{"id":46311,"date":"2022-07-19T13:01:59","date_gmt":"2022-07-19T11:01:59","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/pillar-biosciences-announces-u-s-food-and-drug-administration-acceptance-of-premarket-approval-pma-supplement-application-for-pan-cancer-oncoreveal-cdx\/"},"modified":"2022-07-19T13:01:59","modified_gmt":"2022-07-19T11:01:59","slug":"pillar-biosciences-announces-u-s-food-and-drug-administration-acceptance-of-premarket-approval-pma-supplement-application-for-pan-cancer-oncoreveal-cdx","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/pillar-biosciences-announces-u-s-food-and-drug-administration-acceptance-of-premarket-approval-pma-supplement-application-for-pan-cancer-oncoreveal-cdx\/","title":{"rendered":"Pillar Biosciences Announces U.S. Food and Drug Administration Acceptance of Premarket Approval (PMA) Supplement Application for Pan-cancer oncoReveal\u2122 CDx"},"content":{"rendered":"
\n

\n\u02d7 PMA supplement will further expand oncoReveal\u2122 Dx indication\/label to include ability to detect additional eight cancer types<\/i>\n<\/p>\n

\n\u02d7 Company continues to execute on its strategy to bring highly accurate and sensitive NGS cancer diagnostics to enable localized testing<\/i>\n<\/p>\n

NATICK, Mass.–(BUSINESS WIRE)–Pillar Biosciences<\/a>, the leader in Decision Medicine\u2122, which develops and distributes next-generation sequencing (NGS) tests to localize testing and reduce time to treatment initiation and overall testing costs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company\u2019s Premarket Approval (PMA) supplement application for its Pan-cancer oncoReveal\u2122 CDx. The supplement, if approved, will expand the label\/indication of Pillar Bioscience\u2019s oncoReveal\u2122 Dx Lung & Colon Cancer Assay to include actionable targets for eight additional cancer types, bringing the total detectable cancers to ten.\n<\/p>\n

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

\n\u201cWe are pleased to take the next step towards expanding the clinical utility of the oncoReveal\u2122 Dx, which is the first FDA-approved multi-cancer IVD launched in the market,\u201d said Randy Pritchard, CEO of Pillar Biosciences. \u201cWith our innovative technology platform, we built an assay with extraordinary sensitivity, simple workflow, and fast turnaround time to enable localized testing that can be performed in any NGS lab, whether hospital-based or a commercial reference laboratory. This localized approach demonstrates our commitment to bringing highly accurate and actionable NGS testing to clinical laboratories and biopharmaceutical companies in order to help improve treatment decisions and outcomes that are accessible to everyone, everywhere.\n<\/p>\n

\nThe Pan-cancer oncoReveal\u2122 CDx is developed for tumor profiling and therapy selection, and includes actionable targets on ten of the most common cancer types. The panel provides comprehensive genomic results, covering 22 clinically relevant genes in one multiplex reaction, and has a fully automatable workflow that can be performed by any clinical laboratory with a sample-to-report time of as little as 48 hours.\n<\/p>\n

\nThe PMA supplement application follows the original PMA approval of oncoReveal\u2122 Dx Lung & Colon Cancer Assay in July 2021.\n<\/p>\n

\nAbout Pillar Biosciences<\/b>\n<\/p>\n

\nPillar 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, are 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 clinicians, prescribers, and patients globally. 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>\n<\/p>\n

\nMedia 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":"

\u02d7 PMA supplement will further expand oncoReveal\u2122 Dx indication\/label to include ability to detect additional eight cancer types \u02d7 Company continues to execute on its strategy to bring highly accurate and sensitive NGS cancer diagnostics to enable localized testing NATICK, Mass.–(BUSINESS WIRE)–Pillar Biosciences, the leader in Decision Medicine\u2122, which develops and distributes next-generation sequencing (NGS) … [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-46311","6":"format-standard","7":"category-industry"},"yoast_head":"\nPillar Biosciences Announces U.S. Food and Drug Administration Acceptance of Premarket Approval (PMA) Supplement Application for Pan-cancer oncoReveal\u2122 CDx - 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-announces-u-s-food-and-drug-administration-acceptance-of-premarket-approval-pma-supplement-application-for-pan-cancer-oncoreveal-cdx\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pillar Biosciences Announces U.S. Food and Drug Administration Acceptance of Premarket Approval (PMA) Supplement Application for Pan-cancer oncoReveal\u2122 CDx - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"\u02d7 PMA supplement will further expand oncoReveal\u2122 Dx indication\/label to include ability to detect additional eight cancer types \u02d7 Company continues to execute on its strategy to bring highly accurate and sensitive NGS cancer diagnostics to enable localized testing NATICK, Mass.–(BUSINESS WIRE)–Pillar Biosciences, the leader in Decision Medicine\u2122, which develops and distributes next-generation sequencing (NGS) ... 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