Molecular diagnostic solutions provider BioGX has secured emergency use authorisation (EUA) from the US Food and Drug Administration for its Xfree Covid-19 test.

The Xfree COvid-19 is a complete test lyophilised in a single tube for extraction-free and direct sample addition real-time RT-PCR testing.

Designed to avoid all upfront sample processing steps, the Covid-19 test allows clinical laboratories to offer high-throughput sample-to-answer results using real-time PCR platforms.

For conducting the test, the user has to rehydrate the lyophilised test with molecular grade water, add a patient sample and run the test on a validated real-time PCR instrument.

BioGX CEO Dr Shazi Iqbal said: “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.

“The FDA authorisation 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 authorisation allows to use the Xfree Covid-19 test with a broad specimen range, including nasopharyngeal, anterior nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate and nasal aspirates.

The test is also approved to run with extracted samples, providing options for a laboratory to adapt the test in any laboratory workflow.

BioGX stated that the Xfree Covid-19 test is already in use in various laboratories.

In September last year, the company launched 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.