OncoMate® MSI Dx Analysis Software Technical Manual
Instructions for Use of Product(s)
Literature # TM680
Intended use statement for use as a companion diagnostic test to identify patients with endometrial carcinoma who may benefit from treatment with KEYTRUDA® (pembrolizumab) in combination with LENVIMA® (lenvatinib)
The OncoMate® MSI Dx Analysis System (Cat.# MD2140) is a qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in five microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) for the identification of microsatellite instability (MSI) using DNA obtained from formalin-fixed, paraffin-embedded (FFPE) endometrial carcinoma tissue specimens, and DNA isolated from matched normal FFPE specimen or whole blood. The OncoMate® MSI Dx Analysis System (Cat.# MD2140) is for use with the Applied Biosystems® 3500 Dx Genetic Analyzer and OncoMate® MSI Dx Analysis Software (Cat.# MD4160).
The OncoMate® MSI Dx Analysis System is indicated for use as a companion diagnostic test to identify patients with microsatellite stable (MSS; defined as not MSI-high [not MSI-H]) endometrial carcinoma who may benefit from treatment with KEYTRUDA® (pembrolizumab) in combination with LENVIMA® (lenvatinib) in accordance with the approved therapeutic product labeling.
This technical manual provides information on specific functions and capabilities of the OncoMate® MSI Dx Analysis Software. It is not intended to be a step-by-step guide to using the analysis software. Consult the OncoMate® MSI Dx Analysis System Technical Manual #TM543 for step-by-step instructions to analyze and interpret data, and additional information about assay requirements and use.
Cat.# MD2140 is available in the United States, American Samoa, Guam, Puerto Rico, and the US Virgin Islands.
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