ROTTERDAM, Netherlands and SAN DIEGO, July 9, 2024
/PRNewswire/ -- SkylineDx, an innovative diagnostics company
specializing in the research and development of molecular
diagnostics for oncology, inflammatory, and infectious diseases,
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 [1].
MERLIN_001 was designed with the aim of prospectively validating
the Merlin Assay – a clinicopathologic GEP model – in an
independent multicenter cohort of clinically node negative primary
cutaneous melanoma patients, who are undergoing lymphatic mapping
and sentinel lymph node biopsy (SLNB) per current clinical
guidelines. The primary objective of this study is to evaluate the
ability of the Merlin Assay to predict risk of sentinel node
metastasis in melanoma patients who are candidates for SLNB.
Spanning 9 centers across the US, the study enrolled 1,640 eligible
patients over the past 3 years, reflecting a comprehensive
real-world cross-section of the melanoma patients referred for
SLNB.
Independent prospective validation is crucial for GEP testing to
show its clinical value and establish their
cost-effectiveness [2]. Previous prospective data
from the Netherlands affirmed the
performance metrics published from multiple independent
international retrospective cohorts. All of these publications
conclude that the Merlin Assay can accurately identify patients at
low risk for nodal metastasis.
Dharminder Chahal, CEO of
SkylineDx, commented: "The successful completion of patient
enrollment in the MERLIN_001 study represents a monumental
achievement in our melanoma research efforts. We are immensely
grateful to all the patients who participated and to our dedicated
team of researchers and collaborators. This study underscores our
commitment to advancing personalized medicine and improving
outcomes for melanoma patients worldwide."
Vernon K. Sondak, MD, Chair of
the Department of Cutaneous Oncology at Moffitt Cancer Center in
Tampa, FL, and Principal
Investigator of the MERLIN_001 study, added: "The importance of
this large multicenter investigation cannot be overstated. The
collaboration among leading institutions across the country has
been instrumental in driving the success of this study. The diverse
patient population and the rigorous methodology employed have
provided a robust dataset that will significantly advance our
understanding of the potential role of gene expression profiling in
melanoma, and the results will enhance patient care."
SkylineDx extends heartfelt thanks to all the patients who
participated in the MERLIN_001 study. Their confidence and
willingness to contribute to this innovative research are
invaluable. We also thank our collaborators, healthcare
professionals, and research teams for their unwavering support and
dedication.
As we move forward, SkylineDx remains committed to analyzing the
data collected and sharing comprehensive results with the medical
community. The insights gained from the MERLIN_001 study will pave
the way for more precise and personalized melanoma care, ultimately
benefiting patients globally.
About CP-GEP
CP-GEP is a non-invasive prediction model for cutaneous melanoma
patients that combines clinicopathologic (CP) variables with
gene expression profiling (GEP). This model is able to assess
metastatic potential in cutaneous melanoma patients, thus
identifying those at low risk for nodal metastasis who may
potentially safely forgo the sentinel lymph node biopsy (SLNB)
procedure. The CP-GEP model was developed by Mayo Clinic and
SkylineDx BV and it has been clinically validated in multiple
studies. More information (including references) may be obtained at
www.falconprogram.com. The test has been launched in the United States and Europe as the Merlin Assay. SkylineDx
collaborates with diagnostic service providers globally to bring
this test to market and increase access. In the United States, Tempus is commercializing
Tempus Merlin test.
Quest Diagnostics launched their own LDT version of the
CP-GEP model in the United States
under the brand name MelaNodal Predict™.
About SkylineDx
SkylineDx is a biotechnology company focused on research &
development of molecular diagnostics in oncology and inflammatory
diseases. 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. SkylineDx is
headquartered in Rotterdam. the
Netherlands, complemented by a U.S. base of operations and a
CAP/CLIA certified laboratory in San
Diego California, USA. To learn more about SkylineDx, please
visit www.skylinedx.com.
Footnotes:
- Hieken et al. MERLIN_001: A prospective registry study of a
primary melanoma gene-signature to predict sentinel node (SN)
status and determine its prognostic value for more accurate staging
of patients with SN-negative
melanoma. https://ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.TPS9606,
https://aacrjournals.org/cancerres/article/83/8_Supplement/CT053/725324/Abstract-CT053-Merlin-001-a-prospective-registry
- Grossman et al. Prognostic Gene Expression Profiling in
Cutaneous
Melanoma https://jamanetwork.com/journals/jamadermatology/article-abstract/2768743
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SOURCE SkylineDx