BioGX Expands FDA EUA with pixl™ Portable qPCR System for its Direct-Sample COVID-19 Assay

Birmingham, Alabama, Nov 10, 2022 – 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 XfreeTM 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’s pixlTM real-time PCR platform.

 

The innovative BioGX XfreeTM 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 pixlTM 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.

 

“With 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,” said Shazi Iqbal, Ph.D., CEO of BioGX.

View Original Press Release at:

https://www.businesswire.com/news/home/20221110006045/en/BioGX-Expands-FDA-EUA-with-pixl%E2%84%A2-Portable-qPCR-System-for-its-Direct-Sample-COVID-19-Assay

BioGX Announces Availability of Xfree PCR Reagents for Monkeypox

BIRMINGHAM, Ala.–(BUSINESS WIRE)–To address the growing need for simplified, rapid testing for Monkeypox, BioGX, a global provider of easy molecular diagnostic solutions, announced availability of Xfree PCR reagents for Sample-to-Answer Direct Sample PCR on multiple real-time PCR platforms including BioGX’s rapid “pixl” platform.

Dr. Suzane Silbert, Director, Esoteric Testing/R&D and Microbiology Laboratories at Tampa General Hospital (TGH) said, “We validated the BioGX Xfree hMPXV/OPXV custom manufactured reagents as Laboratory Developed Test on two platforms, BioGX’s pixl real-time PCR instrument and another Sample-to-answer Open System platform. The test is robust and showed excellent performance on both platforms with pixl having an advantage of a small footprint and providing 3x faster results.” She further added, “Prior to sourcing the reagents from BioGX, TGH was sending tests to an external reference laboratory with much longer turnaround time and higher costs.”

“BioGX Monkeypox Xfree PCR reagents validated by TGH leverages the highly successful Xfree extraction-free direct sample testing chemistry that is also included in the BioGX EUA Xfree COVID-19 Direct RT-PCR test,” said Robert Martinez, Ph.D., Sr. Director of Scientific Affairs & Strategic Partnerships. He further noted, “BioGX Monkeypox reagents incorporate the US CDC primer/probe designs to detect West African and Central African (Congo Basin) clades of the Monkeypox virus, and separately screen for non-variola Orthopox viruses.”

BioGX’s Xfree Direct Sample PCR reagents offer the flexibility to validate testing using a direct swab collection at point-of-care or a swab sample collected in transport media such as Copan UTM®, Copan ESwab, Viral Transport Media or Phosphate Buffered Saline, completely bypassing the need for additional equipment and consumables for sample processing and extraction, saving both time and money.

View Original Press Release at:

https://www.businesswire.com/news/home/20221020005913/en/BioGX-Announces-Availability-of-Xfree-PCR-Reagents-for-Monkeypox

BioGX Launches CE-IVD Marked Multi-gene COVID-19 Point-of-Care Test at AACC

CHICAGO–(BUSINESS WIRE)–BioGX, a global provider of easy molecular diagnostic solutions, announced the launch of a point-of-care (POC) CE-Marked, three gene multiplex COVID-19 test on its pixl platform.

The test utilizes BioGX’s highly successful Xfree direct sample testing chemistry that is included in its US FDA emergency use authorized Xfree COVID-19 Direct RT-PCR test. This new multi-gene COVID-19 test targets the N1, RdRp and M gene regions for greater redundancy in detecting SARS-CoV-2 emerging variants.

This innovative POC test is simple to use and only requires the addition of one drop of sample added directly to the freeze-dried Xfree chemistry.

The BioGX pixl16 is a small, portable, 4-channel, 16-well real-time PCR platform that supports turnaround times of less than an hour for up to 16 samples. Results interpretation and reporting are integrated within the easy-to-use touchpad-based pixl instrument.

“Pixl combined with our unique Xfree chemistry offers our customers the ease-of-use and affordability of antigen-based testing with the superior sensitivity and specificity of real-time PCR testing”, said Shazi Iqbal, CEO of BioGX.

Building upon the success of its Xfree direct sample addition technology, BioGX is developing a pipeline of Xfree-pixl tests that will enable simple and affordable POC PCR testing. As with all BioGX tests, the Xfree COVID-19 3-gene Direct Sample RT-PCR kits ship globally at ambient temperature.

About BioGX

BioGX 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 “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’s 60+ multiplex real-time PCR products are marketed and sold in several countries through its Global Distribution Network.

View Original source at https://www.businesswire.com/news/home/20220727006080/en/BioGX-Launches-CE-IVD-Marked-Multi-gene-COVID-19-Point-of-Care-Test-at-AACC

BioGX COVID-19 Tests Detect Omicron SARS-CoV-2 Variant

Xfree™ COVID-19 Direct RT-PCR Test

BIRMINGHAM, Ala.–(BUSINESS WIRE)–BioGX, a global provider of molecular diagnostic solutions, announced that the Omicron (B.1.1.529), the latest emerging SARS-CoV-2 variant of concern, will be detected by the portfolio of BioGX SARS-CoV-2 products that target the nucleocapsid (N-gene) and envelope (E-gene) for detection of the virus.

BioGX’s SARS-CoV-2 surveillance program includes exhaustive in-silico analysis and experimental testing by BioGX scientists using RNA sequences containing the mutations present within the emerging SARS-CoV-2 variants. The analysis conducted by BioGX confirmed the BioGX portfolio of COVID-19 tests maintain detection coverage for all variants of interest and variants of concern, including the new Omicron variant.

BioGX offers a portfolio of COVID-19 RT-PCR tests for a variety of real-time PCR platforms, including BD MAX™ System, Applied Biosystems™ 7500 Fast Dx, Applied Biosystems™ QuantStudio™ 5, Bio-Rad CFX96 Touch™ and Bio-Rad CFX384 Touch™. Details of each test are available at BioGX.com. Within the BioGX portfolio, the Xfree COVID-19 Direct RT-PCR is the most popular test because of its ease-of-use and flexibility for high throughput applications. To perform the RT-PCR testing, the user simply rehydrates the lyophilized Xfree reagent with molecular grade water, adds the patient sample, and runs the test on a validated real-time PCR instrument. Xfree COVID-19 is the only lyophilized, direct sample addition, extraction-free, RT-PCR test to receive FDA emergency use authorization for a variety of widely available real-time PCR instruments and specimen types. Additionally, the test is authorized to run with extracted samples, offering options for the laboratory to adapt the test for any laboratory workflow.

Customers can request information by contacting BioGX at Ph: +1.205.250.8055 or sales@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 Dallas, TX, 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’s 60+ multiplex real-time PCR products are marketed and sold worldwide through its Global Distribution Network.

 

View Original source at https://www.businesswire.com/news/home/20211206005557/en/BioGX-COVID-19-Tests-Detect-Omicron-SARS-CoV-2-Variant

 

BioGX Receives FDA EUA for a Novel, High-Throughput, Direct Sample RT-PCR Test for COVID-19

Xfree™ COVID-19 Direct RT-PCR TestBirmingham, Alabama, July 01, 2021 – BioGX, a global provider of molecular diagnostic solutions, announced that the United States Food and Drug Administration has issued Emergency Use Authorization (EUA) for their breakthrough direct sample addition, Xfree COVID-19 test. Xfree COVID-19 is a complete test lyophilized in a single tube, for extraction-free, direct sample addition real-time RT-PCR testing.  The Xfree COVID-19 test eliminates all upfront sample processing steps and enables clinical laboratories to generate high-throughput Sample-to-Answer results using widely available real-time PCR platforms. 

 

Matthew Beckman, Ph.D., Director of Laboratory Services at GENETWORx said, “The staff at GENETWORx has been very pleased with the performance of the BioGX Xfree COVID-19 test. In our studies, the test performed superior to other SARS-CoV-2 tests we evaluated in head-to-head comparisons. BioGX test is very simple to use while providing increased quality assurance of well-by-well monitoring of the PCR reaction. The product also offers the consistency and platform flexibility to rapidly increase throughput without needing to invest in additional resources and new systems.”

 

Our test not only enables laboratories of all sizes to perform high-performance cost-effective testing, but also provides robust strain coverage for all prevalent strains, including the rapidly spreading Delta variant”, said Shazi Iqbal, Ph.D., CEO of BioGX. “The FDA authorization of our Xfree chemistry paves the way for us to leverage our expansive menu of tests to create an Xfree line of point-of-care (POC) tests for respiratory and urinary tract infections”, he added.     

 

The FDA has authorized the Xfree COVID-19 test with broad specimen coverage to include nasopharyngeal, anterior nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate and nasal aspirates. Additionally, the test is authorized to run with extracted samples offering options for the laboratory to adapt the test in any laboratory workflow. The test is already in use in several laboratories and costs $7-12 per sample depending on its use as direct sample addition or with extracted sample.    

 

Xfree is a complete test in a single vial, lyophilized in the trusted BioGX Sample-Ready format. To perform the RT-PCR test, the user simply rehydrates the lyophilized test with molecular grade water, adds a patient sample, and runs the test on a validated real-time PCR instrument. The test can be shipped anywhere in the world without refrigeration.  

Customers can request information on Xfree COVID-19 by contacting BioGX at Ph: +1.205.250.8055 or sales@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 Dallas, TX, 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’s 60+ multiplex real-time PCR 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.

BioGX Sample-Ready™ technology launches into Space yet again, aboard the International Space Station.

BioGX reagents aboard the ISSBIRMINGHAM, ALABAMA, 03 March 2021 – BioGX Sample-Ready™ lyophilized qPCR technology was selected by the NASA WetLab-2 program in 2016 to conduct genetic analysis in a microgravity environment aboard the International Space Station (ISS). Five years and several launches later, the collaboration is still going strong with a track record of success. 

The International Space Station (ISS) is the world’s leading laboratory for cutting-edge research and innovation.  “We are proud to be NASA’s partner in their quest for high-performing, innovative molecular chemistries.  Our outer space innovations find their way in creating best in class molecular diagnostics solutions for any lab setting, here on earth” said Shazi Iqbal, Ph.D., CEO of BioGX.

 

BioGX support was essential for the successful launch of the latest One-Step Gene sampling tool for genetic analysis on the ISS. At the core of this technology is a microscopic probe for rapid and single-step purification of RNA from biological specimens using a pin interface with the Cepheid SmartCycler instrument that is currently on the ISS. The One-Step Gene Sampler was developed in a collaboration between Dr. Gergana G. Nestorova (Louisiana Tech University, Ruston, LA), Dr. Niel Crews (nou Systems Inc, Huntsville, AL), and the WetLab-2 team at NASA ARC. The latest batch of BioGX Sample-Ready™  lyophilized reagents and the One-Step Gene Sampler were launched on Space-X21 in December,2020 and are scheduled for testing this month.

 

“BioGX worked with us to develop a custom-designed lyophilized mixture for the reverse-transcription PCR experiment in orbit. The company provides our reagents in a ready-to-use format, customized in SmartCycler tubes that require only the addition of water before the actual genomic experiment in orbit.  The reverse-transcription PCR reagents supplied by BioGX provide excellent sensitivity and reproducibility.  Due to the constraints of performing experiments in space, the traditional liquid suspension format of PCR reagents is not appropriate for delivery to the ISS. Therefore, the lyophilization method developed by BioGX is essential for the preparation of PCR reagents for launch and storage in orbit.” said Dr. Gergana G. Nestorova of Louisiana Tech University, Ruston, LA.

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.

Additional links: www.nestorovalab.com

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.

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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