- XPhyto delivered 2,000 of its 25-minute PCR tests to Israeli distributor for clinical evaluation and regulatory approval
- Potential customers include government institutions, private healthcare providers and neighboring countries
Vancouver, Canada (April 28, 2021) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to announce that it has delivered 2,000 of its rapid 25-minute PCR tests (“Covid-ID Lab”) to an established medical distributor in Israel for clinical evaluation of Covid-ID Lab for the purpose of commercial regulatory approval and potential product distribution.
Based on the European CE-IVD approval of Covid-ID Lab, announced by the Company on March 18, 2021, Covid-ID Lab will be evaluated by the Medical Device Division of the Israeli Ministry of Health (AMAR) for the purpose of securing Israeli regulatory approval. Israel recognizes several international medical device certifications including the European CE-IVD mark. The clinical evaluation process is expected to be complete in less than 90 days and will form the basis for commercial approval of Covid-ID Lab in Israel.
The Israeli distributor markets and distributes a range of medical products, including diagnostics, in Israel and surrounding Middle Eastern countries. Its customers include government and private institutions such as hospitals, pharmacies and a broad range of health care providers.
“We are excited by the opportunity to expand potential distribution beyond Germany. We are building strong partnerships around the world and Israel is a leading nation for COVID-19 management and research,” said Hugh Rogers, CEO and Director of XPhyto. “We expect that rapid and accurate diagnostic testing will remain a primary tool for pandemic management and monitoring for many years to come.”
Covid-ID Lab is a multiplex viral RNA probe kit based on the reverse transcriptase-polymerase chain reaction (RT-PCR) method. Covid-ID Lab requires only a single 20-minute PCR thermal cycle for assay performance without prior RNA extraction as part of the sample preparation. Many widely available standard PCR instruments are suitable to run the test. Results are collected after the PCR cycle via easy-to-read optical indicator strips on a simple fluidics platform. The elimination of RNA extraction for sample preparation reduces cross-contamination risk and minimizes the need for lab materials and trained personnel. The rapid results, minimal laboratory equipment, and ease of use are expected to translate into reduced operating costs, greater convenience and superior portability.
XPhyto is currently in discussions with various potential customers, distribution and wholesale partners as well as potential licensees. The sales launch in Europe is targeted for Q2 2021. The Company will provide further information and updates in due course.
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.