Categories: Wire Stories

Pillar Biosciences Receives China National Medical Products Administration (NMPA) Approval for oncoRevealTM Dx Colon Cancer Assay

– Highly-accurate, tissue-based, next-generation sequencing (NGS) test approved in China as a companion diagnostic for targeted colon cancer therapies

NATICK, Mass.–(BUSINESS WIRE)–Pillar Biosciences, the leader in Decision Medicine�, developers and distributors of next-generation sequencing (NGS) tests which localize testing and reduce time to treatment initiation and overall testing costs, today announced that its oncoRevealTM Dx Colon Cancer Assay has received approval from the China National Medical Products Administration (NMPA). The IVD assay is now commercially available in China, the U.S., and Europe as a companion diagnostic (CDx) to identify patients with colorectal cancer whose tumors express wild-type KRAS status and may benefit from treatment with specific targeted therapies.

“The oncoReveal™ Dx Colon Cancer Assay localizes NGS testing and efficiently provides a highly accurate genetic profile of KRAS mutations in metastatic colorectal cancer patients,” said Randy Pritchard, Chief Executive Officer of Pillar Biosciences. “This approval is important for oncologists across China who need a more streamlined, efficient and accurate means of identifying the right therapy for their individual patients. By making testing more widely available, and enabling faster results, we can significantly reduce the amount of time it takes to initiate treatment and enable patients to more confidently continue along their life journey.”

The oncoReveal™ Dx Colon Cancer Assay is a companion diagnostic test that identifies patients with metastatic colorectal cancer who have KRAS wild-type tumor status and may benefit from treatment with approved therapies, Erbitux® (cetuximab) or Vectibix® (panitumumab). The assay utilizes Pillar’s highly accurate and sensitive SLIMamp® NGS testing technology to generate data that optimizes selection of precision therapies for cancer patients. This is the Company’s first NMPA approved diagnostic product. Pillar’s oncoReveal™ Dx Lung & Colon Cancer Assay previously received CE-IVD certification in Europe in April 2020 and U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) in July 2021.

About Pillar Biosciences

Pillar Biosciences is the leader in Decision Medicine™, which is the utilization of highly accurate and sensitive next-generation sequencing (NGS) testing technology to generate data that optimizes selection of precision therapies for cancer patients, from tumor profiling to therapy selection, and recurrence monitoring. Pillar’s NGS testing solutions, including the FDA-approved oncoReveal™ Dx Lung and Colon Cancer Assay, is powered by the Company’s proprietary SLIMamp® and PiVAT® technologies, and decentralizes the testing process, reducing diagnostic costs and improving access and efficiency of complex NGS testing for pathologists, prescribers, and patients worldwide. The Company has more than 20 NGS testing products available in IVD or RUO formats, and several others in various stages of development, including a pan-cancer oncoReveal™ CDx assay, and two liquid biopsy offerings. Pillar’s patented technologies have been shown to provide accurate and actionable data in as little as 48 hours, which allows physicians to select appropriate therapies and monitor the patient’s response. Pillar Biosciences has operations in Natick, MA and Shanghai, China. For more information, visit www.pillar-biosciences.com.

Contacts

Investor Contact:
Dawn Schottlandt

Argot Partners

212-600-1902

Pillar@argotpartners.com

Media Contact:
Joshua R. Mansbach

Argot Partners

212-600-1902

Pillar@argotpartners.com

Alex

Recent Posts

China Focus: Technology sows seeds of hope in combating desertification

HOHHOT, CHINA - Media OutReach Newswire - 23 December 2024 - China's National Forestry and…

10 hours ago

Novautek Honored with the “Outstanding SME ESG and Business Performance Award”

HONG KONG SAR - EQS Newswire - 23 December 2024 - Novautek Autonomous Driving Limited…

12 hours ago

V-GREEN and Xanh SM Indonesia sign MoU with Lippo for comprehensive green ecosystem in Indonesia

JAKARTA, INDONESIA - Media OutReach Newswire - 23 December 2024 - V-GREEN and PT Xanh…

12 hours ago

Molex Anticipates Steady Growth in High-Speed Connectivity in 2025, Driving Electronics Design Innovations Across Diverse Industry Sectors

Increase in opportunities predicted for high-speed optical transceivers and miniaturized connectivity solutions to address data-intensive…

14 hours ago

Celebrating 25 Years of Excellence: DYXnet Embarks the New Chapter of Digital Transformation

HONG KONG SAR - Media OutReach Newswire - 23 December 2024 - DYXnet, a wholly-owned…

15 hours ago

The Top 10 Best Places to Work in Egypt for 2024 revealed

CAIRO, EGYPT - Media OutReach Newswire - 23 December 2024 - Eand, Novo Nordisk, BSH,…

17 hours ago