--- title: BioGX announces FDA Emergency Use Authorization submission of extraction-free direct RT-PCR test for COVID-19 description: BioGX submits extraction-free, direct RT-PCR COVID-19 test for FDA Emergency Use Authorization image: https://news.lifesciencenewswire.com/hubfs/BioGX%20Logo%2010_01_2020.png --- [![Life Science Newswire 2](https://news.lifesciencenewswire.com/hs-fs/hubfs/Life%20Science%20Newswire%202.png?width=203&height=60&name=Life%20Science%20Newswire%202.png "Life Science Newswire 2")](https://lifesciencenewswire.com/) - [Newsroom](https://news.lifesciencenewswire.com/newsroom) - [Back to the main site](https://lifesciencenewswire.com/) ![LSNewswire-main-header-banner-v2-1](https://news.lifesciencenewswire.com/hubfs/LSNewswire-main-header-banner-v2-1.jpg "LSNewswire-main-header-banner-v2-1") # Newsroom #### Categories ![Arrow](https://cdn2.hubspot.net/hubfs/3842749/ps4-Pack/sidebar.svg "Arrow") #### Subscribe![](https://cdn2.hubspot.net/hubfs/3842749/ps4-Pack/subscribe-rss-button.svg) ![](https://cdn2.hubspot.net/hubfs/3842749/ps4-Pack/close-button.svg) ### Choose a Category - 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[Pharmacy (4)](https://news.lifesciencenewswire.com/newsroom/tag/pharmacy) - [Research (47)](https://news.lifesciencenewswire.com/newsroom/tag/research) - [Veterinary (5)](https://news.lifesciencenewswire.com/newsroom/tag/veterinary) - [Water (8)](https://news.lifesciencenewswire.com/newsroom/tag/water) See all ### Subscribe to Email Updates - ##### SHARE - - - # [BioGX announces FDA Emergency Use Authorization submission of extraction-free direct RT-PCR test for COVID-19](https://news.lifesciencenewswire.com/newsroom/biogx-announces-fda-emergency-use-authorization-submission-of-extraction-free-direct-rt-pcr-test-for-covid-19) October 13, 2020 *World’s Simplest High Throughput RT-PCR Test for COVID-19 has the potential to increase testing capacity by millions per week* ![BioGX Logo 10_01_2020](https://news.lifesciencenewswire.com/hs-fs/hubfs/BioGX%20Logo%2010_01_2020.png?width=300&name=BioGX%20Logo%2010_01_2020.png)BioGX, a molecular diagnostics solutions company, announced FDA Emergency Use Authorization (EUA) submission of an extraction-free, direct sample addition RT-PCR test for detection of SARS-CoV-2 viral RNA in patients suspected of COVID-19. The *Xfree®* COVID-19 Direct RT-PCR test (“*Xfree* COVID-19”) is a complete test in a single vial, lyophilized in the trusted BioGX Sample-Ready™ format. The user would simply Just Add Water™, the patient sample, and run the test on a validated real-time PCR instrument. “*Xfree* is a breakthrough in COVID-19 RT-PCR testing. Direct addition of patient samples without any pre-processing or extraction not only overcomes critical reagents supply issues, but also significantly shortens the results turnaround time. The fast and simple workflow is designed to help laboratories increase their testing capacity without adding expert personnel or new automation”, said Shazi Iqbal, Ph.D., CEO of BioGX.   “We believe *Xfree* is a game-changer. *Xfree* converts the most ubiquitous real-time PCR instruments into high throughput Sample-to-Answer machines - potentially augmenting the COVID-19 PCR testing capacity by millions”, said Michael Vickery, Ph.D., EVP & CSO of BioGX. *Xfree*® COVID-19 clinical performance study by direct, extraction-free testing of 77 patient samples demonstrated 98% Positive Percent Agreement (PPA) and 100% Negative Percent Agreement (NPA) when compared to the highly sensitive extraction-based BD-BioGX SARS-CoV-2 BD MAX™ test (FDA-EUA). Comparison with extracted viral RNA using QIAamp® DSP Viral RNA extraction kit (CDC EUA method) demonstrated 100% PPA and 100% NPA for *Xfree*® COVID-19. A single 96-well plate instrument can generate up to 1,500 test results every 24 hours, while a 384-well plate instrument can generate up to 6,000 test results. “Our current production capacity for the *Xfree* COVID-19 is nearly 2 million tests per week and can readily scale to 4 million per week. With efficient and early planning, we were able to secure long-term supply of critical raw materials to avoid any potential supply disruptions”, said Shahin Iqbal, Ph.D., SVP of Global Operations. The *Xfree®* COVID-19 test is validated for use on QuantStudio™ 5 and CFX Touch™ real-time PCR instruments with the most common specimen types - nasopharyngeal and oropharyngeal (throat) swabs with collections in UTM, UVT, VTM and saline. In addition to extraction-free direct testing, *Xfree®* COVID-19 is validated to test samples extracted with magnetic beads or silica column extraction methods. *Xfree®* can be shipped anywhere in the world with no refrigeration required. Customers can request information on *Xfree®* COVID-19 by contacting BioGX at [covid19@biogx.com](mailto:covid19@biogx.com). For more information on BioGX, please visit [BioGX.com](https://biogx.com/).   Sample-Ready, Just Add Water and Xfree are registered or pending trademarks of BioGX, Inc. BD MAX trademarks are property of Becton, Dickinson and Company (NYSE: BDX) QuantStudio 5 is a trademark of Thermo Fisher Scientific (NYSE: TMO) QIAamp is registered or pending trademark of QIAGEN Group (NYSE: QGEN) Bio-Rad and Bio-Rad CFX96 Touch is a trademark of Bio-Rad Laboratories, Inc. (NYSE: BIO)   Categories: [Biomanufacturing](https://news.lifesciencenewswire.com/newsroom/tag/biomanufacturing), [Healthcare](https://news.lifesciencenewswire.com/newsroom/tag/healthcare), [COVID-19](https://news.lifesciencenewswire.com/newsroom/tag/covid-19) ##### Browse more news ## Recent releases #### [Enhanced Compliance Inc. (ECI) Appoints Taranjit S. 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