COMPANY:

Skyline Dx

"SkylineDx...announce that groundbreaking data on the Prognostic Value of the SKY92 Classifier over High-Risk Cytogenetic Aberrations in Multiple Myeloma will be presented during the upcoming American Society of Hematology (ASH) conference...the significant impact of SKY92 on risk stratification in multiple myeloma patients...Patients that had the high-risk biomarker SKY92 had significantly worse progression-free survival rates, regardless of whether they had other genetic abnormalities."

"The results showed that individual chromosomal abnormalities and their co-occurrence had limited prognostic value, with the sole exception of the 1q21 abnormality, which prognostic significance for PFS was exclusive to patients aged 65 years and older. SKY92 proved to be a much stronger predictor of poor outcomes. Patients that had the high-risk biomarker SKY92 had significantly worse progression-free survival rates, regardless of whether they had other genetic abnormalities....The research also showed that combining SKY92 results with specific genetic markers like gain(1q21) could offer even more detailed insights. For example, patients flagged as high-risk by both tests had some of the poorest outcomes, underlining the complementary value of using SKY92."

"SkylineDx...announces that late-breaking data evaluating its Merlin test will be presented as part of the Plenary Session and a poster presentation at the upcoming Society for Melanoma Research (SMR) being held from October 10-13, 2024, in New Orleans, LA."

"SkylineDx...proudly announces the successful enrollment of the MERLIN_001 study. This study is the largest independent multicenter prospective investigation to date into the role of Gene Expression Profiling (GEP) testing in melanoma care. This milestone marks the conclusion of enrollment with the final patient now included in this groundbreaking prospective registry study."

"SkylineDx...SkylineDx announces the presentation of groundbreaking data at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting. Dr. Teresa Amaral, MD, PhD, medical oncologist from the University of Tuebingen, Germany, will present findings on the identification of patients at high-risk for relapse in an independent cohort of 432 patients with stage I/II melanoma who did not undergo sentinel lymph node biopsy (SLNB)"

"SkylineDx is pleased to announce two forthcoming scientific publications at the European Association for Dermato-Oncology congress, April 4-6, 2024. These publications show Merlin test’s (CP-GEP model) ability to identify early-stage cutaneous melanoma patients at high risk for relapse."

"SkylineDx...announces the forthcoming presentation of an impactful poster by Dr. Yu from University Hospital Cleveland Medical Center at the upcoming AAD Annual Meeting in San Diego. The abstract concludes that the CP-GEP assay improved risk stratification for nodal metastasis and disease recurrence in patients with cutaneous melanoma...The analysis unveiled Merlin test’s pivotal role in effectively stratifying CM patients based on their risk of disease recurrence."

"SkylineDx and NeraCare today announced that they will not continue their strategic partnership. The initial intent was to identify and collaborate in areas where the companies would have synergies for further assay development and optimization of NeraCare's IHC assay. After an evaluation phase both companies jointly concluded that they will proceed independently."

"SkylineDx...is excited to announce that the European Patent Office (EPO) has granted European Patent No. 3827101, marking a groundbreaking advancement in the field of cancer diagnostics and personalized treatment. This patent introduces innovative approaches to classify and treat individuals afflicted with primary cutaneous melanoma based on the expression levels of gene expression signature , providing the foundation for highly precise diagnosis and personalized treatment plans."

"SkylineDx...is announcing a strategic commercial collaboration with Tempus, a leader in precision medicine. This collaboration aims to advance patient care by expanding the accessibility to the SkylineDx Merlin™ Test, further solidifying both companies' commitment to improving patient outcomes...The Merlin™ Test is a molecular diagnostic tool developed by SkylineDx, designed to provide personalized insights into early-stage melanoma cancer patients' treatment options....This collaboration marks a significant milestone in the journey to advance precision medicine and personalized healthcare. By combining the strengths of SkylineDx and Tempus, the collaboration is poised to further improve accessibility for patients to the latest medical innovations."

"SkylineDx...is pleased to announce the forthcoming presentation of an impactful poster by Dr M.E. Egger at the upcoming Society for Melanoma Research Congress in Philadelphia. Dr. M.E. Egger's presentation promises to usher in a new paradigm in disease staging and management for cutaneous melanoma (CM) patients in the United States...This retrospective study included primary CM patients who underwent sentinel lymph node biopsy (SLNB) at six renowned medical institutions in the United States....The results revealed that CP-GEP low-risk patients exhibited substantially better long-term survival when compared to their high-risk counterparts, confirming the model's potential to identify a subgroup of Stage I/II CM patients at higher risk for disease recurrence."

"SkylineDx...proudly announces the successful clinical validation and implementation of the clinicopathologic and gene expression profile (CP-GEP) model in a multicenter Dutch study focused on patients with melanoma....The CP-GEP model demonstrated an overall negative predictive value (NPV) of 96.7% and a positive predictive value (PPV) of 23.7% and showed a potential SLNB reduction rate of 42.2% in patients with T1-T3 melanoma."

P=NA | N=NA | "SkylineDx...announced that a new peer-reviewed publication will be presented during the International Myeloma Society 20th Annual Meeting and Exposition by Dr. Martin F. Kaiser 'Defining high risk and ultra-high risk MM....Importantly, outcome of UHRMM patients treated with intensified Dara-CVRd in OPTIMUM was markedly improved over that of a digital comparator group of trial patients identified by SKY92 or standard of care genetics from the UK Myeloma XI trial: at 30 months, progression free survival (PFS) was 77% in OPTIMUM vs. 39.8% for Myeloma XI treatment. This Myeloma XI treatment is similar to standard of care. At 30 months follow up, the overall survival (OS) rate was 83.5%, vs. 73.5% using the conventional method."

"Oncode Investigator Miao-Ping Chien...in collaboration with SkylineDx received a TKI-LSH PPP Allowance to kickstart a project aimed at investigating the underlying mechanisms that drive metastasis in head and neck squamous cell carcinoma (HNSCC). Their approach is to leverage FUNseq, a cutting-edge technology developed and validated in Chien’s lab, to functionally profile the aggressive subpopulations of cancer cells and characterize them by single-cell sequencing."

"SkylineDx, an innovative diagnostics company focused on research & development of molecular diagnostics for oncology and inflammatory diseases, today announced its first non-academic strategic partnership with NeraCare GmbH from Frankfurt, Germany to co-develop a test to help life science companies bring lifesaving melanoma therapies to market...The agreement includes an exclusive co-development and licensing agreement for Immunoprint®. SkylineDx and NeraCare will work together to accelerate the development of Immunoprint®, while leveraging SkylineDx’s global network, and discovery and validation expertise."

"SkylineDx, an innovative diagnostics company focused on research & development of molecular diagnostics for oncology and inflammatory diseases, today announced research demonstrating significant cost-saving potential with use of its Merlin test, which may reduce the rate of unnecessary sentinel lymph node biopsies (SLNB) in SLNB-eligible patients with cutaneous melanoma." "

"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."