MSH6 Microsatellite Instability, technical only
Companion Diagnostic
MSH6 Microsatellite Instability, technical only is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
MutS Homologue 6 (MSH6) is a mismatch repair (MMR) protein. Deficiencies in MSH6 result in microsatellite instability (MSI) in cancers such as colorectal and endometrial. This antibody is part of the Ventana MMR RxDx FDA-approved companion diagnostic. Technical component only. Pathologist read not included.
Special Instructions
Fresh Tissues: Specimens may be fixed in formalin for 24-72 hours by collection sites, then transferred to 70% ethanol and stored at 2-8°C for longer term storage if needed. Samples must be tested 3 months after placing in ethanol. Unstained slides: Positively charged glass slides required to prevent background staining and prevent tissue loss. Slides should be left unbaked.
Limitations
This is a technical component only and does not include a pathologist read. The performance and limitations of the assay are subject to changes based on specific protocol requirements of biopharma studies. The test is strictly for clinical use and not intended for other applications unless specified in the contract.
FDA ApprovedCompanion Diagnostic
Methodology
Immunoassay (IHC)
Biomarkers
Result Turnaround Time
2 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (Fixed (Non-FFPE))
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Fixative should be at a 20:1 fixative to tissue ratio, 10% neutral buffered formalin (NBF) for 6-72 hours (48-72 hours PREFERRED).
Storage Instructions
Store at 15°C to 25°C.
Causes for Rejection
Specimens must be fixed in 10% NBF or B plus. All other fixatives will be rejected.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | ≤ 72 Hours |