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| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
Tumor Mutation Burden
Test Code12354
Preferred Specimen
**This test is not available for New York or Rhode Island
patient testing.**
Instructions:
Do not freeze. Do not reject.
Submit in sterile biohazard plastic bag at room temperature
or on ice pack in summer. Specimen to be tested should
contain a minimum of 10 percent tumor nuclei.
All specimens must be accompanied with Pathology report.
All FFPE specimens will be examined by a pathologist for
confirmation and adequacy. Macrodissection if warranted is
performed in the lab.
Reject Criteria:
Decalcified tissue specimen
PREFERRED
5-10 slides (10-micron sections) for resection or surgical
specimens with H&E slide in slide holder, room temperature
or refrigerated (cold packs)
--or--
10-20 slides (10-micron sections) for core needle biopsies
in slide holder, room temperature or refrigerated (cold
packs)
--or--
ACCEPTABLE
Paraffin-embedded tissue block accompanied by a circled H&E
slide indicating the area to be examined, room temperature
or refrigerated (cold packs)
RT: Preferred
Refrigerated (cold packs): Acceptable
Frozen: Unacceptable
patient testing.**
Instructions:
Do not freeze. Do not reject.
Submit in sterile biohazard plastic bag at room temperature
or on ice pack in summer. Specimen to be tested should
contain a minimum of 10 percent tumor nuclei.
All specimens must be accompanied with Pathology report.
All FFPE specimens will be examined by a pathologist for
confirmation and adequacy. Macrodissection if warranted is
performed in the lab.
Reject Criteria:
Decalcified tissue specimen
PREFERRED
5-10 slides (10-micron sections) for resection or surgical
specimens with H&E slide in slide holder, room temperature
or refrigerated (cold packs)
--or--
10-20 slides (10-micron sections) for core needle biopsies
in slide holder, room temperature or refrigerated (cold
packs)
--or--
ACCEPTABLE
Paraffin-embedded tissue block accompanied by a circled H&E
slide indicating the area to be examined, room temperature
or refrigerated (cold packs)
RT: Preferred
Refrigerated (cold packs): Acceptable
Frozen: Unacceptable
Methodology
Next Generation Sequencing
Setup Schedule
Monday-Sunday Morning
Report available: 11 Days
Report available: 11 Days
Reference Range
See Laboratory Report
Clinical Significance
The Tumor Mutation Burden (TMB) assay is intended to be
used as an aid in predicting response to immuno-oncology
therapies among patients with advanced solid tumor
malignancies. Higher somatic TMB has been associated with
improved survival in patients receiving immune checkpoint
inhibitor therapy across a wide variety of cancer types.
The FDA has approved Pembrolizumab therapy as treatment
for patients with metastatic solid tumors using TMB as a
biomarker. Clinical trials may be available for patients
with high TMB in certain solid tumors.
used as an aid in predicting response to immuno-oncology
therapies among patients with advanced solid tumor
malignancies. Higher somatic TMB has been associated with
improved survival in patients receiving immune checkpoint
inhibitor therapy across a wide variety of cancer types.
The FDA has approved Pembrolizumab therapy as treatment
for patients with metastatic solid tumors using TMB as a
biomarker. Clinical trials may be available for patients
with high TMB in certain solid tumors.
