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XPhyto Therapeutics, 3a-diagnostics Obtain CE Mark for 25-Minute SARS-CoV-2 PCR Test

NEW YORK ─ XPhyto Therapeutics and 3a-diagnostics said on Thursday that they have obtained the CE mark for a point-of-care SARS-CoV-2 RT-PCR test system, called Covid-ID Lab.

Covid-ID Lab, a multiplex viral RNA kit, requires a 20-minute PCR thermal cycle without prior RNA extraction for sample preparation and can be performed by many PCR instruments, XPhyto said. The elimination of RNA extraction for sample preparation reduces the risk of cross contamination and minimizes the need for lab materials and trained personnel, the firm added.

The tests consist of optical indicator strips on a fluidics platform that provides results after a single PCR cycle.

"With a sample collection to result time of 25 minutes, Covid-ID Lab combines the speed of a rapid screening test with the accuracy of a PCR diagnostic," XPhyto CEO and Director Hugh Rogers said in a statement. "Covid-ID Lab is designed for point-of-care testing, particularly in satellite and small-scale labs, such as transportation hubs, borders, care facilities, schools, pharmacies, and hospitality settings."

Vancouver, British Columbia-based XPhyto said it is in discussions with potential distribution and wholesale partners as well as potential licensees, and in April, it expects to begin selling the test in Europe.

Frickenhausen, Germany-based 3a-diagnostics is XPhyto's exclusive German diagnostics development partner.