SkylineDx Wins 2026 BioTech Breakthrough Award for "Diagnostics Company of the Year" for Second Consecutive Year
- This award recognizes SkylineDx's dedication to advancing precision molecular diagnostics that empower clinicians to make more informed decisions and improve patient care
- Annual BioTech Breakthrough Awards Program recognizes innovation in life sciences and biotechnology innovation around the world
ROTTERDAM, Netherlands and SAN DIEGO, Nov. 5, 2026 /PRNewswire/ -- SkylineDx, an innovative diagnostics company specializing in the research, development and commercialization of molecular diagnostics for dermatology and oncology, today announced it has been named "Diagnostics Company of the Year" for the second consecutive year in the sixth annual BioTech Breakthrough Awards program for its portfolio of molecular tests that address unmet needs in specialty oncology disease states, including Merlin CP-GEP1 for melanoma and the SKY92 test for multiple myeloma.
In 2026, Merlin CP-GEP reached two important milestones. In February, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) updated its Clinical Practice Guidelines in Oncology for Cutaneous Melanoma to recognize CP-GEP (Merlin CP-GEP) as a predictive gene expression profile test that may be used to support metastatic risk assessment in select patients with T1b and T2a melanoma2. The guidelines reference positive MERLIN_001 trial3 data showing that patients classified as high risk have roughly a threefold greater likelihood of sentinel lymph node (SLN) positivity. In July, the U.S. Food and Drug Administration (FDA) granted Merlin CP-GEP Breakthrough Device Designation, making it the first and only melanoma gene expression profiling test that is both designated as an FDA Breakthrough Device and recognized in the NCCN Guidelines.
"Being named Diagnostics Company of the Year for a second consecutive year reflects our team's focus on rigorous clinical research, the highest quality scientific data, and clinical relevance, priding ourselves on bridging the gap between discovered biomarkers and commercially available diagnostic assays," said Dharminder Chahal, CEO of SkylineDx. "Our commercial efforts are integral to this focus by strengthening our clinical, sales, and marketing teams, and expanding our footprint globally."
Merlin CP-GEP, developed with the Mayo Clinic for early-stage cutaneous melanoma, combines clinicopathologic factors with gene expression data into a single integrated algorithm, producing a personalized binary high-risk or low-risk prediction of melanoma metastases, as well as long term survival estimates, that map directly to surgical decision-making. This can help identify patients who may forgo an unnecessary SLN biopsy while flagging those at higher risk. The non-invasive test has been clinically validated in multiple studies globally and is marketed as a laboratory developed test (LDT) in the U.S. and as the CE-IVD/UKCA-marked Merlin Assay across the EU, EEA and UK.
"SkylineDx is transforming healthcare by offering molecular diagnostic tests that address current unmet medical needs," said Bryan Vaughn, Managing Director, BioTech Breakthrough. "The distance between academic biomarker discovery and clinical diagnostic use is where promising science usually stalls out. This gap is especially consequential in oncology, where a wrong call on whether cancer has spread can reshape a patient's treatment and survival odds. SkylineDx provides the translational rigor to turn discovery into a validated tool that helps clinicians risk-stratify patients, make faster, more personalized referral decisions, and spare patients from unnecessary procedures."
SkylineDx's additional programs include Falcon R&D for Dermato-Oncology, Panthera R&D for Hemato-Oncology, and Delphia R&D for Infectious and Inflammatory Diseases. The company continues to work in multiple myeloma with SKY92, the globally validated and Guidelines recognized gene expression profiling test developed with Erasmus MC, backed by a CAP/CLIA-certified laboratory in San Diego and a nationwide U.S. commercial organization alongside the company's European base.
The mission of the annual BioTech Breakthrough Awards program is to recognize the innovators transforming the global biotechnology and life sciences landscape with breakthrough technology. The program conducts a comprehensive analysis of the companies redefining how therapies are researched, developed, manufactured and delivered. From AI-driven drug discovery platforms and precision medicine to synthetic biology, bioinformatics, and next-generation diagnostics and biomanufacturing, these innovations are enabling life sciences organizations to accelerate research, reduce development costs, bring life-changing treatments to market faster, and shape the future of human health.
About Merlin CP-GEP
Merlin CP-GEP is a molecular test developed to provide additional information regarding a melanoma patient's risk of sentinel lymph node metastasis. By combining clinicopathologic factors with gene expression profiling, Merlin CP-GEP is designed to support more individualized clinical decision-making regarding sentinel lymph node biopsy. Merlin CP-GEP is now the first and only melanoma gene expression profiling test that is both designated as an FDA Breakthrough Device and recognized in the NCCN Guidelines for T1b and T2a cutaneous melanoma patients. More information may be obtained at www.merlinmelanomatest.com.
About SkylineDx
SkylineDx is a molecular diagnostics company focused on developing and commercializing innovative molecular diagnostic solutions that enable more personalized clinical decision-making. Through its growing direct U.S. commercial and clinical organization, SkylineDx is committed to advancing evidence-based precision medicine and providing clinicians with the scientific, clinical and operational support needed to integrate molecular diagnostics into patient care. To learn more about SkylineDx, please visit www.skylinedx.com.
About BioTech Breakthrough
Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the BioTech Breakthrough Awards program is devoted to honoring excellence in life science and biotechnology solutions, services and companies. The BioTech Breakthrough Awards provide public recognition for the achievements of biotechnology companies and products in categories including BioPharma, Genomics, Therapeutics, Immunology, Food Science and BioAgriculture, and more. For more information visit BioTechBreakthroughAwards.com
Tech Breakthrough LLC does not endorse any vendor, product or service depicted in our recognition programs, and does not advise technology users to select only those vendors with award designations. Tech Breakthrough LLC recognition consists of the opinions of the Tech Breakthrough LLC organization and should not be construed as statements of fact. Tech Breakthrough LLC disclaims all warranties, expressed or implied, with respect to this recognition program, including any warranties of merchantability or fitness for a particular purpose.
Media Contact
ICR Healthcare
Ally Stubin
ally.stubin@icrhealthcare.com
SkylineDx Contact
Linda Forlani
Corporate Affairs Manager
press@skylinedx.com
FOOTNOTES
(1) MERLIN CP-GEP IS MARKETED IN THE USA AS AN LDT. IN THE EU EEA AND UK, IT IS MARKETED UNDER THE NAME MERLIN ASSAY, A CE-IVD AND UKCA MARKED DEVICE.
(2) National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Cutaneous Melanoma (Version 3.2026)
(3) Gene Expression Profile-Based Test to Predict Melanoma Sentinel Node Status: The MERLIN_001 Study | Dermatology | JAMA Surgery | JAMA Network
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