PRESS RELEASE: September 1, 2022, 07:01 CEST
Biocartis Launch the marketing in Europe of SkylineDx innovation Merlin™ Test (CE-IVD) for melanoma The patients
Merlin helps identify melanoma patients who can safely quit sentinel lymph node biopsy
- The melanoma is deadliest form of skin cancer1
- Biocartis initiatesyou marketing in Europe of SkylineDx innovation Merlin Test, before launching anot Idylla™ version of test
Mechelen, Belgium, September 1st 2022 – Biocartis Group NV (the “Company” or “Biocartis”), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the start of commercialization in Europe of SkylineDx’s innovative Merlin test as a CE-IVD marked manual kit. The test, developed by SkylineDx in collaboration with the Mayo Clinic (USA), aims to predict a patient’s risk of lymph node metastasis with melanoma and can help to safely forego invasive surgery, which is now often performed to determine the metastatic spread of cancer for staging purposes. In about 80% of surgeries, the biopsy comes back negative for metastases, where it does not further impact the patient’s journey. Merlin Assay Provides More Personalized Insight, Identifying Low-Risk Tumor Patients Who May Avoid Surgery2. The Merlin test will be marketed in Europe by Biocartis in the form of a CE-IVD marked manual kit, before the launch of an Idylla™ version of the test which is under development.
Biocartis and SkylineDx, a private biotechnology company based in the Netherlands (Rotterdam) and the United States (San Diego, CA), announced their partnership agreement on April 22, 2021. Under the terms of the partnership agreement, SkylineDx is leading development of the Merlin test on Idylla™, while Biocartis is leading commercialization in Europe through its growing Idylla™ network. As part of the marketing in Europe, Biocartis will now also market the CE-IVD marked manual kit, before the Idylla™ version of the Merlin test. In the United States, the test is already available as a lab-developed test from SkylineDx’s CAP/CLIA lab. SkylineDx received Medicare reimbursement for the test in May 2022.
Herman Verrelst, CEO of Biocartis, said: “We are very excited to begin marketing SkylineDx’s CE-IVD marking in Europe. manual Merlin kit Test. This The manual kit is based on a well-established qPCR method that can easily be performed in molecular diagnostic laboratories. although Ithis is the first time that we market a partner test before a Idylla™ version of the test, this version of the Merlin test can offer our European customers of major molecular diagnostic laboratories already clear added value to help improve outcomes for melanoma patients. Once finished, the The Idylla™ version of the Merlin test should allow even wider access to melanoma patients across Europe, with a reduced time to results.
Dharminder VSHahal, CEO of SkylineDx, replied: “Launch the Merlin Test as a The CE-IVD marked manual kit in Europe represents a major milestone in bringing our diagnostic solutions to patients around the world. We look forward to entering this new phase of our partnership with Biocartis. »
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More information:
Renate Degrave
Corporate Communication & Investor Relations Manager Biocartis
email [email protected]
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 real-time PCR (Polymerase Chain Reaction) system that delivers accurate and highly reliable molecular information from virtually any biological sample in virtually any environment. Biocartis develops and markets an ever-expanding menu of tests addressing key unmet clinical needs, with a focus on oncology, which represents the fastest growing segment of the MDx market globally. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as COVID-19, influenza, RSV and sepsis. More information: www.biocartis.com. Follow us on Twitter: @Biocartis_.
About SkylineDx
SkylineDx is a biotechnology company focused on the research and development of molecular diagnostics in oncology and inflammatory diseases. The company is based in Rotterdam (the Netherlands) and complemented by 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 great clinical utility, helping healthcare professionals to accurately determine the type or condition of disease or to predict a patient’s response to treatment. Based on the test results, healthcare professionals can tailor the treatment approach to each patient. To learn more about SkylineDx, please visit www.skylinedx.com.
About Merlin Test
Merlin 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 combined analysis of eight genes of the patient’s primary tumor, tumor thickness and patient age; and has been analytically and clinically validated. Further clinical research and validation studies on the predictive use of the CP-GEP model are the focus of the Merlin study initiative, developed under the Falcon R&D program. More information (including references) can be obtained at www.falconprogram.com. Its American counterpart Merlin Test is commercially available and Medicare reimbursed in the United States as a laboratory-developed test insured by SkylineDx’s CAP/CLIA laboratory in San Diego (CA).
Biocartis and Idylla™ are registered trademarks in Europe, USA and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks belonging to Biocartis. Please refer to the product labeling for the 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 accessed August 24, 2022
2 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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