Novacyt S.A.
("Novacyt", the "Company" or the
"Group")
IVDR accreditation for
Yourgene® QST*R Base
assay
Paris, France, and Manchester, UK - 20
February 2025 - Novacyt (EURONEXT GROWTH: ALNOV; AIM:
NCYT), an
international molecular diagnostics company with a broad portfolio
of integrated technologies and services, announces that it has
received accreditation under the new EU requirements
of the In Vitro Diagnostic Regulation ("IVDR")
for the Yourgene® QST*R Base assay. The Yourgene® QST*R Base
is a Class
C in
vitro medical device
under IVDR and is intended for use by healthcare professionals
within a molecular laboratory environment.
Yourgene® QST*R Base is a highly multiplexed,
single tube assay containing 22 markers for rapid diagnosis of the
common autosomal and sex chromosome aneuploidies during
pregnancy. For those women identified as being at high risk of
carrying a fetus with one of these conditions, chorionic villus
sampling (10-12 weeks) or amniocentesis (14-18 weeks) is offered
and QST*R Base would then
be used by the laboratory. Autosomal markers are used to detect the
three most common viable autosomal trisomies: trisomy 21 (Down's
syndrome), trisomy 18 (Edwards' syndrome) and trisomy 13 (Patau's
syndrome). The chosen markers are highly informative with results
obtained in >99% of samples.
IVDR ensures that the Yourgene®
QST*R Base assay, which is
manufactured for sale in the EU, is assessed against stringent
quality, safety and performance requirements. Manufacturers must
provide considerable evidence of scientific validity, as well as
data demonstrating analytical and clinical performance of the
tests. The Yourgene® QST*R Base assay was assessed by British
Standards Institution (BSI), an independent conformity assessment
body, and was shown to conform to the new regulations.
Lyn
Rees, CEO of Novacyt, commented: "This is the third IVDR
accreditation for Novacyt which further demonstrates the high
quality and accuracy of our products, and our team's ability to
navigate the stringent new regulatory environment for in
vitro diagnostic tests.
Novacyt has a range of tests for the reproductive health lifecycle
and the QST*R Base test is complementary to our NIPT tests
providing a follow-on confirmatory test after a high risk NIPT
result. We are very proud to have developed an
assay that
provides accurate and reliable
results during a stressful time in the pregnancy for expecting
parents."
Contacts
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Novacyt SA
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https://novacyt.com/investors
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Lyn Rees, Chief Executive
Officer
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Via Walbrook
PR
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Steve Gibson, Chief Financial
Officer
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SP
Angel Corporate Finance LLP (Nominated Adviser and
Broker)
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+44 (0)20
3470 0470
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Matthew Johnson / Charlie Bouverat
(Corporate Finance)
Vadim Alexandre / Rob Rees
(Corporate Broking)
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Deutsche Numis (Joint
Broker)
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+44 (0)20
7260 1000
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Freddie Barnfield / Duncan Monteith
/ Michael Palser
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Allegra Finance (French Listing Sponsor)
Rémi Durgetto / Yannick
Petit
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+33 (1) 42 22 10 10
r.durgetto@allegrafinance.com
/ y.petit@allegrafinance.com
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Walbrook PR (Financial PR & IR)
Paul McManus / Lianne
Applegarth
Phillip Marriage / Alice
Woodings
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+44 (0)20
7933 8780 or novacyt@walbrookpr.com
+44
(0)7980 541 893 / +44 (0)7584 391 303
+44
(0)7867 984 082 / +44 (0)7407 804 654
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About Novacyt Group (www.novacyt.com)
Novacyt is an international
molecular diagnostics company providing a broad portfolio of
integrated technologies and services, primarily focused on the
delivery of genomic medicine. The
Company develops, manufactures, and
commercialises a range of molecular assays
and instrumentation to deliver workflows and services that enable
seamless end-to-end solutions from sample to result across multiple
sectors including human health, animal health and environmental.
The Company is divided into three
business segments:
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Clinical
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Broad portfolio of human clinical
in vitro diagnostic
products, workflows and services focused on three therapeutic
areas:
·
Reproductive Health: NIPT, Cystic Fibrosis and
other rapid aneuploidy tests
·
Precision Medicine: DPYD genotyping
assay
·
Infectious Diseases: Winterplex, multiplex winter
respiratory PCR panel
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Instrumentation
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Portfolio of next generation size
selection DNA sample preparation platforms and rapid
PCR machines, including:
·
Ranger® Technology: automated DNA sample
preparation and target enrichment technology
·
genesig q16 and q32 real-time quantitative PCR
(qPCR) instruments
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Research Use Only
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Range of services for the life
sciences industry:
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Design, manufacture, and supply of
high-performance qPCR assays and workflows for use in human health,
agriculture, veterinary and environmental, to support global health
organisations and the research industry
·
Pharmaceutical research services: whole genome
sequencing (WGS) / whole exome sequencing (WES)
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Novacyt is headquartered in Le
Vésinet in France with offices in the Manchester, UK, Singapore,
the US and Canada and has a commercial presence in over 65
countries. The Company is listed on the London Stock Exchange's AIM
market ("NCYT") and on the Paris Stock Exchange Euronext Growth
("ALNOV").
For more information, please refer
to the website: www.novacyt.com
