MayoComplete Bladder and Prostate Cancer Panel, Next-Generation Sequencing, Tumor
Use
The test is primarily used for assessing if patients with bladder or prostate cancer will respond to targeted therapy. It includes the assessment of microsatellite instability, which is crucial for determining the efficacy of immunotherapy in solid tumors. This test identifies somatic mutations in a curated list of 39 genes relevant for the clinical management of prostate or bladder cancer, and these data can aid in assessing prognosis and guiding treatment. The results can also help determine clinical trial eligibility for patients with alterations in genes not amenable to current FDA-approved targeted therapies.
Special Instructions
A pathology report containing the patient name and block number must accompany the specimen. The specified tumor area and nuclei percentage are crucial for test validity. Extensive notes about fixation and slide handling emphasize not to use decalcified samples, and that the unused slides or cytology samples will not be returned.
Limitations
The test does not determine germline alterations, nor does it detect multi-exon deletions, duplications, larger copy number variants, copy-neutral loss of heterozygosity, or certain epigenetic modifications. It cannot differentiate between PMS2 and its homologous pseudogene PMS2CL for certain variants. A negative test does not eliminate the possibility of a variant undetectable within the assay's sensitivity limits. For patients with >20% tumor content, the sensitivity for sequence reportable alterations is at 5% mutant allele frequency with 500X minimum coverage.
New York Approved
Methodology
NGS (Targeted)
Biomarkers
LOINC Codes
- 105589-6
- 82939-0
- 69047-9
- 48767-8
- 31208-2
- 80398-1
- 85069-3
- 62364-5
- 18771-6
Result Turnaround Time
12-20 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Minimum amount of tumor area: tissue 36 mm(2)
Collection Instructions
Submit a formalin-fixed, paraffin-embedded tissue block with acceptable amount of tumor tissue.
Causes for Rejection
Improper fixation or handling.