Trailblaze Pharos™   Diagnostic Programs:

As part of the Trailblaze® molecular diagnostics program, Ignyta is now offering Trailblaze Pharos, a suite of molecular diagnostic assays and services, including proprietary companion diagnostic tests, to accompany its molecularly targeted oncology programs.

Trailblaze Pharos is a multiplex assay for identifying actionable fusions in NTRK1, NTRK2, NTRK3, ROS1, and ALK genes, resulting in solid tumors that can be treated with entrectinib, to support testing for the STARTRK-2 clinical trial.

Tests included in the Trailblaze Pharos series are also available individually, including:

The Ignyta Trailblaze Pharos diagnostic testing assay

NTRK testing on FFPE specimens

CLIA ID: 05D2086873

Recommended Ordering Criteria:

Determine the presence of an NTRK1 gene fusion or deletion, which may indicate eligibility for the STARTRK-2 trial of entrectinib.

Up to 3% of non-small cell lung cancers have been found to harbor NTRK1 gene fusions.1 Malignancies driven by constitutively activated fusion kinases can be susceptible to attenuation by small molecule inhibitors.2 NTRK1 fusions have also been observed in melanoma, papillary thyroid cancer, cholangiocarcinoma, lung cancer, glioblastoma, colorectal cancer, and pediatric high-grade glioma.3,4

Ignyta’s NTRK1 assay is being performed in support of clinical study NCT02097810, a phase I/IIa Study of Oral RXDX-101 (entrectinib) in Adult Patients With Locally Advanced or Metastatic Cancer; the first of the “Studies of Tumor Alterations Responsive to Targeting Receptor Kinases” (STARTRK-1).

Specimen Requirements:

  • Preferred Specimen: FFPE tissue block
  • Acceptable Specimen: 3-4 unstained slides and 1 H&E stained slide, 4-5µm thick tissue sections on positively charged slides
  • For more information on specimen requirements and handling, click here.

Transport: Ambient temperature

  • Performed: Mon-Fri
  • Reported: 5-7 days

References:

  1. Vaishnavi, A., et al. (2013). Oncogenic and drug sensitive NTRK1 rearrangements in lung cancer. Nat Med. 19(11), 1469-1472.
  2. Shaw, A., et al. (2013). Tyrosine kinase gene rearrangements in epithelial malignancies. Nat Rev Cancer. 13(11), 772-787.
  3. Wiesner, T. et al. (2014). Kinase fusions are frequent in Spitz tumours and spitzoid melanomas. Nat Commun. 5:3116
  4. Stransky N., et al. (2014). The landscape of kinase fusions in cancer. Nat Commun. 5:4846.

ROS1 testing on FFPE specimens

CLIA ID: 05D2086873

Ordering Recommendation:

Determine the presence of ROS1 rearrangement which may indicate eligibility for the STARTRK-2 trial of entrectinib.

Non-small cell lung cancers (NSCLC) have been found to harbor ROS1 fusions in approximately 1-2% of cases.1 ROS1 rearrangements have also been observed in glioblastoma, cholangiocarcinoma, ovarian cancer, gastric cancer, and colorectal cancer.3,4 Ignyta ROS1 testing utilizes a probe construction that is arranged to identify known ROS1 rearrangements, as well as the GOPC (FIG) interstitial deletion.4

Ignyta’s ROS1 assay is being performed in support of 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.

Specimen Requirements:

  • Preferred Specimen: FFPE tissue block
  • Acceptable Specimen: 3-4 unstained slides and 1 H&E stained slide, 4-5µm thick tissue sections on positively charged slides
  • For more information on specimen requirements and handling, click here.

Transport: Ambient temperature

  • Performed: Mon-Fri
  • Reported: 5-7 days

References:

  1. Davies, K., et al. (2012) Identifying and Targeting ROS1 Gene Fusions in Non-Small Cell Lung Cancer. Clin Cancer Res. 18, 4570-4579.
  2. Shaw, A., et al. (2013) Tyrosine kinase gene rearrangements in epithelial malignancies. Nature Reviews Cancer. 13, 772-787.
  3. Davies, K., & Doebele, R. (2013) Molecular Pathways: ROS1 Fusion Proteins in Cancer. Clin Cancer Res. 19, 4040-4045.
  4. Charest, A., et al. (2003) Fusion of FIG to the Receptor Tyrosine Kinase ROS in a Glioblastoma with an Interstitial del(6)(q21q21). Genes, Chromosomes & Cancer. 37, 58-71.

ALK testing on FFPE specimens

CLIA ID No. 05D2086873

Ordering Recommendation:

Determine the presence of anaplastic lymphoma kinase (ALK) gene rearrangement, which may indicate eligibility for the STARTRK-2 trial of entrectinib.

Rearrangements of the ALK gene on chromosome 2 have been identified in several types of cancer, including an estimated 3-7% of non-small-cell lung cancer (NSCLC).2,3 ALK rearrangements have also been associated with anaplastic large-cell lymphoma, neuroblastoma, inflammatory myofibroblastic tumors, breast cancer, colorectal cancer, esophageal cancer, renal cell cancer, renal medullary cancer, diffuse B-cell lymphoma, and anaplastic thyroid carcinoma.2,3

Ignyta’s ALK assay is being performed in support of clinical study NCT02097810, a phase I/IIa Study of Oral entrectinib (formerly called RXDX-101) in Adult Patients with Locally Advanced or Metastatic Cancer, which is the first of the “Studies Targeting ALK, ROS1, and/or TRKA/B/C” (STARTRK-1), as well as other related clinical studies of entrectinib.

Specimen Requirements:

  • Preferred specimen: FFPE tissue block
  • Acceptable specimen: 3-4 unstained slides and 1 H&E stained slide, 4-5µm thick tissue sections on positively charged slides
  • For more information on specimen requirements and handling, click here.

Transport: Ambient temperature

  • Ignyta uses an FDA-approved break-apart probe set.
  • Performed: Mon-Fri
  • Reported: 5-7 days

References:

  1. Leighl, N, et al. (2014). Molecular Testing for Selection of Patients With Lung Cancer for Epidermal Growth Factor Receptor and Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors: American Society of Clinical Oncology Endorsement of the College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology Guideline. J Clin Onc. 2014:3673–3679;
  2. Shaw, A, et al. (2013). Tyrosine kinase gene rearrangements in epithelial malignancies. Nature Reviews Cancer. Advance online publication. doi: 10.1038/nrc3612
  3. Minoo, P., & Wang, H (2012). ALK-immunoreactive neoplasms. Int J Clin Exp Pathol 2012;5(5):397-410.

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

clientservices@ignyta.com
Phone: 858-255-5950
Toll free: 1-844-446-9821
Ignyta, Inc.
4545 Towne Centre Ct.
San Diego, CA 92121

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