Cancer of Unknown or Uncertain Primary (CUP) cases constitute 12%-15% of all newly diagnosed cancers per year in the United States.1 These cases can represent a clinical dilemma, because without knowing the primary origin, it can be difficult to select the optimal therapy for patients. RosettaGX Cancer Origin is designed to help provide a diagnosis for such cases. It utilizes proven, proprietary microRNA technology, along with a custom microarray platform to deliver highly accurate results.

RosettaGX Cancer Origin also provides easy reflexing options to other solid tumor assays. With CORE (Cancer Origin REflex), we partner with physicians to help them identify their patient’s tumor of origin and uncover the best treatment path by reflexing to the most appropriate solid tumor assay in our portfolio. This allows physicians to more efficiently get all the information needed to properly diagnose and decide on a treatment plan for their patients who need the best answers and care possible, as quickly as possible.

Provides a single answer with 90% sensitivity, never reports more than two possible answers1

88-92% concordance in post-marketing studies with leading cancer centers1,3

Measures just 64 microRNA biomarkers to identify 49 cancer origins

Rapid turnaround time of 4-7 days

Rosettagx CoreTM
Get the results you need more quickly and more efficiently so you can provide the best care possible for your patients.

• When you select RosettaGX CORE on your test requisition form, our lab will know to run the Cancer Origin assay
• Automatically reflex to the next appropriate assay in our portfolio based on the initial results
• This saves time not only when it comes to diagnosing your patient, but also knowing how to proceed forward with targeted treatment

References

  1. Meiri E, Mueller W, Rosenwald S, et al. A Second-Generation microRNA-Based Assay for Diagnosing Tumor Tissue Origin. Oncologist. 2012;17(6):801-812.
  2. Rosenwald S, Gilad S, Benjamin S, et al. Validation of a microRNA based qRT-PCR test for accurate identification of tumor tissue origin. Mod Pathol. 2010;23(6):814-823.
  3. Pentheroudakis G, Pavlidis N, Fountzilas G, et al. Novel microRNA-based assay demonstrates 92% agreement with diagnosis based on clinicopathologic and management data in a cohort of patients with carcinoma of unknown primary. Mol Cancer. 2013;12(1):57.
Recommended Use

When it comes to identifying the tumor of origin for cancer of uncertain or unknown origin, it’s not whether to use this test — it’s when.

In the following instances, accurately identifying the tissue of origin in a timely manner is crucial to help select optimal treatment.

When the diagnosis is Cancer of Unknown/Uncertain Primary origin

For atypical presentation or discordant findings

For failure to respond as expected to treatment

When growing evaluation costs need to be managed and reduced in patients with Cancers of Unknown or Uncertain Primary origin

When a basic IHC panel (8–10 slides) does not yield a definite diagnosis or indicate how to proceed

When knowing the tissue of origin may be important for family members of patients with cancers that may have genetic links and risk implications, such as colorectal and breast

When a fast, reliable diagnostic tool is needed to help identify the tumor origin when faced with a diagnostic challenge (e.g. initial examination suggestive of multiple possible origins)

To help determine which additional stains may help reach a definitive diagnosis sooner

References

  1. Meiri E, Mueller W, Rosenwald S, et al. A Second-Generation microRNA-Based Assay for Diagnosing Tumor Tissue Origin. Oncologist. 2012;17(6):801-812.
  2. Rosenwald S, Gilad S, Benjamin S, et al. Validation of a microRNA based qRT-PCR test for accurate identification of tumor tissue origin. Mod Pathol. 2010;23(6):814-823.
  3. Pentheroudakis G, Pavlidis N, Fountzilas G, et al. Novel microRNA-based assay demonstrates 92% agreement with diagnosis based on clinicopathologic and management data in a cohort of patients with carcinoma of unknown primary. Mol Cancer. 2013;12(1):57.
Technology

RosettaGX Cancer Origin utilizes proprietary technology developed by Rosetta Genomics for extraction and quantification of microRNAs. Based on the expression level of the extracted microRNAs, the test utilizes 2 classifiers to assign a predicted primary origin.

This test uses custom-designed microarray technology and can identify 49 cancer origins by measuring the expression level of 64 microRNAs.

While many of the cancer tests currently available are largely qualitative and subjective, the measurement of microRNA expression levels in tissue samples offers a quantitative, objective diagnosis. Proprietary technologies enable microRNA profiling with high sensitivity and specificity (for the 1st generation test, these values have been shown to be 90% and 99%, respectively).2 In addition, microRNAs are stable markers in many body fluids and tissue samples, making them an ideal platform for molecular diagnostics.

References

  1. Meiri E, Mueller W, Rosenwald S, et al. A Second-Generation microRNA-Based Assay for Diagnosing Tumor Tissue Origin. Oncologist. 2012;17(6):801-812.
  2. Rosenwald S, Gilad S, Benjamin S, et al. Validation of a microRNA based qRT-PCR test for accurate identification of tumor tissue origin. Mod Pathol. 2010;23(6):814-823.
  3. Pentheroudakis G, Pavlidis N, Fountzilas G, et al. Novel microRNA-based assay demonstrates 92% agreement with diagnosis based on clinicopathologic and management data in a cohort of patients with carcinoma of unknown primary. Mol Cancer. 2013;12(1):57.
Evidence

RosettaGX Cancer Origin is a product of more than 5 years of research analyzing hundreds of tumor samples. This test has been developed using rigorous methodology and was validated using an independent blinded set of samples.

External validation studies conducted by world-renowned CUP centers of excellence have confirmed the high level of accuracy of the RosettaGX microRNA profiling test.

RosettaGX Cancer Origin outperformed other tests, such as mRNA-based assays, showing the highest concordance with leading clinicopathological evaluations.1,3

In addition, an inter-lab reproducibility study of 179 samples verified the robust and reproducible nature of the test with 98% agreement between labs.1

Read Studies About Cancer Origin

Meiri E, Mueller WC, Rosenwald S, et al. A Second-Generation microRNA-Based Assay for Diagnosing Tumor Tissue Origin. Oncologist. 2012 May 22

Greco F. A, Oien K, Erlander M, et al. Cancer of unknown primary: progress in the search for improved and rapid diagnosis leading toward superior patient outcomes. Ann Oncol. 2012 23(2): 298-304.

Chajut A, Aharonov R, Rosenwald S, et al. A second generation microRNA-based assay for diagnosing tumor tissue origin. ASCO 2011.

Varadhachary G, Spector Y, Abbruzzese JL, et al. Prospective gene signature study using microRNA to predict the tissue of origin (ToO) in patients with cancer of the unknown primary (CUP). Clin Cancer Res. 2011 17(12):4063-70.

Mueller W, Spector Y, Edmondson T, et al. Accurate classification of metastatic brain tumors using a novel microRNA-based test. Oncologist. 2011 16(2):165-174.

References

  1. Meiri E, Mueller W, Rosenwald S, et al. A Second-Generation microRNA-Based Assay for Diagnosing Tumor Tissue Origin. Oncologist. 2012;17(6):801-812.
  2. Rosenwald S, Gilad S, Benjamin S, et al. Validation of a microRNA based qRT-PCR test for accurate identification of tumor tissue origin. Mod Pathol. 2010;23(6):814-823.
  3. Pentheroudakis G, Pavlidis N, Fountzilas G, et al. Novel microRNA-based assay demonstrates 92% agreement with diagnosis based on clinicopathologic and management data in a cohort of patients with carcinoma of unknown primary. Mol Cancer. 2013;12(1):57.