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XPhyto Therapeutics Corp.: XPhyto Pursues Market Access in Israel for its COVID-19 PCR Rapid Test
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, BC / ACCESSWIRE / April 28, 2021 / XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB: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 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, BC / ACCESSWIRE / April 28, 2021 / XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB: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.
Habe gestern die folgende Frage an das Unternehmen gerichtet und folgende Antwort erhalten (Quelle: Twitter):
Thank you; great news ! Do you have any information for us when deliveries will start ?
We're working with several German and international distributors to build a sustainable diagnostics business. We're pushing forward on European and Middle Eastern fronts and expect to make a number of announcements in Q2 2021 regarding distribution and sales. Stay tuned!
Thank you; great news ! Do you have any information for us when deliveries will start ?
We're working with several German and international distributors to build a sustainable diagnostics business. We're pushing forward on European and Middle Eastern fronts and expect to make a number of announcements in Q2 2021 regarding distribution and sales. Stay tuned!
Das habe ich schon vor einiger Zeit gesagt wenn alle Durchgeimpft sind bringen Sie die Tests auf den Markt.
Antwort auf Beitrag Nr.: 67.964.768 von Fussel629 am 27.04.21 16:01:39Immer die gleiche Frage zu stellen bringt irgendwie auch nx, Fussel.
Der April ist bald um
Mal gucken ob die es noch bis Ende des Monats wie angekündigt schaffen
Mal gucken ob die es noch bis Ende des Monats wie angekündigt schaffen
PCR Tests braucht man sicher noch ein Weile; aber Geschwindigkeit kann jetzt nicht schaden ;-)
Verstehe ich auch nicht. Gute Produkt. Leider etwas zu spät auf den Markt. Aber PR Katastrophe!
Eigentlich müssten ja mal Umsätze kommen. Würde mich freuen wenn die über erste Lieferungen an ihren deutschen Vertriebspartner berichten könnten.
..... ja so richtig kommt hier nichts ?!
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