Sep 8, 2020 in Diagnostics, Press Releases
Update On COVID-19 Rapid Test Commercialization
Vancouver, Canada (September 8, 2020) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”), a next generation bioscience company, is pleased to announce an update on its rapid COVID-19 (SARS-CoV-2) screening test.
XPhyto and its exclusive diagnostic partner, 3a-Diagnostics GmbH (“3a”), are developing a rapid, disposable, point-of-care lateral flow screening test to detect COVID-19 viral RNA from patient saliva samples and nasal and throat swabs (the “Test”). On July 6, 2020, the Company announced successful validation of its working prototype to concurrently detect the COVID-19 virus and viruses in the broader coronavirus family (including SARS-CoV and MERS-CoV). On August 10, 2020, the Company announced commercial milestones targeting European regulatory approval in Q1 2021.
3a has taken possession of COVID-19 RNA isolated from live viable virus for its second round of proof of concept prototype testing. This evaluation process is currently underway and results are expected within 30 days. Pending successful evaluation results the Company will proceed to advanced prototype production and usability testing scheduled for Q4 2020. Test development and optimization continues to proceed on an expedited basis at 3a’s research lab and in collaboration with third party contractors and academic partners in Germany.
“In general, the scientific understanding of the COVID-19 virus and an active infection is rapidly evolving. It’s a dynamic situation but XPhyto is bolstered by the emerging scientific literature that supports the use of saliva tests over nasopharyngeal swabs and molecular (RNA) tests over other forms of detection, which may be susceptible to false negatives,” said Hugh Rogers, CEO of XPhyto.1,2
XPhyto and 3a are developing rapid screening tests for COVID-19 and other high-risk pandemic threats, including H1N1 (swine flu) and H5N1 (avian flu), with a specific focus on early presymptomatic and asymptomatic stages of infection. H1N1 and H5N1 development programs are currently funded through grants from the German Federal Ministry of Education and Research. The Company’s screening tests include enhanced RNA-probe lateral flow assay tests as well as novel biosensors delivered via XPhyto’s oral dissolvable drug delivery platform. The product pipeline is comprised exclusively of next generation rapid, low-cost, easy-to-use, saliva-based screening tools designed to be self-administered, making them ideal for decentralized population-scale screening.
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.
1 Wyllie, A., Fournier, J., Casanovas-Massana, A. et al. Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2. New England Journal of Medicine, Correspondence To the Editor (2020, August 28).
2U.S. Food & Drug Administration. (2020, August 26) COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card [Press Release]. Retrieved from: https://www.fda.gov/newsevents/press-announcements/covid-19-update-fda-authorizes-first-diagnostic-test-where-results-can-be-readdirectly-testing-card.