COMPANY:

Skyline Dx

"SkylineDx...announced the publication of an independent study showing that gene expression profiling (CP-GEP model) can be used to identify primary cutaneous melanoma patients with a high risk for disease recurrence....The CP-GEP model used in the study is an innovative integrated algorithm that combines clinicopathological features with gene expression of the primary melanoma."

"Today, SkylineDx...announces the commercial launch of Merlin Assay as CE-IVD distributable test kit in Europe. Merlin Assay identifies melanoma (skin cancer) patients that have a low risk for nodal metastasis and therefore can safely forgo a sentinel lymph node biopsy (SLNB) surgery. This is an invasive surgical procedure used to determine metastatic spread of the cancer for staging purposes."

"Biocartis Group NV...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."

"SkylineDx...announces Medicare coverage for Merlin Test. The local coverage determination was issued under the foundational policy 'Melanoma Risk Stratification Molecular Testing', by the Medicare Administrative Contractor Palmetto GBA through its Molecular Diagnostic Service Program (MolDX). This coverage provides Medicare reimbursement for Merlin Test in cutaneous melanoma (skin cancer, thickness T1b-T2) patients for which additional guidance may augment and inform clinical management decisions by physicians considering the surgical Sentinel Lymph Node Biopsy (SLNB) procedure."

"Biocartis Group NV...announced that its partner SkylineDx will present new data showing that its Merlin Test was able to prospectively reduce more than 37% of surgeries in a noninterventional study for newly diagnosed melanoma patients. The abstract publication receives a designated oral presentation during the 18th Congress of the European Association of Dermato-oncology (EADO) in Sevilla, Spain (21-23 April 2022)."

"SkylineDx announced that their Merlin Test for melanoma patients was independently validated in a Swedish (European) cohort, where it could reduce approximately a third of the surgeries in the clinically most relevant patient group (patients with pT1-2 melanomas). The Merlin Test identifies melanoma patients that can safely forgo a sentinel lymph node biopsy (SLNB) surgery, a procedure used to determine metastatic spread of the cancer for staging purposes. In approximately 80% of patients the biopsy comes back negative for metastasis and does not further impact the patient pathway. The Merlin Test provides a more personalized insight on the metastatic propensity of the tumor. The patient with a low-risk tumor could avoid surgery."

"SkylineDx announced that their Merlin Test for melanoma patients would have been able to reduce over 59% of surgery-related complications by means of deselecting patients for surgery. The commercially available Merlin Test identifies melanoma patients that can safely forgo a sentinel lymph node biopsy (SLNB) surgery, a procedure used to determine metastatic spread of the cancer for staging purposes. In approximately 80% of patients the biopsy comes back negative for metastasis and could therefore have been avoided. Merlin addresses an important clinical unmet need by identifying these patients with a low risk of metastasis at diagnosis and can therefore not only reduce unnecessary surgeries but also associated complications. Results have been published in a peer-reviewed and scientific journal, the International Journal of Dermatology."

"Today, SkylineDx announced to invest in research and development in the field of Squamous Cell Carcinoma (SCC), as part of a Dutch consortium including the Erasmus MC Cancer Institute, University Medical Center Rotterdam (EMC). The collaboration focuses on the discovery and validation of a model that identifies the SCC patient at high risk of developing metastasis...This collaboration has a unique starting point because the researchers have extensive experience and will work with the unique infrastructure of large national routinely collected health care datasets of metastatic SCC patients." "

"SkylineDx announced that the first hospitals will start including melanoma patients in a large prospective clinical study in the United States, to validate the Merlin Assay. A total of 10 hospitals are collaborating in this trial, including Moffitt Cancer Center, Mayo Clinic and University of Louisville School of Medicine led by the respective principal investigators."

"Biocartis Group NV (the ‘Company’ or ‘Biocartis’)...and SkylineDx...today announce the signing of a new partnership agreement which targets the development of SkylineDx’ novel proprietary test, the Merlin Assay, on Biocartis’ rapid and easy-to-use molecular diagnostics platform Idylla™. This assay is aimed at predicting a patient’s risk of nodal metastasis in melanoma. Under the terms of the partnership agreement, SkylineDx will lead the development of the Merlin Assay on Idylla™, while Biocartis will lead the commercialization in Europe through its growing Idylla™ network."