Press release Biocartis Group NV: Biocartis and HiloProbe to
Collaborate on Colorectal Cancer Test
PRESS RELEASE: 9 May 2023, 07:00 CEST
Biocartis and
HiloProbe to Collaborate
on Colorectal
Cancer Test
Mechelen, Belgium, 9
May 2023 - Biocartis Group NV (the
‘Company’ or ‘Biocartis’), an innovative molecular diagnostics
company (Euronext Brussels: BCART), and HiloProbe, a Umeå (Sweden)
based biotechnology company focused on personalizing colorectal
cancer diagnostics, today announce that they entered into a
collaboration that will initially focus on the commercialization of
ColoNode®, a CE-marked IVD gene expression signature test that can
help detect nodal metastasis in colorectal cancer (CRC) patients.
ColoNode® will be distributed as a manual kit by Biocartis to
expert laboratories in selected European countries.
CRC is the third most common cancer type in the
world with an estimated 1.9 million new cases and 0.9 million
deaths per year worldwide1. 70-90% of CRC patients may undergo
surgical resection of the tumor. International guidelines2 have
introduced the tumor-node-metastasis (TNM) staging system, that
assesses primary tumor (T), lymph node metastasis (N), and distant
metastasis (M) to predict disease recurrence and survival. As a key
component in this staging system, lymph nodes that are contained in
the resected section of the colon, are inspected for presence of
disseminated tumor cells. Lymph node status is also a key factor in
deciding on post-operative adjuvant chemotherapy. The routine
method of determining lymph node status (pN) is microscopic
examination of H&E3 stained lymph node tissue sections, that
has limitations: it is insensitive and subjective, requires
specially trained pathologists, examines < 1% of the lymph node
volume and cannot differentiate between aggressive and relatively
harmless tumor cells.
ColoNode® is a CE-marked IVD gene expression
test that detects and characterizes tumor cells in post-operative
CRC lymph node samples. The ColoNode® kit can analyze up to 100% of
the lymph node volume and is more sensitive in detecting tumor
cells than H&E staining. Additionally, the test provides an
estimation of the risk of CRC recurrence based on the tumor
aggressiveness markers included in the ColoNode® kit4.
The partnership will initially focus on the
commercialization of the ColoNode® CE-marked IVD manual kit in
selected European countries by Biocartis. Following commercial
uptake of the manual kit, HiloProbe and Biocartis will consider
developing a fully automated version of the test on Biocartis’
decentralized Idylla™ platform.
Roger Moody, Chief
Executive Officer of Biocartis, commented: “We are pleased
to partner with HiloProbe on the distribution of the ColoNode® kit.
This allows us to broaden our product offering to customers in the
colorectal cancer domain, complementing tests for RAS biomarkers
and MSI on our Idylla™ platform. The collaboration supports our
mission to maximize patient access to precision medicine in
oncology.”
Lina Olsson, Chief Executive
Officer of
HiloProbe, added: “We are very
happy to start a collaboration and a long-term relationship with
Biocartis, which strengthens our focus on colorectal cancer thanks
to Biocartis’ established sales and distribution network across
many countries. Further development of a fully automated version of
ColoNode® on the Idylla™ platform also holds great potential for
ColoNode® to contribute faster and more easily to the safer
selection of patients who could benefit from postoperative adjuvant
treatment.”
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More information: Renate
DegraveHead of Corporate Communications & Investor Relations
Biocartise-mail rdegrave@biocartis.com tel
+32 15 631 729
mobile +32 471 53 60 64
About Biocartis
With its revolutionary and proprietary Idylla™
platform, Biocartis (Euronext Brussels: BCART) aspires to enable
personalized medicine for patients around the world through
universal access to molecular testing, by making molecular testing
actionable, convenient, fast and suitable for any lab. The Idylla™
platform is a fully automated sample-to-result, real-time PCR
(Polymerase Chain Reaction) based system designed to offer in-house
access to accurate molecular information in a minimum amount of
time for faster, informed treatment decisions. Idylla™'s
continuously expanding menu of molecular diagnostic tests address
key unmet clinical needs, with a focus in oncology. This is the
fastest growing segment of the molecular diagnostics market
worldwide. Today, Biocartis offers tests supporting melanoma,
colorectal, lung, liver and breast cancer, as well as for COVID-19,
Flu, RSV and sepsis. For more information,
visit www.biocartis.com or follow Biocartis on Twitter
@Biocartis_ , Facebook or LinkedIn. About
HiloprobeHiloProbe is a biotechnology company
founded 2016. The founders consist of a group of scientists, who
have collaborated for more than 15 years in an academic setting and
have produced high quality original research focusing on the
development of clinically useful biomarkers in colorectal cancer.
The research has been focused on analysis of the regional lymph
nodes in the resected specimen. The reason is that the lymph node
is the first site where metastasizing cancer cells will occur. We
have now discovered a limited number of biomarkers that, when
analyzed together, identify tumor cells in the lymph node and grade
tumor cell aggressiveness i.e. their propensity to metastasize to
distant sites. A product (ColoNode®), based on biomarker mRNA
analysis, has been developed. The aim is to bring ColoNode® to the
market to save people´s lives and aid in the development of more
efficient treatment of colorectal cancer.
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1 Globocan 2020 and Xi and Xu. Global colorectal
cancer burden in 2020 and projections to 2040. Translational
Oncology 14 (2021): 1011742 American Joint Committee on Cancer
(AJCC) and International Union Against Cancer (UICC)3 H&E
(hematoxylin-eosin) stain is the most widely used tissue staining
used in histopathology4 Ohlsson et al. Int J Cancer 2012, 130:
1833; Ohlsson et al. Br J Cancer 2012, 107: 150; Olsson et al, PLoS
ONE 2020, 15: e0229007; Olsson et al. Dis Colon Rectum 2021, 64:
1354.
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