XPhyto Announces RT-PCR Test For Point-Of-Care COVID-19 Detection
- 25-minute RT-PCR lab test to complement 15-minute rapid test
- European market launch of both COVID-19 tests planned for Q1 2021
Vancouver, Canada (October 28, 2020) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”), a next-generation bioscience accelerator, is pleased to announce that its exclusive diagnostic partner, 3a-Diagnostics GmbH (“3a-Diagnostics” or “3a”), is developing a reverse transcription polymerase chain reaction (“RT-PCR”) kit targeting COVID19 (SARS-CoV-2) diagnostic results in 25 minutes. The test is planned for commercial launch as a
CE-IVD (in vitro diagnostic) certified product in the European Union in Q1 2021. “Applying 3a’s proprietary enhanced RNA technology to PCR testing was a logical next step in our product development pipeline,” said Dr. Heinrich Jehle, managing director of 3a-Diagnostics. “We are currently developing two saliva-based tests to detect SARS-CoV-2 RNA. The RT-PCR test system is to be employed in a laboratory setting using minimal equipment with sample-to-results in less than 25 minutes. The rapid test system is a low cost, self-administered, disposable test with sample-to-results in less than 15 minutes. Both systems are on track for European commercialization in Q1 2021.”
Final validation studies are planned to be carried out for both RNA test systems in Germany in Q4 2020. 3a will continue to advance its industrial design, product usability, labelling compliance, regulatory approval, and production planning work in parallel to its validation studies. On April 20, 2020, XPhyto announced a definitive development, technology purchase and licence agreement with 3a-Diagnostics for the development and commercialization of real-time, lowcost and easy-to-use screening tests using 3a’s pathogen specific biosensors and XPhyto’s oral dissolvable drug delivery platform. On July 1, 2020, 3a and the Company signed an addendum to the agreement which incorporates 3a’s proprietary enhanced RNA system and related IP into the agreement which includes exclusive commercialization rights for the rapid test and RT-PCR test.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 pandemic.