OncoBEAM™ for Lung Cancer

Obtain an accurate, real-time snapshot of mutations before initiating treatment

No tissue means fewer delays and highly accurate results

Analyzing mutations in tumor tissue may have considerable drawbacks. Not only is there a risk of complications, but it can take weeks to get results. Numerous clinical trials show that tissue is insufficient for molecular testing in up to 50% of cases.1

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

Multiple non-small cell lung cancer mutations, one solution

Clinical practice guidelines for the treatment of non-small cell lung cancer (NSCLSC) recommend a combination of EGFR, KRAS, and BRAF testing to provide a comprehensive mutational analysis.2-5 OncoBEAM™ tests for this trifecta of mutations.

Our Test Menu

OncoBEAM™ Lung1: EGFR

EGFR:
Sensitizing Mutations: Del 19, L858R, L861Q
Resistant Mutations: T790M, C797S

OncoBEAM™ Lung2: EGFR, KRAS, BRAF

EGFR:
Sensitizing Mutations: Del 19, L858R, L861Q
Resistant Mutations: T790M, C797S
KRAS: Codons 12, 13 ,and 61
BRAF: V600E

EGFR mutations and TKI therapy

NSCLC tumors with sensitizing EGFR mutations have increased sensitivity to tyrosine kinase inhibitors (TKIs). Patients who initially respond to TKI therapy frequently relapse, with 60% of those on TKIs developing resistance due to the EGFR T790M mutation.4-5

OncoBEAM™ EGFR can identify the T790M mutation in patients who have progressed on first-line TKI therapy, delivering rapid results and avoiding the need for a repeat tissue biopsy.6

60% of patients on EGFR TKI therapy develop resistance due to the EGFR T790M mutation.7

KRAS: the most prevalent NSCLC mutation

KRAS mutations occur in 25% of NSCLC cases.8 Independent of therapy, KRAS mutations can indicate poor survival rates compared to tumors without KRAS mutations.

OncoBEAM™ KRAS can identify multiple KRAS mutations, providing a more complete picture of a patient’s condition to rapidly inform critical therapy decisions.

KRAS MUTATIONS OCCUR IN 25% OF NSCLC CASES.8

BRAF testing precedes first-line therapy

BRAF mutations are detected in approximately 3% of patients with NSCLC.8 The 2017 NCCN guidelines now include BRAF V600E mutation testing for all newly diagnosed patients in order to inform appropriate administration of first-line therapy, which now includes BRAF targeted therapies.2

OncoBEAM™ BRAF tests for the BRAF V600E mutation, helping doctors to decide whether to initiate first-line therapy as soon as possible.

BRAF MUTATIONS ARE DETECTED IN APPROXIMATELY 3% OF PATIENTS WITH NSCLC.8

Case scenario

Avoiding a repeat biopsy

A 64-year-old woman was diagnosed with stage IV NSCLC. Her tumor was EGFR positive. She responded well to EGFR TKI therapy with substantial tumor shrinkage and disease stabilization.

Following initial treatment

  • CT-scan showed disease progression in multiple sites, suggesting 1st line EGFR TKI resistance
  • Repeat biopsy was considered to evaluate for the presence of a T790M mutation
  • Patient was hesitant to undergo another tissue biopsy

The OncoBEAM™ solution

OncoBEAM™ EGFR can test for the EGFR T790M mutation amongst multiple sites of disease with a simple blood draw, avoiding the need for an additional tissue biopsy.

FAQs

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

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

Does OncoBEAM™ detect all gene mutations like sequencing?

Not quite. OncoBEAM™ detects mutations in hot spot locations in clinically relevant genes that are indicated in clinical practice guidelines for patient care.

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

Yes. Plasma mutation status correlates well with response to therapy and there is growing evidence that it can be used to understand tumor activity and disease progression.9, 10

Can BEAMing be used for all cancer stages?

OncoBEAM™ can be used for most cancers where the tumor has accessed the circulatory system and released ctDNA, Multiple tumor types have been shown to shed ctDNA including: lung, colorectal, pancreatic, prostate, breast, melanoma. Certain cancers, such as gliomas, have ctDNA levels that are too low to detect.11

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

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. Reck, M. et al. Tissue sampling in lung cancer: a review in light of the MERIT experience. Lung Cancer Amst. Neth. 74, 1–6 (2011).
  2. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: non-small cell lung cancer, version 3.2015. http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed 2017.
  3. Travis WD, Brambilla E, Noguchi M, et al. (2011) International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society international multidisciplinary classification of lung adenocarcinoma. J Thorac Oncol. 6(2):244-285.
  4. Keedy VL, Temin S, Somerfield MR, et al. (2011) American Society of Clinical Oncology Provisional Clinical Opinion: epidermal growth factor receptor (EGFR) mutation testing for patients with advanced non-small-cell lung cancer considering first-line EGFR tyrosine kinase inhibitor therapy. J Clin Oncol. 29(15):2121-2127.
  5. Lindeman NI, Cagle PT, Beasley MB, et al. (2013) Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. J Thorac Oncol. 8(7):823-859.
  6. Oxnard, G. R. et al. Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non-Small-Cell Lung Cancer. J. Clin. Oncol. 34, 3375–3382 (2016).
  7. Yu, H. A. et al. Analysis of tumor specimens at the time of acquired resistance to EGFR-TKI therapy in 155 patients with EGFR-mutant lung cancers. Clin. Cancer Res. 19, 2240–2247 (2013).
  8. NCCN guidelines Non-Small Cell Lung Cancer 2.2018
  9. 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
  10. Piotrowska, Z. et al. Heterogeneity Underlies the Emergence of EGFRT790 Wild-Type Clones Following Treatment of T790M-Positive Cancers with a Third-Generation EGFR Inhibitor. Cancer Discov (2015). doi:10.1158/2159-8290.CD-15-0399
  11. 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.