The Complex Issue

Patients with recurrent or advanced disease historically have had limited treatment options. Mismatch Repair (MMR) is a molecular mechanism that functions to repair certain errors that occur during DNA replication. Deficiency of this mechanism is most common in endometrial cancer. Confirming MMR status can, therefore, provide valuable information to determine eligibility for anti-PD1 immunotherapy.

90,000 women die globally from endometrial carcinoma each year1

Endometrial Carcinoma accounts for 90% of all Uterine cancers in the US2

The Breakthrough Solution - MMR RxDx Panel

First FDA-approved immunohistochemical companion diagnostic test to identify endometrial cancer patients eligible for immunotherapy

Identification of patients eligible for treatment with JEMPERLI (dostarlimab-gxly) in accordance with the approved therapeutic product labeling

Intended Use

 

The VENTANA MMR RxDX Panel is intended for the qualitative assessment of DNA mismatch repair proteins in endometrial tumor tissue. Determination of MMR status is based on a panel of four IHC stains scored by Laboratory Medicine Consultants (LMC) pathologists following the FDA-approved protocol. Endometrial cancers determined to be dMMR by Roche Tissue Diagnostics assay may be eligible for treatment with JEMPERLI (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody approved by the FDA for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

For more information on how to order this test
please contact LMC Pathology Services at 702.732.3441

References:

1Bray F, Ferlay J, et al, Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. (2018) 68:394–424. 10.3322/caac.21492

2American Cancer Society, https://www.cancer.org/cancer/endometrial-cancer/about/key-statistics.html