{"id":50737,"date":"2022-11-10T21:02:16","date_gmt":"2022-11-10T20:02:16","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/biogx-expands-fda-eua-with-pixl-portable-qpcr-system-for-its-direct-sample-covid-19-assay\/"},"modified":"2022-11-10T21:02:16","modified_gmt":"2022-11-10T20:02:16","slug":"biogx-expands-fda-eua-with-pixl-portable-qpcr-system-for-its-direct-sample-covid-19-assay","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/biogx-expands-fda-eua-with-pixl-portable-qpcr-system-for-its-direct-sample-covid-19-assay\/","title":{"rendered":"BioGX Expands FDA EUA with pixl\u2122 Portable qPCR System for its Direct-Sample COVID-19 Assay"},"content":{"rendered":"<div>\n<p>BIRMINGHAM, Ala.&#8211;(BUSINESS WIRE)&#8211;BioGX, a global provider of easy molecular diagnostic solutions since 2007, announced that the US FDA has updated their original (June 29, 2021) Direct Sample <i>Xfree<\/i><sup>\u2122<\/sup> COVID-19 Emergency Use Authorization to increase the shelf-life of the assay reagent to 15 months and expand its use to additional real-time PCR platforms, including BioGX\u2019s pixl<sup>\u2122<\/sup> real-time PCR platform.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20221110006045\/en\/1633533\/5\/BioGX_-_New_Logo_-_final.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221110006045\/en\/1633533\/21\/BioGX_-_New_Logo_-_final.jpg\"><\/a><\/p>\n<p>\nThe innovative BioGX <i>Xfree<\/i><sup>\u2122<\/sup> Direct RT-PCR product is offered as a complete lyophilized test in a single vial. Upon rehydration with water, the test enables extraction-free, direct patient sample addition to a PCR tube which can be run on the BioGX pixl<sup>\u2122<\/sup> platform, Bio Molecular Systems MIC instrument and a variety of ubiquitous, high-throughput real-time PCR platforms. The Xfree assay can accept a wide variety of patient sample collections and is compatible with most commonly used transport\/collection media types.\n<\/p>\n<p>\n\u201cWith the pixl platform, customers can now generate fast sample-to-answer results on a portable, compact device. We expect the expanded EUA to provide broader access to clinical laboratories for decentralized PCR-based testing, enabling faster, better, low cost near-patient molecular diagnosis,\u201d said Shazi Iqbal, Ph.D., CEO of BioGX.\n<\/p>\n<p>\nAdditional information can be requested by contacting BioGX at Ph: +1.205.250.8055 or <a target=\"_blank\" href=\"&#x6d;&#x61;&#105;l&#x74;&#x6f;&#58;in&#x66;&#x6f;&#64;b&#x69;&#x6f;&#103;&#120;&#46;&#x63;&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#105;&#x6e;&#102;&#x6f;&#64;&#x62;i&#111;&#x67;&#120;&#x2e;c&#x6f;m<\/a>.\n<\/p>\n<p>\n<b>About BioGX<\/b>\n<\/p>\n<p>\nBioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics. BioGX, Inc., headquartered in Birmingham, Alabama and Dallas, TX, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively \u201cBioGX\u201d), operates in a cGMP compliant environment certified to ISO 13485 medical device development and manufacturing standards. The proprietary Sample-Ready<sup>\u2122<\/sup> technology is at the core of all product offerings for Clinical, Food Safety, Pharma QC and Water Quality molecular testing. BioGX\u2019s 60+ multiplex real-time PCR products are marketed and sold in several countries through its Global Distribution Network.\n<\/p>\n<p>\nFor more information on BioGX, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fbiogx.com%2F&amp;esheet=52966851&amp;newsitemid=20221110006045&amp;lan=en-US&amp;anchor=BioGX.com&amp;index=1&amp;md5=73a4fba009c71d5e133944dfba230d4b\" rel=\"nofollow noopener\" shape=\"rect\">BioGX.com<\/a>.\n<\/p>\n<p>\nSample-Ready, Just Add Water and Xfree are trademarks of BioGX, Inc.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nBioGX contact:<br \/>\n<br \/>Mohammed Merchant<br \/>\n<br \/>Office: +1.205.250.8055<br \/>\n<br \/>Email: <a target=\"_blank\" href=\"mailto&#58;&#109;&#97;&#114;&#107;&#101;&#116;&#x69;&#x6e;&#x67;&#x40;&#x62;&#x69;&#x6f;&#x67;&#x78;&#x2e;&#x63;&#x6f;m\" rel=\"nofollow noopener\" shape=\"rect\">&#x6d;&#x61;&#x72;&#x6b;&#x65;&#x74;&#x69;&#x6e;&#x67;&#x40;&#x62;&#x69;&#x6f;&#x67;&#x78;&#x2e;&#x63;&#x6f;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>BIRMINGHAM, Ala.&#8211;(BUSINESS WIRE)&#8211;BioGX, a global provider of easy molecular diagnostic solutions since 2007, announced that the US FDA has updated their original (June 29, 2021) Direct Sample Xfree\u2122 COVID-19 Emergency Use Authorization to increase the shelf-life of the assay reagent to 15 months and expand its use to additional real-time PCR platforms, including BioGX\u2019s pixl\u2122 &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/biogx-expands-fda-eua-with-pixl-portable-qpcr-system-for-its-direct-sample-covid-19-assay\/\">[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-50737","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>BioGX Expands FDA EUA with pixl\u2122 Portable qPCR System for its Direct-Sample COVID-19 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\/biogx-expands-fda-eua-with-pixl-portable-qpcr-system-for-its-direct-sample-covid-19-assay\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BioGX Expands FDA EUA with pixl\u2122 Portable qPCR System for its Direct-Sample COVID-19 Assay - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"BIRMINGHAM, Ala.&#8211;(BUSINESS WIRE)&#8211;BioGX, a global provider of easy molecular diagnostic solutions since 2007, announced that the US FDA has updated their original (June 29, 2021) Direct Sample Xfree\u2122 COVID-19 Emergency Use Authorization to increase the shelf-life of the assay reagent to 15 months and expand its use to additional real-time PCR platforms, including BioGX\u2019s pixl\u2122 ... 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