Press release Biocartis Group NV: Biocartis Initiates
Commercialization in Europe of SkylineDx’s Innovative Merlin™ Assay
(CE-IVD) for Melanoma Patients
PRESS RELEASE: 1 September 2022, 07:01 CEST
Biocartis Initiates
Commercialization in Europe
of SkylineDx’s Innovative
Merlin™ Assay
(CE-IVD) for Melanoma
PatientsMerlin helps identify melanoma patients
who may safely forgo the sentinel lymph node biopsy
- Melanoma is the deadliest form of
skin cancer1
- Biocartis to initiate
commercialization in Europe of SkylineDx’s innovative Merlin Assay,
ahead of the launch of an Idylla™ version of the test
Mechelen, Belgium, 1
September 2022
– Biocartis Group NV (the ‘Company’ or
‘Biocartis’), an innovative molecular diagnostics company (Euronext
Brussels: BCART), today announces the start of the
commercialization in Europe of SkylineDx’s innovative Merlin Assay
as a CE-IVD marked manual kit. The test, developed by SkylineDx
together with the Mayo Clinic (US), aims to predict a melanoma
patient’s risk of nodal metastasis and may help safely forgo an
invasive surgery, which is now often performed to determine
metastatic spread of the cancer for staging purposes. In
approximately 80% of surgeries, the biopsy comes back negative for
metastasis, where it does not further impact the patient pathway.
Merlin Assay provides a more personalized insight, identifying
patients with a low-risk tumor that could avoid the surgery2. The
Merlin Assay will be commercialized in Europe by Biocartis as a
CE-IVD marked manual kit, ahead of the launch of an Idylla™ version
of the test which is under development.
Biocartis and SkylineDx, a Dutch (Rotterdam) and
US (San Diego, California) based private biotechnology company,
announced their partnership agreement on 22 April 2021. Under the
terms of the partnership agreement, SkylineDx is leading the
development of the Merlin Assay on Idylla™, while Biocartis is
leading the commercialization in Europe through its growing Idylla™
network. As part of the commercialization in Europe, Biocartis will
now also commercialize the CE-IVD marked manual kit, ahead of the
Idylla™ version of the Merlin Assay. In the US, the test is already
available as a Laboratory Developed Test serviced from SkylineDx’
CAP/CLIA laboratory. SkylineDx received Medicare reimbursement for
the test in May 2022.
Herman Verrelst, Chief Executive Officer
of Biocartis, commented: “We are very excited to start
commercialization in Europe of SkylineDx’s CE-IVD marked manual kit
of the Merlin Assay. This manual kit is based on a well-established
qPCR method that can easily run in molecular diagnostic
laboratories. Although it’s the first time we are commercializing a
partner test ahead of an Idylla™ version of the test, this version
of the Merlin Assay may offer our European customer base of large
molecular diagnostic labs already a clear added value to help
improve outcomes for melanoma patients. Once completed, the Idylla™
version of the Merlin Assay is expected to allow an even broader
access for melanoma patients across Europe, with reduced time to
results.”
Dharminder
Chahal,
Chief Executive Officer of SkylineDx, replied: “Launching
the Merlin Assay as a CE-IVD marked manual kit in Europe signifies
a major milestone in making our diagnostic solutions available to
patients globally. We are looking forward to enter this new phase
of our partnership with Biocartis.”
--- END ---
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
Biocartis (Euronext Brussels: BCART) is an
innovative molecular diagnostics (MDx) company providing next
generation diagnostic solutions aimed at improving clinical
practice for the benefit of patients, clinicians, payers and
industry. Biocartis' proprietary MDx Idylla™ platform is a fully
automated sample-to-result, real-time PCR (Polymerase Chain
Reaction) system that offers accurate, highly reliable molecular
information from virtually any biological sample in virtually any
setting. Biocartis is developing and marketing a continuously
expanding test menu addressing key unmet clinical needs, with a
focus in oncology, which represents the fastest growing segment of
the MDx market worldwide. Today, Biocartis offers tests supporting
melanoma, colorectal and lung cancer, as well as for COVID-19, flu,
RSV and sepsis. More information: www.biocartis.com. Follow us
on Twitter: @Biocartis_.
About SkylineDxSkylineDx is a
biotechnology company focused on research & development of
molecular diagnostics in oncology and inflammatory diseases. The
company is headquartered in Rotterdam (the Netherlands) and
complemented with a commercial team, a field medical and scientific
affairs team and a CAP/CLIA certified laboratory in San Diego (CA,
USA). SkylineDx uses its expertise to bridge the gap between
academically discovered gene expression signatures and commercially
available diagnostic products with high clinical utility, assisting
healthcare professionals in accurately determining the type or
status of disease or predicting a patient’s response to treatment.
Based on test results, healthcare professionals can tailor the
treatment approach to the individual patient. To learn more about
SkylineDx, please visit www.skylinedx.com.
About Merlin
AssayMerlin Assay uses the CP-GEP model, a
powerful proprietary algorithm that calculates the risk of
metastasis in a patient’s sentinel lymph nodes3. The model is able
to calculate risk on an individual basis through a combination
analysis of eight genes from the patient’s primary tumor, the tumor
thickness and the patient’s age; and has been analytically and
clinically validated. Further clinical research and validation
studies on the predictive use of the CP-GEP model is the main focus
of Merlin Study Initiative, developed under the wings of Falcon
R&D Program. More information (including references) may be
obtained at www.falconprogram.com. Its US counterpart Merlin Test
is commercially available and Medicare reimbursed in the United
States as a Laboratory Developed Test serviced from SkylineDx’s
CAP/CLIA laboratory in San Diego (CA).
Biocartis and Idylla™ are registered trademarks
in Europe, the United States and other countries. The Biocartis and
Idylla™ trademark and logo are used trademarks owned by Biocartis.
Please refer to the product labeling for applicable intended uses
for each individual Biocartis product.
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1 Source:
https://www.nccn.org/patients/guidelines/content/PDF/melanoma-patient.pdf,
last consulted on 24 August 20222 Bellomo et al., Model combining
tumor molecular and clinicopathologic risk factors predicts
sentinel lymph node metastasis in primary cutaneous melanoma. JCO
Precision Oncology (2020). https://doi.org/10.1200/PO.19.00206. 3
Bellomo et al., Model combining tumor molecular and
clinicopathologic risk factors predicts sentinel lymph node
metastasis in primary cutaneous melanoma. JCO Precision Oncology
(2020). https://doi.org/10.1200/PO.19.00206
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