.jpg)
1 hour ago
2
Article content
Promega MSI technology will aid in the identification of patients with microsatellite stable (MSS) endometrial carcinoma
THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLY
Subscribe now to read the latest news in your city and across Canada.
- Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman, and others.
- Daily content from Financial Times, the world's leading global business publication.
- Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.
- National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.
- Daily puzzles, including the New York Times Crossword.
SUBSCRIBE TO UNLOCK MORE ARTICLES
Subscribe now to read the latest news in your city and across Canada.
- Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman and others.
- Daily content from Financial Times, the world's leading global business publication.
- Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.
- National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.
- Daily puzzles, including the New York Times Crossword.
REGISTER / SIGN IN TO UNLOCK MORE ARTICLES
Create an account or sign in to continue with your reading experience.
- Access articles from across Canada with one account.
- Share your thoughts and join the conversation in the comments.
- Enjoy additional articles per month.
- Get email updates from your favourite authors.
THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK.
Create an account or sign in to continue with your reading experience.
- Access articles from across Canada with one account
- Share your thoughts and join the conversation in the comments
- Enjoy additional articles per month
- Get email updates from your favourite authors
Sign In or Create an Account
or
Article content
MADISON, Wis. — The U.S. Food and Drug Administration (FDA) has approved the Promega OncoMate® MSI Dx Analysis System as a companion diagnostic designed 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), Merck’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. This is the first Promega companion diagnostic to receive FDA approval.
Article content
Article content
Article content
OncoMate® MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue. MSI status can be used to guide treatment decisions and support precision oncology strategies in endometrial carcinoma.
Article content
By signing up you consent to receive the above newsletter from Postmedia Network Inc.
Article content
“This approval underscores the critical role diagnostics play in accurately matching the right patients, at the right time with the right therapy,” says Alok Sharma, Global Clinical Market Director at Promega. “We are committed to delivering reliable tools that guide clinical decisions and help improve patient outcomes.”
Article content
The approval was supported through a collaboration with Merck, which markets KEYTRUDA plus LENVIMA in collaboration with Eisai Co., Ltd. Together, the companies are working to advance personalized medicine and expand access to diagnostics that enable informed therapeutic choices.
Article content
OncoMate® MSI Dx Analysis System was previously cleared by the FDA as the first PCR-based molecular diagnostic for identifying colorectal cancer patients who may benefit from additional testing to diagnose Lynch syndrome. This approval applies to the United States and its territories. Promega MSI technology has received additional regulatory approvals in China and the European Union.
Article content
Learn more about Promega MSI technology here.
Article content
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Article content
About Promega Corporation
Article content
Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s portfolio of over 4,000 products supports a range of life science work across areas such as cell biology; DNA, RNA and protein analysis; drug development; human identification and molecular diagnostics. These tools and technologies have grown in their application over the last 45 years and are used today by scientists and technicians in labs for academic and government research, forensics, pharmaceuticals, clinical diagnostics and veterinary, agricultural and environmental testing. Promega is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors. Learn more at promega.com
Article content
Article content
Article content
View source version on businesswire.com:
Article content
Article content
Article content
Contacts
Article content
Penny Patterson
VP, Corporate Affairs
Promega Corporation
Phone: (608) 274-4330
E-mail: [email protected]
Article content
English (US)