AM
RNS Non-Regulatory
TIDMNCYT
Novacyt S.A.
21 December 2018
Novacyt launches two new CE-IVD Marked
molecular diagnostic kits
First of an expanding menu of tests for monitoring
post-transplantation and immunosuppressed patients
Paris, France and Camberley, UK - 21 December 2018 - Novacyt
(EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in
clinical diagnostics, today announces the launch of its next
CE-Marked approved molecular products, the genesig(R) Real-Time PCR
BK virus (BKV) Kit (CE) and genesig(R) 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 post-transplant 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.
Background to BKV
BKV is a polyomavirus and which can cause disease in humans. BKV
primary infection usually occurs in childhood leading to symptoms
similar to a common cold followed by lifelong latent infection. BKV
causes disease during transplantation, including BKV-associated
nephropathy in kidney transplantation, which leads to renal injury
and graft loss. BKV also leads to haemorrhagic cystitis in
hematopoietic cell transplantation.
Background to EBV
EBV is a gamma herpesvirus, and like BKV can cause disease in
humans. EBV primary infection usually occurs in childhood leading
to asymptomatic viremia followed by lifelong latent infection,
while later infection can lead to mononucleosis. EBV has oncogenic
potential and is associated with a range of cancers, including
Post-Transplant Lymphoproliferative disorder in post-transplant
recipients.
To prevent diseases caused by both BKV and EBV, there is
increasing demand for monitoring DNAemia after transplantation and
in patients undergoing immunosuppression.
Graham Mullis, Group CEO of Novacyt, commented:
"Investment in targeted R&D 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.
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."
- End -
Contacts
Novacyt SA
Graham Mullis, Chief Executive Officer
Anthony Dyer, Chief Financial Officer
+44 (0)1223 395472
Stifel Nicolaus Europe Limited (Nominated Advisor and Joint
Broker)
Jonathan Senior / Fred Walsh / Ben Maddison
+44 (0)20 7610 7600
WG Partners (Joint Broker)
Nigel Birks / Chris Lee / Claes Spång
+44 (0) 203 705 9330
FTI Consulting (International)
Brett Pollard / Victoria Foster Mitchell
+44 (0)20 3727 1000
brett.pollard@fticonsulting.com /
victoria.fostermitchell@fticonsulting.com
FTI Consulting (France)
Arnaud de Cheffontaines / Astrid Villette
+33 (0)147 03 69 47 / +33 (0)147 03 69 51
arnaud.decheffontaines@fticonsulting.com /
astrid.villette@fticonsulting.com
About Novacyt Group
The Novacyt Group is a rapidly growing, international
diagnostics group with a growing portfolio of cancer and infectious
disease products and services. Through its proprietary technology
platform, NOVAPrep(R), and molecular platform, genesig(R), Novacyt
is able to provide an extensive range of oncology and infectious
disease diagnostic products across an extensive international
distributor network. The Group has diversified sales from
diagnostic reagents used in oncology, microbiology, haematology and
serology markets, and its global customers and partners include
major corporates.
For more information please refer to the website:
www.novacyt.com
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END
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