BioGX Announces FDA Emergency Use Authorization Submission of Extraction-Free Direct RT-PCR Test for COVID-19

World’s Simplest High-Throughput RT-PCR Test for COVID-19 has the potential to increase testing capacity by millions per week

Birmingham, AL, October 12, 2020 – 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™ the world with no refrigeration required.  Customers can request information on Xfree™ COVID-19 by contacting BioGX at covid19@biogx.com.

About BioGX

BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics.  BioGX, Inc., headquartered in Birmingham, Alabama, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively “BioGX”), operates in a cGMP compliant environment certified to ISO 13485 medical device development and manufacturing standards.  The proprietary Sample-Ready technology is at the core of all product offerings for Clinical, Food Safety, Pharma QC and Water Quality molecular testing.  BioGX B.V.’s 50+ molecular diagnostic products are marketed and sold in several countries through its Global Distribution Network.  

For more information on BioGX, please visit BioGX.com.

 

 

Sample-Ready, Just Add Water and Xfree are trademarks of BioGX, Inc.

BD MAX trademarks are property of Becton, Dickinson and Company (NYSE: BDX)

QIAamp is registered or pending trademark of QIAGEN Group (NYSE: QGEN)

QuantStudio 5 is a trademark of Thermo Fisher Scientific (NYSE: TMO)

Bio-Rad and Bio-Rad CFX96 Touch  is a trademark of Bio-Rad Laboratories, Inc. (NYSE: BIO)

 

Contact Information:

Robyn Martin-Schubart

Marketing Communications

+1.205.250.8055

marketing@biogx.com

BioGX launches CE-IVD Marked COVID-19, Influenza A/B, RSV Combo RT-PCR Test for the BD MAX™ System

Amsterdam, The Netherlands, 29 September 2020 – BioGX BV, the European subsidiary of Birmingham, Alabama based BioGX, announced availability of a CE-IVD marked test for simultaneous detection of SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus RNA in a patient sample using the BD MAX System.  

The test is offered in BioGX’s trusted, easy to use Sample-Ready format where all required reagents for real-time PCR are lyophilized in a single tube.  BioGX provided tube snaps into a test-specific position on the BD MAX total nucleic acid extraction cartridge enabling Sample-to-Answer molecular testing.  BioGX kits can be shipped anywhere in the world with no refrigeration required. 

“We are very pleased with the reliability and performance of this complex respiratory panel.  The simultaneous detection of COVID-19, Flu A, Flu B and RSV during Flu season would help further augment the BD MAX testing capacity by over 50,000 tests per week”, said Shazi Iqbal, Ph.D., CEO of BioGX.  

The BioGX multiplex COVID-19, Flu A, Flu B and RSV test is intended for qualitative detection of RNA specific to SARS-CoV-2,  Influenza A, Influenza B, and Respiratory Syncytial Virus A/B that may be present in Pharyngeal and Nasopharyngeal swab collections in transport media and saline, obtained from individuals at risk of respiratory viral infections.

The BD MAX System, commercialized by BD (Becton, Dickinson and Company), is a fully integrated and automated molecular diagnostic platform already in use at thousands of laboratories worldwide.  

The BioGX COVID-19, FluA, Flu B, RSV test is marketed and sold through BioGX BV’s Global Distribution Network as CE-IVD marked for In Vitro Diagnostic Use. The test is not available for sale or use in the U.S.A.  To locate an authorized distributor or request information, contact BioGX at info@biogx.com. 

About BioGX B.V.

BioGX B.V., based in Amsterdam, The Netherlands is a provider of molecular diagnostics reagents for infectious disease testing. It is a wholly owned subsidiary of BioGX, with corporate headquarters located in Birmingham, Alabama.

About BioGX

BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics.  BioGX, Inc., headquartered in Birmingham, Alabama, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively “BioGX”), operates in a cGMP compliant environment certified to International Standard ISO 13485. The company applies its proprietary Sample-Ready lyophilized technology to offer products and contract services across a variety of real-time PCR platforms. The Sample-Ready technology is at the core of all product offerings for Clinical, Food Safety, Pharma and Water Quality molecular testing.  BioGX B.V.’s 50+ molecular diagnostic products are marketed and sold in several countries through its Global Distribution Network. 

For more information on BioGX, please visit BioGX.com.

*BD and BD MAX trademarks are property of BD (Becton, Dickinson and Company).

Sample-Ready and Just Add Water are registered trademarks of BioGX, Inc.

BioGX And Bosch Healthcare Solutions Announce Partnership To Develop Infectious Disease Tests For The Vivalytic Platform

Birmingham, AL, and Stuttgart, Germany, May 26, 2020 – BioGX and Bosch Healthcare Solutions have partnered to develop point-of-care infectious disease tests for the Bosch Vivalytic, all-in-one, platform.

Read more

BD, BioGX Announce FDA Emergency Use Authorization For New COVID-19 Diagnostic For Use In U.S.

FRANKLIN LAKES, N.J. and BIRMINGHAM, Ala., April 3, 2020

BD (Becton, Dickinson and Company) a leading global medical technology company, and BioGX Inc., a molecular diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a new diagnostic test that will enable hospitals to screen for COVID-19 (coronavirus) on site and get results in under three hours. Read more

Becton Dickinson, BioGX Get FDA Emergency Use Authorization For Rapid SARS-CoV-2 Test

Becton Dickinson and BioGX announced Friday that they received Emergency Use Authorization from the US Food and Drug Administration for a hospital SARS-CoV-2 test. Read more

Becton Dickinson, BioGX Partner To Submit COVID-19 Test For US Emergency Use

NEW YORK – Becton Dickinson and BioGX said on Monday that they have submitted a test to detect SARS-CoV-2, the virus that causes COVID-19, that runs on the BD Max system to the US Food and Drug Administration for Emergency Use Authorization. If authorized, the test could potentially increase screening capacity in the US. Read more

BioGX Receives CE-IVD Mark For Enhanced Flu Assay

Amsterdam, The Netherlands, 22 October 2019 – BioGX B.V., the European subsidiary of Birmingham, Alabama based BioGX, announced it has received CE-IVD marking for its new Flu A, Flu B, RSV A/B automated test. The new test significantly enhances the strain coverage and detection sensitivity, and offers testing for a greater variety of specimen types compared to the initially released test. Read more

BioGX Celebrates Success Of Global Partnership Initiative, Announces New Distribution Partnerships In EMEA And Asia-Pacific

Amsterdam, The Netherlands, 01 November 2018 – Amsterdam-based BioGX B.V., a subsidiary of Birmingham, Alabama based molecular diagnostics company BioGX, today announced several new distribution partnerships in the EMEA and Asia-Pacific as it continues to expand its global presence. Read more

BioGX Launches 5 New CE Mark IVD Tests, Expands Number Of Sexual Health Panels

Amsterdam, The Netherlands, 23 October 2018 – BioGX B.V. recently released 5 new sexual health CE Mark IVD tests, expanding BioGX’s CE-IVD menu to a total of 21 multiplex panels, with additional test panels to be released before the end of 2018. Read more

BioGX Launches Six CE-Mark Tests For Meningitis And Antibiotic Resistance

Amsterdam, The Netherlands, 24 May 2018 – BioGX B.V. continues its *BD MAX menu expansion with the launch of six additional CE-Mark infectious disease tests on Becton, Dickinson and Company’s BD MAX Sample-to-Answer platform. This brings the company’s CE-Mark menu for the BD MAX to eleven tests, with an additional ten planned for the second half of 2018. Read more