The VENTANA MMR RxDX Panel is the first FDA-approved immunohistochemical (IHC) companion diagnostic (CDx) to identify endometrial cancer patients eligible for immunotherapy
The VENTANA MMR RxDX Panel is the first FDA-approved immunohistochemical (IHC) companion diagnostic (CDx) to identify endometrial cancer patients eligible for immunotherapy. (Credit: Shameer Pk from Pixabay)
LMC Pathology Services (LMC), a Sonic Healthcare USA Anatomic Pathology Practice, is the first reference laboratory in the United States to offer the VENTANA MMR RxDx Panel from Roche Diagnostics for evaluation of endometrial cancer, approved by the FDA on April 22, 2021. LMC is located in Las Vegas, Nevada, and specializes in anatomic pathology services for the Southwest region.
Aurora Research Institute (ARI), also a part of Sonic Healthcare USA’s Anatomic Pathology Division, served as a research test site to collect data to support Roche’s submission for U.S. Food and Drug Administration (FDA) approval of the test.
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 LMC pathologists following the FDA-approved protocol. Endometrial cancers determined to be dMMR (mismatch repair deficient) by Roche’s 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, as determined by an FDA approved test, that has progressed on or following prior treatment with a platinum-containing regimen. 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).
“This is a revolutionary breakthrough in managing the personalized treatment of women with endometrial cancer,” said Jonathan Hughes, MD, PhD, Managing Director of LMC Pathology Services. “Our practice is honored to be the first practice in the country performing and interpreting this assay, and our pathologists look forward to assisting our client physicians by providing the results as they plan therapeutic treatments for their patients,” added Dr. Hughes.
Source: Company Press Release