Xphyto Therapeutics (XPHY.C) diagnostic partner, 3a-Diagnostics GmbH, is getting onboard with the latest rush to develop a COVID-19 diagnostic kit, using reverse transcription polymerase chain reaction (RT-PCR) technology, which brings anticipated results in 25 minutes, according to a press release.
The test is planned for commercial launch as a CE-IVD-certified (in vitro diagnostic) product in the European Union by Q1, 2021.
“Applying 3a’s proprietary enhanced RNA technology to PCR testing was a logical next step in our product development pipeline. 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,” said Dr. Heinrich Jehle, managing director of 3a-Diagnostics.
The final validation studies for both RNA test systems are going to take place in Germany in Q4, 2020. 3a will continue with its industrial design, product usability, labelling compliance, regulatory approval and production planning work as its doing its validation studies.
Xphyto announced an agreement signed with 3a Diagnostics on April 20, 2020, that deal with a technology purchase and licensing agreement to develop and commercialize a real-time, inexpensive, user-friendly screening test using their 3a’s pathogen-specific biosensor and Xphyto’s oral dissolvable drug delivery system.
In July, 2020, they tacked on an addition to the agreement that includes 3a’s RNA system and related intellectual property into the agreement, and also includes exclusive commercial rights for the rapid test and RT-PCR test.