SkylineDx Triumphs Again as 'Diagnostics Company of the Year' in BioTech Breakthrough Awards 2026

SkylineDx Achieves Back-to-Back Triumph in BioTech Breakthrough Awards

SkylineDx has once again made headlines by winning the prestigious title of 'Diagnostics Company of the Year' at the BioTech Breakthrough Awards, solidifying its position as a leader in molecular diagnostics. This recognition marks the second consecutive year that the Rotterdam-based company has received this honor, demonstrating its unwavering commitment to enhancing clinical decision-making in oncology and dermatology.

This year’s award emphasizes SkylineDx’s innovative contributions to the field of precision medicine, particularly through its leading molecular diagnostic tests—Merlin™ CP-GEP and the SKY92 test. These tests are designed to meet critical needs in specialty oncology, addressing challenges for patients suffering from melanoma and multiple myeloma.

In 2026, the company celebrated two significant milestones for the Merlin CP-GEP test. In February, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines to recognize Merlin as a predictive gene expression profile test. This acknowledgment allows clinicians to better assess metastatic risks for select patients suffering from T1b and T2a melanoma, further integrating precision medicine into treatment protocols.

Additionally, in July, the U.S. Food and Drug Administration (FDA) granted the Merlin CP-GEP test 'Breakthrough Device Designation.' This distinction positions it as the first melanoma gene expression profiling test to hold this status while also being recognized in the NCCN Guidelines. Dharminder Chahal, the CEO of SkylineDx, commented on this accomplishment, noting that the award underscores their rigorous clinical research and commitment to bridging the gap between scientific discovery and commercial diagnostics.

Merlin CP-GEP is uniquely designed to provide personalized risk assessments of metastatic melanoma by integrating clinical and gene expression data. This innovative approach allows for significant improvements in patient management, helping clinicians make informed decisions about potential sentinel lymph node biopsies—potentially sparing patients from unnecessary procedures. The non-invasive test boasts multiple validations in global studies and is marketed as a laboratory developed test (LDT) in the U.S. and carries CE-IVD/UKCA marks in Europe and the UK.

Bryan Vaughn, Managing Director at BioTech Breakthrough, praised SkylineDx for transforming healthcare through its cutting-edge molecular diagnostic tests. He highlighted the critical need for innovations that facilitate faster, more accurate determinations of cancer progression, stating that when clinicians are equipped with precise tools, they can make better-informed treatment decisions that directly impact patient survival.

Beyond Merlin, SkylineDx has additional programs such as Falcon RD, which targets dermato-oncology, and Panthera RD for hemato-oncology, showcasing the company's broad commitment to advancing the field of molecular diagnostics. The company also emphasizes its dedication to addressing unmet medical needs and expanding its commercial presence, evidenced by its collaboration with renowned institutions like the Mayo Clinic and Erasmus MC.

The BioTech Breakthrough Awards serve to spotlight the innovators redefining the life sciences landscape through advanced technologies, including areas such as AI-driven drug discovery and next-generation diagnostics. SkylineDx continues to stand out in this competitive field, consistently delivering groundbreaking solutions that lead the way in precision medicine and ultimately improve patient outcomes.

For more information on SkylineDx and its revolutionary diagnostic tests, you can visit their official website at SkylineDx.

In summary, SkylineDx’s recent award serves not just as a recognition of past achievements but as a clarion call to continue innovating in the ever-important field of molecular diagnostics. With its eyes on the future, SkylineDx is paving the way for transformative healthcare solutions, ensuring that patients receive the most informed and personalized care possible.