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OncoExTra

The OncoExTra® test helps physicians understand changes to a patient's genomic profile by providing a more complete molecular picture of advanced, metastatic, refractory, relapsed, or recurrent solid tumors. Knowing this information can help patients and physicians make informed choices when considering therapeutic treatment plans.

 

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THE FULL GENOMIC STORY REQUIRES
MORE THAN DNA ALONE

  • Ultra-Comprehensive Genomic Profiling
  • Patient Matched Tumor-Normal Sequencing
  • Clinically Actionable

  • Ultra-Comprehensive Genomic Profiling

    Interrogating both DNA and RNA, the OncoExtra® test provides ultra-comprehensive genomic profiling that thoroughly detects clinically actionable mutations and fusions.1 It delivers the all-encompassing genomic insights of whole-exome (DNA) and whole transcriptome (RNA) sequencing, highlighting key information that is critical to personalized cancer care.

  • Patient Matched Tumor-Normal Sequencing

    The OncoExTra test utilizes patient-matched tumor-normal sequencing to further refine therapy selection. Patient-matched tumor-normal sequencing compares the sequence of genes in both somatic and germline DNA. This approach improves estimates of tumor mutational load and may better predict clinical benefit to immunotherapy with fewer false positives.2-4

  • Clinically Actionable

    In a clinical utilization study, 83.9% of OncoExTra test reports showed ≥1 clinically actionable variant.1*† The test's easy-to-interpret report highlights the most actionable insights for timely, shared decision-making:

    • Mutations and fusions associated with FDA-approved therapies††
    • Immuno-oncology signatures (TMB/MSI) support personalized therapy selection
    • Clinical trial options to help inform next steps

*Retrospective analysis of 1509 clinical reports, of which 1261 included both DNA and RNA profiling. OncoExTra RNA findings detected variants in 5.9% [75/1261] of samples vs 3.5% [44/1261] in DNA analysis.1

†Clinically actionable variants are defined as variants that are associated with available therapies or clinical trial enrollment for a specific somatic variant identified in a patient’s tumor.1

††The OncoExTra test is not an FDA-cleared or -approved IVD device or companion diagnostic for the referenced biomarkers and FDA-approved therapies.1

1. White T, Szelinger S, LoBello J, et al. Analytic validation and clinical utilization of the comprehensive genomic profiling test, GEM ExTra®. Oncotarget. 2021;12(8):726-739.

2. Goodman AM, Kato S, Bazhenova L, et al. Tumor mutational burden as an independent predictor of response to immunotherapy in diverse cancers. Mol Cancer Ther. 2017;16(11):2598-2608.

3. Bonneville R, Krook MA, Kautto EA, et al. Landscape of microsatellite instability across 39 cancer types. JCO Precis Oncol. 2017;2017:PO.17.0073.

4. Jones S, Anagnostou V, Lytle K, et al. Personalized genomic analyses for cancer mutation discovery and interpretation. Sci Transl Med. 2015;7(283):283ra53.

The OncoExTra test was developed, and the performance characteristics validated by Genomic Health, Inc., a wholly-owned subsidiary of Exact Sciences Corporation following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. The OncoExTra test is performed at the Genomic Health Phoenix clinical laboratory. Exact Sciences clinical laboratories are accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing. This tests has not been cleared or approved by the US Food and Drug Administration or other notified regulatory authority.