{"id":54999,"date":"2023-03-20T17:05:05","date_gmt":"2023-03-20T16:05:05","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/new-stilla-ruby-chip-and-naica-system-21-cfr-part-11-compliance-enable-full-automation-of-digital-pcr-testing-for-clinically-oriented-applications\/"},"modified":"2023-03-20T17:05:05","modified_gmt":"2023-03-20T16:05:05","slug":"new-stilla-ruby-chip-and-naica-system-21-cfr-part-11-compliance-enable-full-automation-of-digital-pcr-testing-for-clinically-oriented-applications","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/new-stilla-ruby-chip-and-naica-system-21-cfr-part-11-compliance-enable-full-automation-of-digital-pcr-testing-for-clinically-oriented-applications\/","title":{"rendered":"New Stilla Ruby Chip and naica\u00ae system 21 CFR Part 11 compliance enable full automation of digital PCR testing for clinically-oriented applications"},"content":{"rendered":"<div>\n<p>BOSTON&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/PCR?src=hash\" target=\"_blank\" rel=\"noopener\">#PCR<\/a>&#8211;Stilla Technologies, <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.stillatechnologies.com%2F&amp;esheet=53364687&amp;newsitemid=20230320005515&amp;lan=en-US&amp;anchor=the+multiplex+digital+PCR+company&amp;index=1&amp;md5=2c8ac9aeb1265bad780a5b63727078dd\" rel=\"nofollow noopener\" shape=\"rect\">the multiplex digital PCR company<\/a>, has recently introduced the <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.stillatechnologies.com%2Fmultiplex-pcr%2Fdigital-pcr-reagents%2F&amp;esheet=53364687&amp;newsitemid=20230320005515&amp;lan=en-US&amp;anchor=Ruby+Chip&amp;index=2&amp;md5=f3da0a5375891bd1522f7201bca261c5\" rel=\"nofollow noopener\" shape=\"rect\">Ruby Chip<\/a>, the industry\u2019s first \u2018load-and-go\u2019 consumable for digital PCR, optimized for its naica\u00ae system. <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.stillatechnologies.com%2Fmultiplex-pcr%2Fdigital-pcr%2F&amp;esheet=53364687&amp;newsitemid=20230320005515&amp;lan=en-US&amp;anchor=The+naica%26%23174%3B+system&amp;index=3&amp;md5=39c3fbface480928146df84c60ffa6d7\" rel=\"nofollow noopener\" shape=\"rect\">The naica\u00ae system<\/a>, which now supports 21 CFR Part 11 regulatory compliance, is part of a fully-automated sample-to-results workflow \u2013 the first of its kind for digital PCR. This platform serves the growing throughput and regulatory requirements of many clinically-oriented applications, such as in <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.stillatechnologies.com%2Fpcr-applications%2Faav-vector-gene-therapy%2F&amp;esheet=53364687&amp;newsitemid=20230320005515&amp;lan=en-US&amp;anchor=cell+and+gene+therapy&amp;index=4&amp;md5=d6fd0600af16fa92552d4a260b1c49e6\" rel=\"nofollow noopener\" shape=\"rect\">cell and gene therapy<\/a> development and quality control or for <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.stillatechnologies.com%2Fpcr-applications%2Fliquid-biopsy-test%2F&amp;esheet=53364687&amp;newsitemid=20230320005515&amp;lan=en-US&amp;anchor=liquid+biopsy+applications&amp;index=5&amp;md5=3ae0dd0c95e8f7aaf8e0779ffb02998c\" rel=\"nofollow noopener\" shape=\"rect\">liquid biopsy applications<\/a> for the detection of circulating tumor DNA (ctDNA).\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230320005515\/en\/1412589\/5\/Stilla_Technologies_Logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230320005515\/en\/1412589\/21\/Stilla_Technologies_Logo.jpg\"><\/a><\/p>\n<p>\nWith adjustable throughput of up to 96 samples processing capability in under three hours, the Ruby Chip is designed with standard SBS plate spacing compatible with multichannel pipettes for manual loading and can be easily integrated with common liquid handling robots. A key feature of the Ruby Chip is that it comes ready-to-use and preloaded with sealed chambers, enabling the addition of sample mix in a single, foil-piercing pipetting step. This eliminates cross contamination and reduces handling.\n<\/p>\n<p>\n\u201cAt Stilla, we seek to empower researchers with an efficient and streamlined way to load their precious biological samples for analysis, with precision and accuracy, and with minimal hands-on time,\u201d says Remi Dangla, founder and CTO of Stilla Technologies. Notes Dangla, \u201cAs an example of our capability, we are partnering with Promega Corporation to create a fully automated solution for digital PCR analysis. This workflow will combine the naica\u00ae system with Promega\u2019s automated sample preparation capabilities along with their Maxwell\u00ae systems for sample extraction.\u201d\n<\/p>\n<p>\n\u201cWith these new features, Stilla is responding directly to market demand for regulatory-compliant software, as well as for reduced manual handling,\u201d says Philippe Mourere, President and CEO of Stilla Technologies. \u201cThe naica\u00ae system meets these standards, and in the context of cell and gene therapy and liquid biopsy\/ctDNA quantification, end users find utility for the platform across multiple processes, be it in analytical development, sample screening\/patient monitoring, or for quality assessment in the scaled-up manufacturing of a therapeutic.\u201d\n<\/p>\n<p>\nStilla Technologies and Promega Corporation will be exhibiting at the upcoming AACR Annual Meeting 2023, being hosted in Orlando, FL. At the conference, the companies plan to present the scientific poster titled, \u201cAutomated workflow for sensitive and robust nucleic acid quantification: sample extraction and dPCR analysis utilizing the MaxPrep\u2122 Liquid Handler, Maxwell\u00ae extraction system, and highplex assays on the naica\u00ae system\u201d during a session on Monday, April 17.\n<\/p>\n<p>\n<b>About Stilla Technologies<\/b>\n<\/p>\n<p>\nStilla Technologies is the multiplex digital PCR company transforming complex genomic data into actionable insights across a wide range of research and clinical applications including cancer and liquid biopsy studies, cell and gene therapies, infectious disease detection, and food and environmental testing. Stilla\u2019s groundbreaking Crystal Digital PCR\u2122 solution, the naica\u00ae system, is the industry\u2019s first digital PCR system featuring six fluorescent channels, providing biomedical researchers and clinicians the highest multiplexing and detection capacity available on the market. Stilla has U.S. headquarters in Boston, MA, European headquarters in Paris, France, and strategic distribution and business partnerships in China and throughout EMEA. To learn more, visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.stillatechnologies.com%2F&amp;esheet=53364687&amp;newsitemid=20230320005515&amp;lan=en-US&amp;anchor=www.stillatechnologies.com&amp;index=6&amp;md5=03829901d651e851956a3974cd9b9836\" rel=\"nofollow noopener\" shape=\"rect\">www.stillatechnologies.com<\/a>.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nMedia:<br \/>\n<br \/>Christopher Hynes<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#x69;l&#116;&#x6f;:&#99;&#x68;r&#105;&#x73;t&#111;&#x70;&#x68;&#101;&#x72;&#x2e;h&#121;&#x6e;e&#115;&#x40;s&#116;&#x69;&#x6c;&#108;&#x61;&#x74;e&#99;&#x68;n&#111;&#x6c;o&#103;&#x69;e&#115;&#x2e;&#x63;&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x63;&#104;&#114;i&#x73;&#x74;&#111;p&#x68;&#x65;&#114;&#46;h&#x79;&#110;&#101;s&#x40;&#x73;&#116;i&#x6c;&#x6c;&#97;&#116;e&#x63;&#x68;&#110;o&#x6c;&#x6f;&#103;i&#x65;&#x73;&#46;&#99;o&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>BOSTON&#8211;(BUSINESS WIRE)&#8211;#PCR&#8211;Stilla Technologies, the multiplex digital PCR company, has recently introduced the Ruby Chip, the industry\u2019s first \u2018load-and-go\u2019 consumable for digital PCR, optimized for its naica\u00ae system. The naica\u00ae system, which now supports 21 CFR Part 11 regulatory compliance, is part of a fully-automated sample-to-results workflow \u2013 the first of its kind for digital PCR. &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/new-stilla-ruby-chip-and-naica-system-21-cfr-part-11-compliance-enable-full-automation-of-digital-pcr-testing-for-clinically-oriented-applications\/\">[Read more&#8230;]<\/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-54999","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New Stilla Ruby Chip and naica\u00ae system 21 CFR Part 11 compliance enable full automation of digital PCR testing for clinically-oriented applications - 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\/new-stilla-ruby-chip-and-naica-system-21-cfr-part-11-compliance-enable-full-automation-of-digital-pcr-testing-for-clinically-oriented-applications\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New Stilla Ruby Chip and naica\u00ae system 21 CFR Part 11 compliance enable full automation of digital PCR testing for clinically-oriented applications - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"BOSTON&#8211;(BUSINESS WIRE)&#8211;#PCR&#8211;Stilla Technologies, the multiplex digital PCR company, has recently introduced the Ruby Chip, the industry\u2019s first \u2018load-and-go\u2019 consumable for digital PCR, optimized for its naica\u00ae system. 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The naica\u00ae system, which now supports 21 CFR Part 11 regulatory compliance, is part of a fully-automated sample-to-results workflow \u2013 the first of its kind for digital PCR. ... 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