SKY92 – Advanced Precision for Multiple Myeloma Care

Transforming diagnosis and treatment planning through advanced gene expression profiling

Multiple Myeloma is a complex, heterogeneous disease

Multiple Myeloma (MM) is the second most common hematologic cancer, with an estimated 35,730 new cases and 12,590 deaths annually in the United States (Siegel et al., 2023)
MM is most frequently diagnosed among people aged 65 to 74 years, with the median age being 69 years. (NCCN 2024, v2)
Despite many approvals in the last years for new drugs and the introduction of the number of drug combinations, the disease remains incurable as the 5-year overall survival (OS) rate for newly diagnosed multiple myeloma (NDMM) is 48.5% (Rajkumar, 2022).

SKY92 is a standardized assay based on 92 genes extracted from malignant plasma cells to assess the myeloma’s aggressiveness at diagnosis. Developed on a microarray platform, SKY92 is a CE-IVD marked kit in Europe and CLIA validated Lab Developed test in the United States.

The outcome of the test is binary:

Standard-risk

the myeloma is less aggressive; these patients have a favorable progression free and overall survival.

High-risk

the myeloma is aggressive; these patients have a worse progression free and overall survival.

Developed on a microarray platform, SKY92 is a CE-IVD marked kit in Europe and CLIA validated Lab Developed Test in the United States.

How Does SKY92 Work?

Fully standardized sample work-up process, data analysis and reporting results:

Day 1

Bone marrow aspirate collected in EDTA or herpin.

Day 2

Minimum 200.000 plasma cells (CD138 positive) isolated within 32h from BM aspirate.

Day 3

Minimum of 200ng of total RNA.

Days 3/4

MMprofiler Analysis

Day 4

Physician / Patient Review Report

Successful rate. OPTIMUM trial (UK): 88% to determined both GEP and genetic risk markers. Median turn around time 2 weeks.

SKY92 is fully analytically validated with a high success rate

Analytical validation of the SKY92 assay was performed with primary bone marrow specimens of Multple Myeloma patients and cell line specimens in 3 independent laboratories.

Peer-reviewed manuscript detailing analytical validation; including reported assay success rate of 92%. Read more here.

SKY92 has the most extensive validation across both trial and real-world cohorts and categorizes around 20-25% of NDMM as high-risk (Rees et al, 2024).

The SKY92 signature is the only fully accredited GEP signature and has consistent performance in detecting high-risk in myeloma”

SKY92 […] has the most extensive validation across both trial and real-world cohorts and categorizes around 20% of NDMM patients as high-risk. The PROMMIS trial evaluated SKY92s influence on risk stratification and treatment decision making, herein SKY92 results led to risk reclassification […] and altered treatment decisions [..]. This effect may be because SKY92 captures a previously hidden HRMM group who lack HRCAs […].

How SKY92 Helps Patients

For 88% of the patients tested it was possible to determine both SKY92 and genetic risk markers (6% partial results – 7% no results)
Median time for patients to receive a risk status result was 18 days (IR:13-22; range 0-37 days)

Order SKY92

Contact our team to set up test orders:

Discuss SKY92 with your clinician to see if it’s right for you.

Frequently Asked Questions

Who is eligible for SKY92?

Yes, every submission that we receive will be evaluated by our team.

How is the test performed?

We will contact you initially within one working day. For the proposal, the review depends on the length and details, we will communicate with you how soon we can discuss it.

How long does it take to get results?

We will send a CDA or NDA after your initial inquiry to ensure we keep your IP safe.

How does SKY92 compare to traditional methods?

This will be discussed during the evaluation process.

Newest publications

First author: Weitemeyer

Journal / Conference: Nordic Melanoma Meeting

Using a clinicopathologic and gene expression model to predict sentinel lymph node metastasis in primary cutaneous melanoma could reduce the rate of sentinel lymph node biopsies with >70%: a multicentre Danish cohort study.

An independent Danish validation study has confirmed the Merlin Assay’s efficacy in predicting nodal metastases.

First author: Stassen

Journal / Conference: EADV 2024

Impact of CP-GEP to improve selection of patients with melanoma who may forgo sentinel lymph node biopsy based on real world data

First author: Sondak et. al

Journal / Conference: SMR 2024

Prospective multicenter evaluation (MERLIN_001 trial) of a clinicopathologic and gene expression profile test to predict sentinel node status in T1-T3 cN0 melanoma

Findings in a combined US and EU multi-center validation study show the potential ability of CP-GEP to support in risk stratifying patients with T1a melanoma.

Journal / Conference: SMR 2024

CP-GEP Identifies T1a Melanoma Patients At Risk of Sentinel Lymph Node Metastasis

Findings in a combined US and EU multi-center validation study show the potential ability of CP-GEP to support in risk stratifying patients with T1a melanoma.

Latest News

April 4, 2025

SkylineDx Presents Landmark Study on Merlin CP-GEP beyond SLNB prediction: Transforming Melanoma Risk Assessment

ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), April 4, 2025—SkylineDx, an innovative diagnostics company specializing in molecular diagnostics for oncology, inflammatory, and infectious diseases, proudly announces that Dr. Teresa Amaral MD, PhD,...

March 28, 2025

SkylineDx Presents Landmark Findings from the Largest Prospective Multicenter Melanoma GEP trial at SSO 2025

ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), March 28, 2025—SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology , inflammatory and infectious diseases, proudly announces...

March 12, 2025

SkylineDx Announces New Study Demonstrating Enhanced Risk Stratification for Sentinel Lymph Node Biopsy in Head and Neck Melanoma Using the Advanced Merlin CP-GEP test

ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), March 12, 2025—SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology and, inflammatory and infectious diseases, proudly announces...

February 28, 2025

SkylineDx Announces New Publication On SKY92 Gene Expression Profiling Test in Defining Ultra-High-Risk Multiple Myeloma

ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), February 28, 2025—SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, and inflammatory and infectious diseases, announces the...

December 7, 2024

New Data from PROMMIS Study Highlights the Power of SKY92 in Identifying High-Risk Multiple Myeloma Patients

ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), December 7, 2024—SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases, announce that groundbreaking...

October 24, 2024

Independent meta-analyses by Melanoma Institute of Australia on CP-GEP model in Melanoma Care

ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), October 25, 2024—SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases, announced today the...