OncoMate® MSI Dx Analysis System Technical Manual
Instructions for Use of Product(s)
MD2140
Literature # TM543
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 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 is for use with the Applied Biosystems® 3500 Dx Genetic Analyzer and OncoMate® MSI Dx Analysis Software.
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.
Intended use statement for use as an aid to identify candidates for further testing for Lynch Syndrome with colorectal cancers
The OncoMate® MSI Dx Analysis System 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) using matched tumor and normal DNA obtained from formalin fixed, paraffin-embedded (FFPE) colorectal tissue sections. The OncoMate® MSI Dx Analysis System is for use with the Applied Biosystems® 3500 Dx Genetic Analyzer and OncoMate® MSI Dx Interpretive Software.
The OncoMate® MSI Dx Analysis System is indicated in patients diagnosed with colorectal cancer (CRC) to detect microsatellite instability (MSI) as an aid in the identification of probable Lynch syndrome to help identify patients that would benefit from additional genetic testing to diagnose Lynch syndrome. Results from the OncoMate® MSI Dx Analysis System should be interpreted by healthcare professionals in conjunction with other clinical findings, family history, and other laboratory data.
Cat.# MD2140 is available in the United States, American Samoa, Guam, Puerto Rico, and the US Virgin Islands.
Summary of Changes
The following changes were made to the Rev1 version of this document:
1. Specified Part 1 (Sections 1–13) as a companion diagnostic test protocol.
2. Replaced Intended Use text in Section 1.5.
3. Edited Sections 1.6, 1.7, 3.1, 3.5, 3.6.1, 3.6.2, 3.7.1, 4.2, 4.5, 4.9, 5.4 and 11.
4. Added Note to Section 4.
5. Updated Figure 1.
6. Added new Section 9.
7. Added the Lynch syndrome candidate protocol as Part 2 (Sections 14–26), renumbering figures and tables.
8. Made minor text edits.
Rev1