XPhyto Therapeutics pursues market access in Israel for its rapid 25-minute Covid-ID Lab test

XPhyto Therapeutics Corp (CSE:XPHY) (OTCQB:XPHYF) (FRA:4XT) revealed that it has delivered 2,000 of its 25-minute coronavirus (COVID-19) RT-PCR test kits called Covid-ID Lab to an established medical distributor in Israel to clinically evaluate the test and pursue commercial regulatory approval.

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, said the company.

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.

READ: XPhyto Therapeutics takes ‘critical’ step towards commercial sales of Covid-ID Lab test in Germany

“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,” XPhyto CEO Hugh Rogers said in a statement. “We expect that rapid and accurate diagnostic testing will remain a primary tool for pandemic management and monitoring for many years to come.”

The unnamed Israeli distributor markets 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,” said the company.

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.

The elimination of RNA extraction for sample preparation reduces cross-contamination risk and minimizes the need for lab materials and trained personnel, noted the bioscience company. The rapid results, minimal lab equipment, and ease of use are expected to translate into reduced operating costs and more convenience.

“XPhyto is currently in discussions with various potential customers, distribution and wholesale partners as well as potential licensees,” said the company. It noted that a sales launch in Europe is targeted for the second quarter of 2021.

XPhyto has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive

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