Aug 9, 2020 in Diagnostics, Press Releases

XPhyto Provides Update On COVID-19 Rapid Test

Vancouver, Canada (August 10, 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, near-term milestones and the pathway to commercialization.

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 and nasal and throat swabs (the “Test”). On July 6, 2020, the Company announced successful validation of its working prototype for concurrent and independent detection of both the COVID-19 virus and viruses in the broader coronavirus family. 3a’s enhanced RNA probe system has demonstrated a detection limit capable of identifying viral RNA at concentrations found in the saliva of symptomatic, pre-symptomatic, and asymptomatic patients as observed and reported by clinicians and scientists in peer reviewed publications.1,2,3

Test prototype with a positive signal
Test prototype with a positive signal

Figure 1. A photograph of the Test prototype with a positive signal for both COVID-19 RNA (genome sequence specific to SARS-COV-2) and universal coronavirus RNA (genome sequence shared across the coronavirus family). From left to right: Signal 1: COVID-19 probe, Signal 2: universal coronavirus probe, and Signal 3: control. The above results were visually confirmed in less than 5 minutes.

Test development and optimization is proceeding on an expedited basis at 3a’s research lab in Germany and in collaboration with third party contractors and academic partners. Subject to fast track certification by the German government, XPhyto and 3a are targeting Q1 2021 for European regulatory approval and commercial sales pursuant to the following estimated work schedule:

Development and commercialization milestones
Development and commercialization milestones

Three potential risk factors have been identified that could negatively impact the estimated schedule of milestones: 1) general internal and/or third party delays; 2) delays related to adjustments for usability optimization; and 3) delays associated with the ISO 13485 audit. XPhyto and 3a are actively working to mitigate delay risks and accelerate the estimated schedule wherever possible. The Company will provide ongoing milestone updates, including regarding clinical evaluation, in due course and as appropriate.

XPhyto and 3a are developing rapid screening tests for COVID-19 and other pandemic threats, including H1N1 (swine flu) and H5N1 (avian flu), with a specific focus on early pre-symptomatic stages of infection. Screening tests include later flow assay type tests as well as next-generation biosensors delivered via XPhyto’s dissolvable oral drug delivery platform. The product pipeline is comprised exclusively of rapid, low-cost, easy-to-use, saliva-based screening tools that can be self-administered, making them ideal for decentralized population scale screening. Please join us today, Monday, August 10, 2020, for a live presentation at 12:30 PM EST: 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 Wölfel, R., Corman, V.M., Guggemos, W. et al. Virological assessment of hospitalized patients with COVID-2019. Nature 581, 465–469 (2020).
2 He, X., Lau, E.H.Y., Wu, P. et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med 26, 672–675 (2020).
3 To KK, Tsang OT, Leung WS, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 20(5), 565-574 (2020).

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