Microsatellite Instability (MSI) Analysis by PCR

Formalin-fixed, paraffin-embedded tissue blocks; fixed in 10% neutral-buffered formalin for at least 6 hours, and not more than 48 hours. Tissue should be prepared in sections between 4 and 6 microns thick. Cell blocks and cytospins made from FNA (fine needle aspirates). Cytopathology ThinPrep slides with morphologic correlation. EDTA decal specimens are accepted.

Keytruda (pembrolizumab) was FDA approved for the treatment of both adult and pediatric patients who have unresectable or metastatic, MSI-high or mismatch repair deficient (dMMR) solid tumors that have progressed after prior treatment, and who have no satisfactory alternative treatment options. MSI is clinically useful to identify patients with hereditary non-polyposis colorectal cancer (HNPCC)/Lynch syndrome caused by germline mutations of mismatch repair genes.

Copy of the referring client's requisition form and pathology report to accompany specimen.

Room temperature or refrigerated. Ship in cooled container during summer months.

Tissue not verified for the presence of tumor and specimens fixed in fixatives other than formalin are not acceptable. Samples <20% tumor burden will not be tested, as false negative results cannot be ruled out. Surgical pathology report not included. Only specimens decalcified in EDTA will be accepted for molecular testing. Testing may be cancelled if a sufficient amount of DNA cannot be extracted.

2 years DNA and raw data, 10 years FFPE

"Only tissue that is clearly invasive carcinoma (established by histopathologic criteria) should be tested. Selection of tissue for the PCR assay should be performed by a pathologist.

This test was developed and its performance characteristics determined by CellNetix Labs LLC. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. CellNetix is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing."