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XPhyto Therapeutics Corp.: XPhyto announces European Approval for 25 Minute COVID-19 PCR Test

DGAP-News: XPhyto Therapeutics Corp. / Key word(s): Miscellaneous XPhyto Therapeutics Corp.: XPhyto announces European Approval for 25 Minute COVID-19 PCR Test 18.03.2021 / 09:05 The issuer is solely responsible for the content of this announcement. XPhyto announces European Approval for 25 Minute COVID-19 PCR Test

- CE Mark received for in vitro diagnostic (IVD) test for the detection of SARS-CoV-2

- Rapid results with ease of use - single 20-minute PCR cycle plus 5-minute detection process

- High sensitivity - 104.73 c/PCR limit of detection with 95% confidence interval

- High specificity - zero cross-reactivity on 19x respiratory infectious disease panel

- High robustness - no impact on results from minor changes in process parameters

- 100% repeatability and laboratory precision observed

- Sales launch in Europe planned for April 2021

VANCOUVER, BC / ACCESSWIRE / March 18, 2021 / XPhyto Therapeutics Corp. (CSE:XPHY)(OTC:XPHYF)(FSE:4XT) ("XPhyto" or the "Company"), and its exclusive German diagnostics development partner, 3a-diagnostics GmbH ("3a"), are pleased to announce the European approval of its point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system ("Covid-ID Lab"). Covid-ID Lab is now registered within the European Union as a commercial in vitro diagnostic (CE-IVD) test.

"Our test is one of the fastest PCR-based COVID-19 tests currently approved. 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," said Hugh Rogers, CEO and Director of XPhyto. "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."

Covid-ID Lab is a multiplex viral RNA probe kit based on the reverse transcriptase-polymerase chain reaction (RT-PCR) method. For assay performance, Covid-ID Lab requires only a single 20-minute PCR thermal cycle without prior RNA extraction as part of the sample preparation. Many widely available standard PCR instruments are suitable to run the test. Results are collected after the PCR cycle via easy-to-read optical indicator strips on a simple fluidics platform. 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 rapid results, minimal laboratory equipment, and ease of use are expected to translate into reduced operating costs, greater convenience and portability.