SKY92 – Advanced Precision for Multiple Myeloma Care

Transforming diagnosis and treatment planning through advanced gene expression profiling

What is Multiple Myeloma?

Multiple Myeloma (MM) is a complex and genetically diverse blood cancer that originates in plasma cells, specialized white blood cells found in the bone marrow. It is the second most common blood cancer.

MM develops when malignant plasma cells multiply uncontrollably in the bone marrow, leading to an excessive buildup of abnormal myeloma cells. These cells produce monoclonal proteins (M-proteins), which can cause serious complications, including:

  • Hypercalcemia (elevated calcium levels)
  • Kidney dysfunction
  • Anaemia (low red blood cell count)
  • Bone damage, such as osteoporosis, bone pain, or fractures

MM is a highly heterogeneous disease, meaning it varies significantly from patient to patient in terms of genetic profile, disease progression, and treatment response.

MM typically follows a relapsing-remitting pattern, where treatment becomes less effective with each recurrence. This makes accurate risk assessment at diagnosis critical for selecting the right treatment approach especially during first-line therapy, which has a major impact on long-term outcomes.

While MM remains a serious and currently incurable condition, advances in molecular diagnostics and targeted therapies are improving the ability to predict disease behaviour and personalize care, offering new hope for better outcomes.

What is SKY92?

SKY92 is a molecular diagnostic test developed by SkylineDx designed specifically for patients with Multiple Myeloma (MM) — both newly diagnosed and those with relapsed or refractory disease.

It analyses the expression of 92 genes — known as the SKY92 signature — in myeloma cells to uncover prognostic information not available through standard diagnostic methods.

SKY92 empowers clinicians with more precise risk stratification, enabling informed treatment decisions which can improve the outcomes of patients.

The SKY92 test provides two possible outcomes:

High Risk

indicates a higher likelihood of aggressive, progressive disease and reduced overall survival.

Standard Risk

indicates a more favourable prognosis, with a lower risk of rapid disease progression and better expected survival outcomes.

How does MMprofiler work?

Step-by-step flow

Step 1

Bone marrow aspirate collected from the patient

Step 2

CD138+ plasma cells isolated within 32 hours

Step 3

RNA extracted and analysed for expression of 92 genes

Step 4

Data processed through a validated algorithm

Result

Patient is stratified into standard-risk or high-risk

Test results are delivered within 4 working days.

Multiple Myeloma (MM) is a highly heterogeneous disease, meaning it does not behave the same in every patient. While some individuals experience a slow-growing, manageable form, others develop aggressive disease that relapses quickly, even after initial treatment success.

Approximately 20–25% of newly diagnosed patients fall into this high-risk category, often driven by underlying genetic abnormalities in their myeloma cells.

MM typically follows a relapsing-remitting pattern, where treatment becomes less effective with each recurrence. This makes the first line of therapy especially critical, as a strong initial response can significantly impact long-term outcomes.

Identifying a patient’s risk level at diagnosis allows doctors to tailor treatment strategies more effectively:

  • Those with stable, slow-growing disease (commonly referred to as standard risk) may do well with conventional therapies and could benefit from less intensive treatment, helping preserve options for future relapses.
  • On the other hand, individuals with fast-progressing, genetically unstable disease (often labelled as high risk) typically require more intensive first-line treatment and ongoing close monitoring from the beginning.

Despite the importance of early risk assessment, many of the tools used in routine practice lack standardization, leading to inconsistent or unclear results. As a result, patients may miss key opportunities, such as enrolling in clinical trials suited to their risk level, receiving the right intensity of treatment (either more aggressive or less intensive), or accessing timely supportive care when they need it most.

MM typically follows a relapsing-remitting pattern, where treatment becomes less effective with each recurrence. This makes accurate risk assessment at diagnosis critical for selecting the right treatment approach especially during first-line therapy, which has a major impact on long-term outcomes.

While MM remains a serious and currently incurable condition, advances in molecular diagnostics and targeted therapies are improving the ability to predict disease behaviour and personalize care, offering new hope for better outcomes.

How SKY92 can help

SKY92 provides a standardized, risk classification based on tumour biology/genomics during diagnosis, helping clinicians make confident, personalized treatment decisions. By revealing the disease’s biological behaviour early, it guides clinicians providing better targeted strategies, potentially improving outcomes for both high- and standard-risk patients.

Why SKY92 matters

Traditional clinical markers like FISH often miss a subset of aggressive myeloma cases. The SKY92 gene expression profile identifies 10–15% of high-risk patients who are not detected by standard tests, enabling earlier, more tailored intervention. This finding has been consistently validated in multiple clinical trials worldwide.

SkylineDx journey with SKY92

2012

Discovery SKY92 signature (Kuiper et al.) 
A gene expression signature for high-risk multiple myeloma | Leukemia 

2015

CE-IVD test certification

2018
  1. LDT test certification;
  2. Prospective study at RCSI (Ireland)
    HemaSphere;

Test results are delivered within 4 working days.

Guidelines that recommend MMprofiler

Onkopedia

Myeloma Australia’s Medical and Scientific Advisory Group (MSAG)

Good Practice Paper British Society of Haematology/UK Myeloma Society

MM profiler results to date

3,500+ patients validated across 17 clinical cohorts

Developed in collaboration with 16 academic institutions worldwide

Featured in 20+ peer-reviewed publications

Clinically and analytically validated across 3 continents: the U.S., Europe, and Australia

Presented in 60+ abstracts at leading international hematology and oncology conferences

SKY92 identifies 10–15% of high-risk MM patients missed by traditional methods like FISH, delivering powerful insights not captured by standard care

Order SKY92

Contact Us to Order the Test

Frequently Asked Questions

What’s the difference between MMprofiler and SKY92?
  • SKY92 is the proprietary 92-gene expression signature used to determine risk.
  • MMprofiler is the commercial platform in EU that performs the SKY92 test and integrates it into clinical practice with standardized, validated workflows.

While traditional tests like FISH (Fluorescence In Situ Hybridization) identify certain chromosomal abnormalities, MMprofiler detects gene expression patterns that reveal biological behavior missed by standard methods. In fact, MMprofiler identifies 10–15% of high-risk patients not captured by clinical markers like FISH.

MMprofiler is suitable for patients with newly diagnosed or relapsed/refractory Multiple Myeloma, especially when a more precise risk assessment could impact treatment planning. It is typically ordered by hematologists or oncologists managing MM care.

MMprofiler has been analytically and clinically validated in multiple international studies.

MMprofiler supports personalized medicine by:

  • Identifying hidden high-risk patients
  • Guiding treatment intensity
  • Improving long-term management and patient outcomes

The MMprofiler test is completed in approximately 4 working days in the laboratory. In a clinical setting, accounting for sample logistics and processing workflows, results are typically delivered in less than 3 weeks from the time of sample collection (Ref)

Unfortunately, MMprofiler is not available globally, if not available in your country please make an inquiry via (EMAIL)

The tests have been clinically validated by X international institutions, to know more, read our publications

Latest News

Real-world prospective data confirms improved risk stratification in multiple myeloma using SKY92 gene expression profiling

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

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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,...

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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...

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...

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...