Laboratory Developed Test
Available in the US only
How may OncoSIGNal support treatment strategies?
Identifying actionable tumor-driving cell signaling pathways in breast cancer
The OncoSIGNal Laboratory Developed Test (LDT) reports a new type of biomarker to identify the tumor-driving cell signaling pathways. Mutations or aberrations in the tumor DNA or changes in the tumor micro-environment can cause aberrant activation of cell signaling pathways driving tumor growth. Activation of signaling pathways is associated with response or resistance to drugs. The pathway activity profile can be used to guide therapy with targeted drugs inhibiting the pathway activity.
The OncoSIGNal LDT quantitatively measures functional activity of potentially tumor-driving cell signaling pathways in a patient’s tumor tissue sample. Activity scores for the ER, AR, PI3K, MAPK, Hedgehog, Notch and TGFß pathways are reported in relation to reference ranges indicating which pathways have a high or low activity and may be addressed with targeted drugs. The LDT has been validated for use in breast cancer.
About the OncoSIGNal LDT
The LDT is validated for FFPE breast cancer tissue and uses RT-qPCR to determine the mRNA expression of selected target genes of the pathway transcription factors, and a number of housekeeping genes for normalization and quality control. Computational algorithms translate the mRNA expression into an activity score for each pathway on a scale of 0-100. Reference ranges indicate the normal activity level of each of the pathways in breast tissue and support interpretation of patient pathway scores.
Tissue requierements
- FFPE tissue from breast cancer, ≥50% tumor cells
- Tissue blocks or tissue slides
How may OncoSIGNal support treatment strategies?
Patients failing hormonal suppression
Recurrent breast carcinoma following hormonal suppression, local recurrence or metastasis, with a sample from time of progression.
Patients with low ER / PR IHC
Confirm that endocrine therapy will be effective, e.g. for low positive ER and/or low positive PR IHC cases.
Triple-negative breast cancer
Triple-negative breast cancer cases at time of diagnosis or progression to identify options for targeted therapy.
Workflow
Patient breast cancer
tissue (FFPE)
qPCR measuring mRNA expression of selected pathway target genes
Computational algorithms determining pathway activity scores
Patient report indicating actionable
tumor-driving pathways
How to order
OncoSIGNal LDT is available in the US through InnoSIGN’s CLIA laboratory.
- Please reach out to oncosignal@innosignbio.com to discuss your request.
- Download the Test Requisition Form, instructions for sample preparation and shipment.
- Complete the Test Requisition Form and send your samples to the InnoSIGN CLIA lab, Mason, OH.
- Pathway results and clinical interpretation are presented in a comprehensive patient report.
Robert Babkowski, MD – CLIA Lab Medical Director
Sandra Gunselman – Director CLIA Lab Operations
Customer Service Information
InnoSIGN Inc.
5155 Financial Way, Suite 17
45040 Mason, OH, US
CLIA ID: 36D2277604
E-mail: customersupport@innosignbio.com
T: 800-686-0844 (toll-free)
Opening hours: Mon to Sat from 9:00am-5:00pm EST