GENinCode PLC Positive Thrombo inCode clinical results (3534G)
26 July 2021 - 4:00PM
UK Regulatory
TIDMGENI
RNS Number : 3534G
GENinCode PLC
26 July 2021
GENinCode Plc
("GENinCode" or the "Company")
Positive Thrombo inCode clinical results
Case study carried out with the Karolinska Institute
GENinCode Plc (AIM: GENI), Oxford, UK, the cardiovascular
disease company focused on predictive genetics for the prevention
of cardiovascular disease, announces the publication of its Thrombo
inCode (R) prospective case-control study performed at the
Karolinska Institute, Sweden.
The study returned positive clinical results which strengthen
Thrombo inCode (R) as a leading diagnostic product for the
diagnosis of inherited thrombophilia and venous thromboembolism
("VTE") risk assessment. The Karolinska Institute is one of the
world's leading medical universities with a vision to advance
knowledge about life and strive towards better health for all.
Thrombo inCode (R) is CE Marked and one of the Group's three
primary products of commercialisation focus over the immediate
term. Thrombo inCode(R) is focused on the diagnoses of genetic
thrombophilia and assesses thrombotic risk. Thrombophilia is a
condition where there is an imbalance in naturally occurring blood
clotting proteins or clotting factors giving rise to the formation
of blood clots. Inherited thrombophilia arises from genetic factors
which affect the blood clotting mechanism, with clotting events
increasingly recognised as a significant source of cardiovascular
events, mortality and morbidity.
In the Karolinska study, Thrombo inCode (R)'s performance was
tested against the current diagnostic Standard of Care for
thrombophilia, including Factor V Leiden and Prothromobin, and a
combination of genetic and clinical risk scores. The Thrombo
inCode(R)results showed Thrombo inCode(R)'s predictive capacity was
superior to the current Standard of Care, with a much higher
sensitivity allowing the identification of 2.5 times more patients
with hereditary thrombophilia. The study publication can be viewed
at
https://www.thieme-connect.com/products/ejournals/pdf/10.1055/s-0041-1729626.pdf
There is a growing increase in patients with cardiovascular
diseases ("CVD") and cancer risk owing to adoption of smoking,
alcohol, increasing obesity, lack of physical activity and
consumption of high cholesterol food. CVD and cancer patients also
have a high risk of VTE, with cancer patients having a higher risk
of developing blood clots with associated treatment procedures
along with their inherited genetics. The growing incidence in CVD
and cancer and other contributing risk factors means the demand for
VTE diagnosis and treatment is growing. VTE treatment market size
exceeded USD $950 million in 2020 and is expected to expand at over
8.7% CAGR from 2021 to 2027.
Thrombo inCode (R) clinical utility has also been proven and
validated in a Southern European group (Soria et al., JAHA 2014)
and in Afro-Americans (McInnes et al., Human Mutation 2019), where
it is increasingly recognised as the Gold-Standard for VTE risk
prediction.
Matthew Walls, CEO, GENinCode Plc said: "The Karolinska
Institute study provides further evidence for Thrombo inCode (R)
and the importance of understanding the genetic characteristics of
the patient to properly assess risk and precisely align appropriate
therapeutic treatment. We are delighted by the study results and
grateful to the team at the Karolinska Institute for their
significant contribution."
GENinCode plc www.genincode.com
Matthew Walls, CEO Via Walbrook PR
Paul Foulger, CFO
Stifel Nicolaus Europe Limited (Nomad Tel: +44 (0)20 7710
and Joint Broker) 7600
Alex Price / Ben Maddison /
Richard Short
Cenkos Securities Plc (Joint Tel: +44 (0)20 7397 8900
Broker)
Giles Balleny
Dale Bellis / Michael Johnson
(Sales)
Walbrook PR Limited Tel: 020 7933 8780 or genincode @walbrookpr.com
Anna Dunphy / Paul McManus /
Louis Ashe-Jepson
About Thrombo inCode (R)
The Thrombo inCode (R) genetic test analyses genetic variants
related to hereditary thrombophilia and the risk of venous
thromboembolism (VTE). Thrombo inCode(R) genetic diagnosis has been
published in a number of scientific journals and the Company's test
has begun to be implemented in hospitals and laboratories in
Europe. Thrombo inCode(R) provides individuals who have a family
history of thrombosis with detailed information regarding
hereditary thrombophilia to help prevent the occurrence of
thrombosis and identify treatment pathways, as well as reduce the
risk of recurrence.
The symptoms of thrombosis include swelling, localised warmth,
pain and reddening of the affected area, caused by a clot that
blocks blood flow. It generally occurs in the deep veins of the
lower limbs and is also known as deep vein thrombosis (DVT). The
most severe complication of thrombosis is a pulmonary embolism,
caused by a clot that affects blood flow in the pulmonary arteries.
By carrying out a thrombophilia test, it is possible to determine
whether an individual's genetic profile increases their risk of
thrombosis. At present, two genetic variants are usually measured
as the Standard of Care, Factor: V Leiden; and Prothrombin.
However, there are other thrombosis-related genetic variants that
can be considered which are captured by the Thrombo inCode (R)
test. Studies have highlighted that a clinical-genetic score
integrating the variants of Thrombo inCode(R) has good predictive
capacity to identify patients with a high risk of thrombosis
recurrence.
The Thrombo inCode (R) test personalises therapy options for
patients, including oral anticoagulants, such as Warfarin, Xarelto,
Eliquis and/or Heparins.
About GENinCode plc
GENinCode plc (AIM: GENI) is engaged in the risk assessment,
prediction and prevention of cardiovascular disease ("CVD"). CVD is
the leading cause of death worldwide accounting for approximately
18 million deaths annually. The Company's products and technology
have been developed with the aim of predicting the onset of CVD and
providing a personalised treatment pathway for patient management.
Its products have been the subject of clinical studies on over
75,000 patients to assess and predict the onset of CVD.
The Company was incorporated in September 2018 to acquire the
assets, intellectual property and know-how of the Ferrer inCode and
Gendiag.exe businesses, which were then part of Grupo Ferrer
Internacional S.A., a large Spanish multinational private
pharmaceutical and healthcare company. The technology and products
acquired included Cardio inCode(R), Lipid inCode(R), Thrombo
inCode(R) and Sudd inCode(R). The Directors believe that
approximately EUR50 million has been invested in the research and
development of these products since 2007. The Company has begun to
commercialise these products in Europe and is now targeting the UK
and US.
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