New Companion Diagnostic to qualify Endometrial Cancer Patients for Immunotherapy:

The complex issue:

90,000 women die globally from endometrial carcinoma each year.1 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.

The breakthrough solution:

The VENTANA MMR RxDX Panel is the first FDA-approved immunohistochemical (IHC) companion diagnostic (CDx) to identify endometrial cancer patients eligible for immunotherapy. It 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).

Who will benefit:

Patients with recurrent or advanced endometrial cancer will benefit from the assay, which will help physicians determine whether they are eligible for treatment with JEMPERLI monotherapy, which provides a new therapeutic option for women with MMR-deficient endometrial cancer.

Endometrial Carcinoma accounts for 90% of all Uterine cancers in the U.S.2

Pathology expertise:

LMC Pathology Services, a Sonic Healthcare anatomic pathology practice, is a leading independent pathology services and cancer diagnostics laboratory. Roche Tissue Diagnostics has selected LMC Pathology Services as the first reference laboratory to perform its newly approved MMR RxDx Panel.

Our expert pathologists at Sonic Healthcare USA are prepared to work collaboratively with physicians to provide meaningful testing results which may translate to more effective patient treatment options.

LMC Pathology Services’ efforts are focused on the improvement and delivery of accurate diagnostic, prognostic and therapeutic information. Our goal is to serve every community with advanced medicine and premier healthcare services. With our extensive pathology expertise, LMC Pathology Services integrates the highest quality of diagnostic services, professional consultation and expert analysis resulting in quality patient care.

Surgical Pathology Report Sample

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

Sonic Healthcare USA, including its subsidiaries, does not dispense medical advice. The content in this marketing collateral is intended for informational purposes only and does not constitute legal, medical or any professional advice. Please consult your physician or a healthcare provider for additional information.

[1] Bray 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

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