Pillar Biosciences Receives China National Medical Products Administration (NMPA) Approval for oncoRevealTM Dx Colon Cancer Test
– Highly accurate, tissue-based next-generation sequencing (NGS) assay approved in China as a companion diagnostic for targeted therapies for colon cancer
NATICK, Mass., Aug. 22, 2022–(BUSINESS WIRE)–Pillar Biosciences, the leader of Decision Medicine™, developers and distributors of next-generation sequencing (NGS) assays that localize testing and reduce time to treatment initiation and overall testing costs , today announced that its oncoRevealMT The Dx Colon Cancer Assay has received approval from the China National Medical Products Administration (NMPA). The IVD test is now commercially available in China, the United States and Europe as a companion diagnostic (CDx) to identify colorectal cancer patients whose tumors express wild-type KRAS status and may benefit treatment with specific targeted therapies.
“The oncoReveal™ Dx Colon Cancer Test localizes NGS testing and efficiently provides a highly accurate genetic profile of KRAS mutations in patients with metastatic colorectal cancer,” said Randy Pritchard, CEO of Pillar Biosciences. “This approval is important for oncologists across China who need a more streamlined, efficient and accurate way to identify the right treatment for their individual patients. By making testing more widely available and enabling faster results, we can significantly reduce the time it takes to initiate treatment and enable patients to continue with more confidence throughout their life course.”
The oncoReveal™ Dx Colon Cancer Test 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 test uses Pillar’s highly accurate and sensitive SLIMamp® NGS test technology to generate data that optimizes the selection of precision therapies for cancer patients. It 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 Premarketing Approval (PMA) from the U.S. Food and Drug Administration (FDA) in July 2021.
About Pilar Biosciences
Pillar Biosciences is the leader in Decision Medicine™, which uses highly accurate and sensitive next-generation sequencing (NGS) assay technology to generate data that optimizes the selection of precision therapies for cancer patients, from profiling of the tumor to therapy selection and recurrence monitoring. Pillar’s NGS testing solutions, including the FDA-cleared oncoReveal™ Dx lung and colon cancer test, are powered by the company’s proprietary SLIMamp® and PiVAT® technologies, and decentralize the testing process, reducing diagnostic costs and improving access and efficiency of complex NGS tests for pathologists, prescribers and patients worldwide. The company has more than 20 NGS test products available in IVD or RUO formats, and several more in various stages of development, including an oncoReveal™ CDx pan-cancer test and two liquid biopsy offerings. Pillar’s patented technologies have been shown to deliver accurate, actionable data in as little as 48 hours, allowing physicians to select appropriate therapies and monitor patient response. Pillar Biosciences has operations in Natick, MA and Shanghai, China. For more information, visit www.pillar-biosciences.com.
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Joshua R. Mansbach