Solid TumorSEQ™

Solid TumorSEQ™ is a tissue-based, comprehensive genomic profiling test that evaluates 523 genes and delivers personalized genomic information on a wide variety of cancer-related biomarkers including clinically actionable genes and genomic signatures for any patient with a solid tumor. Actionability is defined as information that might aid a clinician in diagnosis, prognosis, and/or treatment strategy for a patient.¹

This precision-medicine approach can help healthcare providers identify treatment strategies and can inform on clinical trial availability and eligibility based on the genomic profile of that patient’s tumor. Many FDA-approved therapies,² including targeted therapies, immunotherapy, and clinical trial eligibility, rely on accurate detection and reporting of mutations in clinically relevant genes in a timely manner to improve patient outcomes. Tissue-based, comprehensive genomic profiling through next-generation sequencing is useful for evaluating many genomic biomarkers simultaneously from a single sample, resulting in tissue conservation with quicker delivery of results than multiple iterative testing strategies.

Any significant genomic findings are annotated according to Association for Molecular Pathology (AMP) reporting guidelines. A board-certified Quest clinician will review and validate the results and prepare a report for the treating physician.⁴

Genomic testing of a patient’s tumor allows for some patients to benefit from treatments that target cancer cells containing specific genetic mutations. Guidelines exist for using results from tumor genetic testing for selection of FDA-approved therapies. Genomic panel testing allows for diverse data generation, which enables enrollment in specific clinical trials and adaptation of treatment strategies.^2,3,4,5

Clinical trial information provided in this test is solely for informational purposes for the physician and does not constitute any endorsement or a recommendation for enrollment of patients in any trial by Quest Diagnostics, its affiliates, or its employees.

Solid TumorSEQ™ was developed for patients with a solid tumor when diagnosis, prognosis, or treatment selection could be informed by the presence of genomic variants and microsatellite instability/tumor mutational burden (MSI/TMB) status. Clinical situations where this panel may be helpful include the following:

• Patients with locally advanced or metastatic disease at presentation
• Patients harboring tumors with no actionable mutations found by guideline-recommended testing
• Patients with recurrent or metastatic disease that have progressed through all standard-of-care options
• Patients with certain rare tumor types
• Patients with tumors of unknown primary origin

Solid TumorSEQ™ is a 523-gene comprehensive genomic profiling test that uses next-generation sequencing to detect mutations present in DNA and RNA extracted from formalin-fixed, paraffin embedded (FFPE) tissue sections of solid tumors. The test is designed to detect single-nucleotide variants (SNVs), small insertions/deletions, copy number variants, gene fusions, as well as splice site variants in a select group of genes. Microsatellite instability (MSI) and tumor mutational burden (TMB) are also evaluated. 

• Preferred: Room-temperature, formalin-fixed, paraffin-embedded (FFPE) tissue block containing 200 mm² of tumor tissue with ≥20% tumor content
• Minimum: 10 mm² of tumor tissue with ≥10% tumor content

Yes. The LiquidSEQ™ panel may be considered (test code 14308) when tissue is limited or unavailable for tissue-based genomic profiling. LiquidSEQ™ is a blood-based, comprehensive genomic profiling test that evaluates 523 genes; blood samples can contain DNA shed from a patient’s tumor specimen that may be helpful in guiding cancer treatment. For patients who have insufficient tumor tissue or are unable to have solid-tumor testing, liquid biopsy is an alternative test to assess eligibility for targeted therapies.

Additionally, a reflex test code is available that includes LiquidSEQ™ with reflex to Solid TumorSEQ™ (test code 14343) in the event LiquidSEQ™ yields insufficient nucleic acid to perform the test or if LiquidSEQ™ yields no actionable mutations and tissue will be available to perform Solid TumorSEQ™ .