Dx – Ignyta Trailblaze™ Molecular Diagnostic Testing

Our Dx efforts aim to pair our precision therapeutic candidates with biomarker-based companion diagnostics that rapidly identify the patients most likely to benefit from the therapies we develop.

We currently offer companion diagnostic tests to identify candidates for our targeted oncology pipeline of investigational drugs.

Trailblaze Pharos™ Diagnostic Suite

With the launch of Trailblaze Pharos™, we are now able to identify actionable gene fusions in solid tumors that may qualify for enrollment in the STARTRK-2 cancer clinical trial.

For more information on NTRK, ROS1, and ALK molecular diagnostic testing for enrollment in the STARTRK-2 study, visit our Trailblaze Pharos Diagnostic Testing page.

Molecular diagnostic testing, and why it's crucial for patients diagnosed with cancer.
How molecular diagnostic testing identifies patients for whom Ignyta's targeted therapies can do the most good.
Molecular screening matches patients with precision cancer therapies suited their particular disease.

NGS – Next-Generation Sequencing

Ignyta’s Trailblaze™ diagnostic programs leverage both Immunohistochemistry (IHC) screening and Next-Generation Sequencing (NGS) to identify tumors that may respond to entrectinib. First, IHC is used to measure protein expression levels for NTRK1, NTRK2, NTRK3, ROS1, and ALK. Then the presence of a gene rearrangement of interest is confirmed by NGS. Our clear and concise output report puts actionable results in your hands.

For more information, click below:
CLIA ID: 05D2086873

Determine the presence of gene rearrangements in NTRK1, NTRK2, NTRK3, ROS1, or ALK, which may indicate eligibility for tyrosine kinase inhibitor (TKI) therapy.
A chromosomal rearrangement (including fusion, insertion, and deletion) that results in a constitutively active chimeric protein can lead to oncogenic activation of receptor tyrosine kinases. These oncoproteins are established as drivers of malignancy and as potential therapeutic targets in a broad range of solid and hematological cancers.1-3

Ignyta’s NGS assay has been analytically validated and serves as a companion to clinical study NCT02097810, a Phase I/IIa Study of Oral Entrectinib (RXDX-101) in Adult Patients with Locally Advanced or Metastatic Cancer and other related clinical studies of entrectinib. For more information on Ignyta NTRK, ROS1, and ALK cancer clinical trials, visit https://www.startrktrials.com.

Preferred Specimen: FFPE tissue block
Acceptable Specimen: Four (4) 10µm unstained tissue sections mounted on positively charged slides and 1 H&E stained slide

Transport: Ambient temperature
Methodology: Next-Generation Sequencing
Performed: Mon-Fri
Reported: 2 weeks

Contact us to learn more about ordering for the STARTRK-2 Trial

Phone: (toll free) 844-446-9821
Ignyta, Inc.
4545 Towne Centre Ct.
San Diego, CA 92121



  1. De Braud, F.G et al. (2015) “Alka-372-001: First-in-human, phase I study of entrectinib – an oral pan-trk, ROS1, and ALK inhibitor – in patients with advanced solid tumors with relevant molecular alterations.” J. Clin Oncol 33, (suppl; abstr 2502).
  2. Patel, M.R. et al (2015) “STARTRK-1: Phase I/IIa study of entrectinib, an oral Pan-Trk, ROS1, and ALK inhibitor, in patients with advanced solid tumors with relevant molecular alterations.” J Clin Oncol 33, (suppl; abstr 2596)
  3. Shaw, A., et al. (2013) Tyrosine kinase gene rearrangements in epithelial malignancies. Nature Reviews Cancer. 13, 772-787

The Rx/Dx Advantage

Decoding the underlying causes of cancer is an evolving field, with much at stake from all sides. Learn more about Ignyta’s Rx/Dx Advantage and how we’re working with healthcare providers to change cancer treatment and care.

Ignyta Scientific Presentations

A database of Ignyta’s clinical, scientific, and technical data on precision therapeutic candidates and diagnostic tests. See Ignyta’s Scientific and Clinical Presentations.