OncoBEAM™ for Melanoma

Exquisite sensitivity for more effective treatment

Clear guidance for therapy selection and monitoring

While clinical practice guidelines already encourage molecular testing to advise metastatic melanoma treatment options, clinicians need a faster, clearer picture of disease progression.

Thanks to our highly-sensitive BEAMing technology, a liquid biopsy with OncoBEAM™ requires only a simple blood draw to access tumor DNA and provide a real-time view of a tumor’s mutation status in 5 to 7 days.

Get results in 5–7 days

Patient visits clinic for blood draw

Patient visits clinic for blood draw

Sample is tested with OncoBEAM™

Sample is tested with OncoBEAM™

Results are reported within 5-7 days

Results are reported within 5-7 days

OncoBEAM™ assays for melanoma provide results in just 5 to 7 days from our CLIA-certified laboratory, helping doctors to make faster treatment decisions for patients.

BRAF and NRAS: Unprecedented biomarkers for melanoma

OncoBEAM™ BRAF and NRAS assays detect ctDNA to deliver results a physician can use to monitor a patient’s cancer progression, and response to treatment.1 Combined with standard of care medical imaging, OncoBEAM™ test results can help streamline patient management by providing unique insight into tumor activity.

Our Test Menu

OncoBEAM™ Melanoma1: BRAF, NRAS

NRAS: Codon 61
BRAF: V600E, V600K

OncoBEAM™ Melanoma2: BRAF

BRAF: V600E, V600K

Guiding targeted therapy for BRAF mutations

Melanoma tumors with activating BRAF mutations are shown to respond to BRAF inhibitors, improving overall response rates and prolonging survival rates when compared to chemotherapy.2 The most common BRAF-activating mutations occur at residue V600.3

OncoBEAM™ BRAF can detect the V600E and V600K mutations, allowing physicians to make more rapid treatment decisions based on a systemic mutation assessment of a patient’s tumor.

Approximately 40 to 50% of melanoma tumors harbor BRAF mutations.3

NRAS mutations occur in 15-20% of melanoma cases and can indicate consideration for novel targeted therapies4

Despite high initial response rates to BRAF-targeted monotherapy, about half of patients develop drug resistance in six months. NRAS mutations are associated with therapy resistance in up to 20% of patients receiving BRAF inhibitor therapy.5,6

OncoBEAM™ can detect detect the most frequently mutated NRAS mutations, helping to provide insight into potential therapy resistance.

About 15 to 20% of melanoma tumors harbor NRAS mutations.4

Case scenario

Obtaining a rapid mutation analysis

A 43-year-old patient arrived at a hospital with a large, unusual bleeding mass and a low hematocrit of 21%.

Following intake

  • Routine, preliminary workup determined advanced melanoma with lung metastases
  • A tumor tissue biopsy and blood biopsy with OncoBEAM™ were obtained
  • After collection, both samples were sent for mutation analysis

The OncoBEAM™ solution

The OncoBEAM™ biopsy revealed a BRAF V600E mutation in just three days (10 fewer than the tissue biopsy). The patient was immediately put on combination BRAF/MEK inhibitor therapy and experienced a rapid response.

FAQs

Can OncoBEAM™ be used with multiple melanoma tumor mutation biomarkers?

Yes. Clinically actionable multigene detection panels are available to assess the mutational status of a tumor.

Is it possible to use the plasma OncoBEAM™ assay to monitor melanoma tumor dynamics?

Yes. Plasma mutation status correlates well with response to therapy and there is a growing body of evidence showing that it can be used to predict disease progression.7,8

What is the difference between ctDNA and CTCs?

ctDNA refers to small fragments of DNA that are not associated with cells or cell fragments released from a tumor into the bloodstream. Circulating Tumor Cells (CTCs) are cells shed from primary and/or metastatic tumor deposits and circulate in the bloodstream. CTCs may constitute seeds for subsequent growth of additional tumors (metastases) in vital distant organs.

There are indications that ctDNA is often present without detectable CTCs. ctDNA levels may be higher than CTCs in certain tumor types. Some studies have also shown that ctDNA has greater sensitivity for mutation detection than CTCs.8

How are OncoBEAM™ tests billed and reimbursed?

Sysmex Inostics accepts all insurance plans, but OncoBEAM™ tests are currently not in-network with most carriers. We are working to become in-network with payors. Sysmex Inostics directly bills insurance or Medicare and patients are not responsible for any balance that is not covered by insurance or Medicare. Deductibles may apply if applicable. Sysmex Inostics does not accept uninsured or Medicaid patients at this time.

Get a real-time snapshot of your patient's tumor

Order an OncoBEAM™ collection kit

Download a test requisition form

Complete and send to our lab with your patient’s blood sample for testing

Access the Provider Portal

Log in to view test results and the latest clinical content from OncoBEAM™

Request more information

Get answers to your questions about OncoBEAM™

References:

  1. Lipson, E. J. et al. Circulating tumor DNA analysis as a real-time method for monitoring tumor burden in melanoma patients undergoing treatment with immune checkpoint blockade. J Immunother Cancer 2, 42 (2014).
  2. Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011;364(26):2507-2516. doi:10.1056/NEJMoa1103782.
  3. Hodis, E. et al. A landscape of driver mutations in melanoma. Cell 150, 251–263 (2012).
  4. Jakob, J. A. et al. NRAS mutation status is an independent prognostic factor in metastatic melanoma. Cancer 118, 4014–4023 (2012).
  5. Nazarian, R. et al. Melanomas acquire resistance to B-RAF(V600E) inhibition by RTK or N-RAS upregulation. Nature 468, 973–977 (2010).
  6. Shi, H. et al. Acquired resistance and clonal evolution in melanoma during BRAF inhibitor therapy. Cancer Discov 4, 80–93 (2014).
  7. Diehl F., Schmidt K., Choti M.A., Romans K., Goodman S., Li M., Thornton K., Agrawal N., Sokoll L., Szabo S.A., Kinzler K.W., Vogelstein B., Diaz L.A. Jr. Circulating mutant DNA to assess tumor dynamics. Nature Medicine 2008; 14, 985-990 / Holdenrieder et al, Presented at Sysmex Inostics Symposium; June 2, 2014
  8. Bettegowda C, Sausen M, Leary R, Kinde I, Wang Y, Agrawal N, et al. Detection of Circulating Tumor DNA in Early- and Late-Stage Human Malignancies. Sci Transl Med Feb 2014; 224(6):224ra24.