{"id":47515,"date":"2022-08-22T13:02:07","date_gmt":"2022-08-22T11:02:07","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/pillar-biosciences-receives-china-national-medical-products-administration-nmpa-approval-for-oncorevealtm-dx-colon-cancer-assay\/"},"modified":"2022-08-22T13:02:07","modified_gmt":"2022-08-22T11:02:07","slug":"pillar-biosciences-receives-china-national-medical-products-administration-nmpa-approval-for-oncorevealtm-dx-colon-cancer-assay","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/pillar-biosciences-receives-china-national-medical-products-administration-nmpa-approval-for-oncorevealtm-dx-colon-cancer-assay\/","title":{"rendered":"Pillar Biosciences Receives China National Medical Products Administration (NMPA) Approval for oncoRevealTM Dx Colon Cancer Assay"},"content":{"rendered":"
\n

\n– Highly-accurate, tissue-based, next-generation sequencing (NGS) test approved in China as a companion diagnostic for targeted colon cancer therapies<\/i>\n<\/p>\n

NATICK, Mass.–(BUSINESS WIRE)–Pillar Biosciences<\/a>, the leader in Decision Medicine\u2122, 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<\/sup> 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.\n<\/p>\n

<\/a><\/p>\n

\n\u201cThe oncoReveal\u2122 Dx Colon Cancer Assay localizes NGS testing and efficiently provides a highly accurate genetic profile of KRAS mutations in metastatic colorectal cancer patients,\u201d said Randy Pritchard, Chief Executive Officer of Pillar Biosciences. \u201cThis 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.\u201d\n<\/p>\n

\nThe oncoReveal\u2122 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\u00ae (cetuximab) or Vectibix\u00ae (panitumumab). <\/i><\/b>The assay utilizes Pillar\u2019s highly accurate and sensitive SLIMamp\u00ae NGS testing technology to generate data that optimizes selection of precision therapies for cancer patients. This is the Company\u2019s first NMPA approved diagnostic product. Pillar\u2019s oncoReveal\u2122 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.\n<\/p>\n

\nAbout Pillar Biosciences
\n
<\/b>Pillar Biosciences is the leader in Decision Medicine\u2122, 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\u2019s NGS testing solutions, including the FDA-approved oncoReveal\u2122 Dx Lung and Colon Cancer Assay, is powered by the Company\u2019s proprietary SLIMamp\u00ae and PiVAT\u00ae 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\u2122 CDx assay, and two liquid biopsy offerings. Pillar\u2019s 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\u2019s response. Pillar Biosciences has operations in Natick, MA and Shanghai, China. For more information, visit www.pillar-biosciences.com<\/a>.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nInvestor Contact:<\/span><\/b>
Dawn Schottlandt
\n
Argot Partners
\n
212-600-1902
\n
Pillar@argotpartners.com<\/a><\/p>\n

Media Contact:<\/span><\/b>
Joshua R. Mansbach
\n
Argot Partners
\n
212-600-1902
\n
Pillar@argotpartners.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

– 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\u2122, 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 … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-47515","6":"format-standard","7":"category-industry"},"yoast_head":"\nPillar Biosciences Receives China National Medical Products Administration (NMPA) Approval for oncoRevealTM Dx Colon Cancer Assay - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/pillar-biosciences-receives-china-national-medical-products-administration-nmpa-approval-for-oncorevealtm-dx-colon-cancer-assay\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pillar Biosciences Receives China National Medical Products Administration (NMPA) Approval for oncoRevealTM Dx Colon Cancer Assay - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"– 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\u2122, 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 ... 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