Study validates SkylineDx's Merlin test can avoid surgery and lower healthcare costs

ROTTERDAM, Netherlands and SAN DIEGO, Calif., April 12, 2023 /PRNewswire/ -- 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.

The SLNB procedure is currently the standard of care, and the most prognostic tool available for determining the course of treatment for patients with cutaneous melanoma. Yet 80% of SLNB results are negative and non-therapeutic, and according to a recent study published by the International Journal of Dermatology, can add nearly $10,000 to the cost of treatment.

The SkylineDx molecular Merlin test helps identify melanoma patients who are at low risk for nodal metastasis,  and may subsequently forgo aSLNB procedure. At a Medicare reimbursement rate of $4,600 per test, the Merlin test could significantly reduce the number of unnecessary surgeries, and the overall cost of care for cutaneous melanoma.

"These findings support our mission to improve a patient's quality of life by providing reliable genomic-level insights about their disease," said Jvalini Dwarkasing, Chief Scientific Officer of SkylineDx. "The Merlin test, when incorporated into the patient's melanoma journey, will help arm physicians with the information needed to guide the treatment pathway, avoid unnecessary surgery, and reduce overall costs to the healthcare system."

About Merlin

The Merlin test, which was developed in collaboration with Mayo Clinic, uses the CP-GEP model, a powerful proprietary algorithm that calculates the risk of metastasis in a patient's sentinel lymph nodes. 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. The Merlin test is commercially available and Medicare reimbursed as a Laboratory Developed Test serviced from SkylineDx's CAP/CLIA laboratory in San Diego (CA).

More information about Merlin can be found at www.falconprogram.com.

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

1. Thao et al., Cost evaluation of the Merlin assay for predicting melanoma sentinel lymph node biopsy metastasis. International Journal of Dermatology (2022). https://doi.org/10.1111/ijd.16515.
2. Hieken et al., Using the Merlin assay for reducing sentinel lymph node biopsy complications in melanoma: a retrospective cohort study. International Journal of Dermatology (2022). https://doi.org/10.1111/ijd.16056.
3. Agnese et al., Cost-effectiveness of sentinel lymph node biopsy in thin melanomas. Surgery (2023). https://doi.org/10.1016/S0039-6060(03)00275-7.
4. Bellomo et al., Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma. JCO Precision Oncology (2020). https://doi.org/10.1200/PO.19.00206.