XPhyto Therapeutics Corp (CSE:XPHY) (OTCPINK:XPHYF) (FRA:4XT) revealed on Wednesday that its exclusive diagnostic partner 3a-Diagnostics GmbH, is developing a reverse transcription polymerase chain reaction (RT-PCR) kit targeting coronavirus (COVID-19) diagnostic results in 25 minutes.
The Vancouver-based next-generation bioscience accelerator said that the test is planned for commercial launch as a CE-IVD (in vitro diagnostic) certified product in the European Union by the first quarter of 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, who is managing director of 3a-Diagnostics.
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"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.”
Dr Jehle noted that 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," he added.
Final validation studies are planned to be carried out for both RNA test systems in Germany in the fourth quarter this year. 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 this year, XPhyto announced a definitive development, technology purchase and licence agreement with 3a-Diagnostics for the development and commercialization of real-time, low-cost and easy-to-use screening tests using 3a's pathogen-specific biosensors and XPhyto's oral dissolvable drug delivery platform.
In July, 3a and XPhyto 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.
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