Molecular characterization featuring our proprietary Trailblaze Pharos™ assay
What does this mean for Oncologists and other Health Care Providers?
Our companion diagnostics approach pairs the Trailblaze Pharos™ comprehensive diagnostic assay with a promising investigational precision therapy for trial participants.
It is provided at no-cost to ordering physicians.
Expand your clinical toolkit to include the Trailblaze Pharos™ molecular test.
More about Trailblaze Pharos™ Two-Step Cancer Diagnostics
Specimens undergo Next-Generation Sequencing (using a custom Archer® FusionPlex® panel) to identify whether rearrangements in the genes of interest are present.1
Results are communicated in a clear format that takes the guesswork out of interpretation.
A detailed report will be provided to the ordering physician within two to three weeks of sample receipt.
This rigorous screening step streamlines the decision making process by identifying those patients who may be eligible for enrollment in the STARTRK-2 trial and potentially derive benefit from investigational entrectinib treatment.
Ignyta covers the costs of diagnostic testing for all patient specimens; you can utilize this technology at no-cost to your practice. Our logistics team will:
Provide packaging and shipping materials
Retrieve existing biopsy samples
Provide the diagnostic result within two to three weeks of receipt of the tissue specimen at Ignyta's CAP-accredited central diagnostics lab
View a sample Trailblaze® Report
Identifying information: The Ignyta Diagnostic Lab is fully CAP, HIPAA and QSR compliant.
Clinical Data: Previous information about the patient's disease is summarized here for reference at-a-glance.
Result: Results of molecular and genetic testing for cancer biomarkers are presented in a clear, unbiased way. This format empowers the ordering physician to make a confident decision to proceed with continuing the enrollment process.
Ignyta has established multiple trial locations across the globe.
Upon receipt, please ensure that you use the international air waybill that will be included in your ship kit. It is important that you complete the required information, write clearly and sign the waybill.
Please ensure a commercial invoice is included per country and local carrier requirements.
Specimen Requirements and Handling
The quality of laboratory results is highly dependent upon proper specimen collection and handling. Listed below are specimen requirements and handling procedures for tests processed by Ignyta.
|Specimen Type1-3||Requirements for IHC||Requirements for NGS||Storage/Transport5|
|Formalin Fixed Paraffin Embedded Tissue (Blocks)||Preferred specimen.||Preferred specimen.||Room Temperature.Use cold pack for transport.|
|Formalin Fixed Paraffin Embedded Unstained Slides||4µm thick tissue sections on positively charged slides. 2 slides per assay||10μm thick tissue sections on positively charged slides. 4 slides per assay and 1 H&E stained slide.||Room Temperature. Use cold pack for transport.|
If a stained H&E cannot be provided, please send one unstained slide cut at 4μm thickness for H&E staining
- Two (2) patient identifiers are required on all specimens. Please include date of collection.
- Specimens should be fixed in 10% Neutral Buffered Formalin (NBF) for a minimum of 6 hours. Do not use zinc or B5 fixatives.
- Paraffin embedded tissue that has been decalcified is not appropriate for IHC or NGS.
- Unstained slides should be received within 6 weeks of cutting.
- Cold pack should not be placed in direct contact with the specimen.
Place specimens in an Ignyta Pathology Specimen Shipping kit. Slides should be enclosed in a plastic slide mailer. Enclose a completed test requisition form and a copy of the pathology report.
Shipping kits may be obtained from Client Services
QUESTIONS? EMAIL IGNYTA CLIENT SERVICES AT: email@example.com
1 Murphy et al. Appl Immunohistochem Mol Morphol 2016
This test was developed and its performance characteristics determined by Ignyta, Inc. It has not been cleared or approved by the FDA. The laboratory is regulated under the CLIA as qualified to perform high-complexity testing.