TEST:

Merlin Assay

The Merlin Assay effectively categorizes head and neck melanoma patients by risk, enabling more accurate clinical decision-making regarding SLNB and follow-up evaluation, especially for early-stage melanoma patients.

"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."

P=N/A; Recruiting --> Active, not recruiting | Trial completion date: Aug 2028 --> Jun 2029

"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)"

This study shows that CP-GEP has the potential to stratify pts with early-stage melanoma who did not undergo SLNB based on their risk of recurrence. Pts with CP-GEP Low-Risk have a good long-term survival. Contrary, pts with CP-GEP High-Risk have a high risk of recurrence.

"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."

While various tissue-based molecular testing platforms have the potential to stratify the risk of sentinel lymph node positivity (SLNP), most suffer from significant methodological deficiencies, including limited sample size, lack of prospective validation, and limited correlation with established clinicopathological variables. Furthermore, the genes and proteins identified by individual gene expression profiling (GEP) or immunohistochemistry (IHC) tests exhibit minimal overlap, even when considering the most well-established melanoma mutations. However, there is hope that the ongoing prospective trial for the Merlin Assay may safely reduce the necessity for SLNB procedures if successful. Additionally, the MelaGenix GEP and Immunoprint tests could prove valuable in identifying high-risk stage I-II melanoma patients and potentially guiding their selection for adjuvant therapy, thus potentially reducing the need for SLNB. Due to the diverse study designs employed, effective comparisons between GEP or IHC tests are challenging, and to date, there is no study directly comparing the clinical utility of these respective GEP or IHC tests.

Pts with CP-GEP Low-Risk have a good long-term survival compared to pts with High-Risk, even though SLN status was not assessed. This also seems true for patients with H&N melanoma, which may allow clinicians to skip SLNB in this difficult anatomic localization.

"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."

Conclusion CP-GEP improves risk stratification for nodal metastasis and disease recurrence, thereby supporting clinical decision making and optimizing healthcare resources. Specifically, recurrence events may be more effectively captured by CP-GEP as compared to current standard of care.

Merlin loss is a relatively frequent finding in renal carcinomas that show a wide range of morphologies and very aggressive clinical behavior. Thus, Merlin IHC is recommended for evaluation of all high-grade unclassifiable renal carcinomas and primary renal carcinomas with an infiltrative growth pattern. Based on the morphologic heterogeneity of these tumors (including <50% that fulfill the typical BHP-RCC descriptions) and the unknown frequency of NF2 biallelic loss in such high grade non-BHP RCCs, a further study is warranted to elucidate the group of "Merlin-Deficient Renal Cell Carcinomas".

P=N/A; N=2340; Recruiting; Sponsor:SkylineDx

CP-GEP has the potential to categorize primary CM patients of the head and neck based on their risk for nodal metastasis and long-term survival outcomes. Notably, CP-GEP can help identify patients with tumors in surgically challenging locations who potentially may avoid SLNB surgery, while more accurately pinpointing those truly at risk for melanoma-specific death.Learning Objectives: Understand CP-GEP has potential to stratify cutaneous melanoma patients of head and neck based on their risk for nodal metastasis and long-term survival outcome. Understand CP-GEP can help identify patients with tumors in surgically challenging locations who potentially may avoid SLNB surgery and who are truly at risk for melanoma-specific death.

"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."

With a median time of 16 days from initiation to return of test results, there was sufficient time left before the SLNB was performed. Based on these outcomes, the model may support clinical decision-making to identify patients who can forgo SLNB in clinical practice.

"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."

"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." "

Addition of Merlin IHC to the current standard BAP1 + MTAP immunopanel increases sensitivity for PeM from 69% to 80%. Some PeM with retained Merlin show weak or cytoplasmic staining, which may complicate interpretation. MTAP IHC is much less sensitive for PeM than for PlM, even when subclonal MTAP loss is regarded as diagnostic of malignancy.

Merlin testing for T1b and T2 melanoma is potentially cost saving depending on the cost of the molecular assay and SLNB reimbursement rates. In addition to being cost saving, Merlin is expected to improve health-related quality of life.

"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."

P=N/A; Trial completion date: Apr 2028 --> Aug 2028 | Trial primary completion date: Dec 2023 --> Apr 2024

While CP-GEP is still being validated in prospective studies, preliminary data suggest that it is an independent predictor of nodal metastasis, outperforming clinicopathological variables. The hunt is on for Breslow thickness 2.0.

"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."

This is the first prospective multicenter implementation study for the Merlin assay. Results are in line with previous validation studies. The CP-GEP model could accurately identify patients at low risk for SN metastasis.

Corporate presentation

"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)."

"GEP tests provide additional, reproducible information for dermatologists to consider within the larger framework of the eighth edition of the AJCC and NCCN cutaneous melanoma guidelines when counseling regarding prognosis and when considering a sentinel lymph node biopsy."

"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."

No abstracts available

"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."

SLNB is a safe procedure but carries a significant complication rate. Merlin testing might reduce the need for SLNB and its associated complications.

This study demonstrates that CP-GEP can identify patients with a low risk for nodal metastasis. Patients with pT1-2 melanomas have the highest clinical benefit from using the test, where 35% of the patients could forgo a SLNB procedure.

P=N/A; Not yet recruiting --> Recruiting | Initiation date: Apr 2021 --> Aug 2021

We confirmed the potential of CP-GEP to reduce negative SLNB in all relevant age groups. Our findings are especially relevant to patients ≥65 years, where surgery is often elective. CP-GEP may guide SLNB decision-making in clinical practice.

"The CP-GEP model is a non-invasive tool that can adequately identify stage II cutaneous melanoma patients at high risk for disease relapse within five years, as demonstrated in this European cohort. These results indicate the possible added value of using the CP-GEP model in current clinical practice. CP-GEP High Risk patients may benefit from therapeutic interventions or enhanced surveillance."

"The CP-GEP model is a non-invasive and validated tool that can be used to identify patients with a primary cutaneous melanoma who are at low risk for nodal metastasis, and therefore could safely forego SLNB. Also, during the current COVID-19 pandemic, the CP-GEP model could be a promising tool to deselect patients for elective surgery."

"The CP-GEP model has now been independently validated in a European retrospective patient cohort, and can be used to identify patients who may safely forgo SLNB procedure due to their low risk for nodal metastasis."