SkylineDx Announces Commercial Collaboration with Tempus to Advance Patient Care with its Merlin™ Test

ROTTERDAM, Netherlands and SAN DIEGO, Dec. 5, 2023 /PRNewswire/ -- SkylineDx, an innovative diagnostics company focused on research & development of molecular diagnostics for oncology and inflammatory diseases, 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. By harnessing the power of advanced genomic profiling, the Merlin™ Test empowers healthcare providers with precise information to make informed decisions tailored to each patient's unique genetic profile. Since the discovery of the model¹ was published, international validation studies^2-4 and recently a prospective study⁵ have consistently demonstrated the strong performance of the test. The test was developed to identify patients at low risk for sentinel node metastasis. Through the collaboration with Mayo Clinic, this test successfully integrates      clinical and pathological information in its algorithm to predict the risk for nodal metastasis. This clinical evidence enabled Medicare coverage under the MolDX local coverage determination for Melanoma Risk Stratification. Tempus, renowned for its expertise in leveraging the power of artificial intelligence and data to drive advancements in healthcare, brings its experience and vast commercial network to this collaboration.

"We are excited to embark on this new collaboration with Tempus," said Dharminder Chahal, CEO of SkylineDx. "Their reputation for innovation and commitment to improving patient outcomes aligns perfectly with our vision. This partnership is one of the key pillars of our commercialization strategy that aims to bring the SkylineDx Merlin™ Test to a wider audience, ensuring that more melanoma patients have access to personalized treatment options that can significantly impact their lives."

Tempus' precision medicine  platform will play a pivotal role in streamlining the delivery of the Merlin™ Test to patients and healthcare providers across the United States. The collaboration between SkylineDx and Tempus will not only enhance the availability of the Merlin™ Test but also foster a deeper understanding of its clinical utility through data-driven insights.

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.

About the Melanoma Merlin test

The Merlin test uses the CP-GEP model, a powerful proprietary algorithm that calculates the risk of metastasis in a melanoma patient's sentinel lymph nodes¹. The model is able to calculate risk on an individual basis through a combination analysis of 8 genes from the patient's primary tumor, the tumor thickness, and the patient's age; and has been analytically and clinically validated. More information (including references) may be obtained at www.falconprogram.com. The Merlin test is commercially available and reimbursed by Medicare as a Laboratory Developed Test serviced from SkylineDx's CAP/CLIA laboratory in San Diego (CA).

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.

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world's largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

Footnotes:

1. Bellomo et al. 2020. JCO Precision Oncology. Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma.  
2. Johansson et al. 2021. EJSO. Validation of a clinicopathological and gene expression profile model to identify patient with cutaneous melanoma where sentinel lymph node biopsy is unnecessary.
3. Yousaf et al. 2021. IJ Dermatology. Validation of CP-GEP (Merlin Assay) for predicting sentinel lymph node metastasis in primary cutaneous melanoma patients: a U.S. cohort study.
4. Mulder et al. 2020. BJD.  Validation of a clinicopathological and gene expression profile model for sentinel lymph node metastasis in primary cutaneous melanoma.
5. Stassen et al. 2023 EJSO. Clinical evaluation of the clinicopathologic and gene expression profile (CP-GEP) in patients with melanoma eligible for sentinel lymph node biopsy: A multicenter prospective Dutch study https://www.ejso.com/article/S0748-7983(23)00887-9/fulltext