Entries by Robyn Martin-Schubart

BioGX Lambda and Mu Variant Update

Lambda and Mu Variant Update – 13 September 2021 On June 14th and August 30th the WHO recognized two SARS-CoV-2 strains (“Lambda” and “Mu”) as variants of interest (VoI). Lambda and Mu were both first identified in South America and to date there have been over 6,344 and 5,752, respectively, sequences deposited in GISAID and NCBI […]

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

Birmingham, 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 […]

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

BIRMINGHAM, 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 […]

BioGX finds a new home in Shelby County

Birmingham-based molecular diagnostics company BioGX has purchased a building on Valleydale Road in Shelby County that will house its corporate headquarters and expanded research and development and manufacturing capabilities. The company will progress from its current location at the Innovation Depot and move to the new facility in several phases in 2021, making an investment […]

New Strains. No Problem.

Californian L452R mutation. As new strains of SARS-CoV-2 are identified across the globe, we will supply an update related to the coverage of BioGX COVID-19 assays. On January 18, 2021, BioGX performed in silico analysis of the primer and probes used for SARS-CoV-2 diagnostics using the N1- and N2-gene regions.  A total of 793 SARS-CoV-2 […]

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 […]

Fully-Automated Workflow for COVID-19 & Winter Virus Testing

The BioGX multiplex COVID-19, Flu A, Flu B and RSV test is intended for the 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. […]

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 […]

BioGX: Expanding to help protect people around the world

The American MedTech firm BioGX is supplying coronavirus test kits worldwide from its global office and lab in Amsterdam Science Park. “Everyone is coming together to help, they recognise the importance of mass testing,” CEO Dr Shazi Iqbal explains to I amsterdam how the company is working to fight the global coronavirus outbreak. Full article […]

Combat the spread of infectious disease 

The past few months has shown that a team’s rapid response to expediting an assay globally, dedicated  to the detection of SARS-CoV-2, is possible. BioGX, in a long-term partnership with Becton, Dickinson  and Company, has submitted a test to the FDA for emergency use authorisation (EUA) in the US, in  parallel to CE-IVD approval. In […]