As you can see above, this company is not messing around and has been hard at work advancing multiple diagnostic products/drugs/treatments towards completion.
None may be more important than the one at the top, Rapid RT-PCR.
CV-19 RT-PCR Diagnostic Test
- Rapid test in 25 minutes
- 5 min hands-on time and 20 mins reaction only
- Point of care diagnostic device
- for use with minimal lab equipment
- Low detection limit
- diagnostic reliability of PCR tests
- Cost-effectiveness
- Easily accessible
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And, major news regarding this diagnostic product and more could become major catalysts for this company moving forward. Here's what you need to know:
#1. Potential XPHYF Catalyst - European Approval News
XPhyto announces European Approval for 25 Minute CV19 PCR Test
- CE Mark received for in vitro diagnostic (IVD) test for the detection of SA-RS-Co-V-2
- Rapid results with ease of use - single 20-minute PCR cycle plus 5-minute detection process
- High sensitivity - 104.73 c/PCR limit of detection with 95% confidence interval
- High specificity - zero cross-reactivity on 19x respiratory infectious disease panel
- High robustness - no impact on results from minor changes in process parameters
- 100% repeatability and laboratory precision observed
- Sales launch in Europe planned for April 2021
VANCOUVER, BC / ACCESSWIRE / March 18, 2021 / XPhyto Therapeutics Corp. (CSE:XPHY)(OTC:XPHYF)(FSE:4XT) ("XPhyto" or the "Company"), and its exclusive German diagnostics development partner, 3a-diagnostics GmbH ("3a"), are pleased to announce the European approval of its point-of-care SA-RS-Co-V-2 (CV-19) RT-PCR test system ("CV-ID Lab"). CV-ID Lab is now registered within the European Union as a commercial in vitro diagnostic (CE-IVD) test.
"Our test is one of the fastest PCR-based CV19 tests currently approved. With a sample collection to result time of 25 minutes, CV-ID Lab combines the speed of a rapid screening test with the accuracy of a PCR diagnostic," said Hugh Rogers, CEO and Director of XPhyto. "CV-ID Lab is designed for point-of-care testing, particularly in satellite and small-scale labs, such as transportation hubs, borders, care facilities, schools, pharmacies, and hospitality settings."
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During validation of the assay, the limit of detection for SA-RS-Co-V-2 RNA was determined to be 104.73 c/PCR within a 95% confidence interval. Specificity of 100% against 19 other pathogens of serious respiratory infections was demonstrated on a respiratory verification panel. Precision was determined through evaluation of variance of the analysis results due to random deviations, a repeatability/intra-assay precision evaluation (same lab, user, equipment, etc.), and a laboratory precision evaluation (different lab, user, equipment, etc.). Robustness was measured by evaluation of the impact of minor changes on process parameters (transport medium, PCR cycler model, ramp rate, template volume, hybridization mixing ratio, etc.). The validation studies were carried out accordingly to ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology and VQ-015 Validation of Methods, European Medicines Agency. The quality management system was in accordance with EN ISO 13485: 2016 and EN ISO 9001: 2015.
XPhyto is currently in discussions with various potential distribution and wholesale partners as well as potential licensees. The sales launch in Europe is targeted for April 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 CV pandemic.
Read the full article here.
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#2. Potential XPHYF Catalyst - Establishing Proof Of Concept Station
XPhyto Establishes Proof of Concept Station for Point-of-Care 25-minute CV19 PCR Test in Germany
- Pilot project includes point-of-care sample collection, PCR processing and final testing of workflow logistics
- Project is in cooperation with a German pharmacy currently running a CV test center
- Rapid results with high accuracy - 20-minute PCR run plus 5-minute detection process
VANCOUVER, BC and FRANKFURT, GERMANY / ACCESSWIRE / May 7, 2021 / XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)( FSE:4XT) ("XPhyto" or the "Company") is pleased to announce it has commenced a pilot project with its rapid CV19 PCR test ("CV-ID Lab") in a point-of-care (POC) setting in Germany. The CV-ID Lab test was recently approved in Europe and offers the accuracy of a PCR test in only 25 minutes. During the pilot project, the validated work flows for the test including the mobile collection and processing of patient samples will be further optimized. XPhyto's clinical partner for the project is Spitzweg Apotheke, a well-known pharmacy in Langen near Frankfurt a. M., Germany, currently running a CV test center at a clinic, where it also provides special pharmacy services for cancer patients.
"With a specialized oncology pharmacy, many of our customers are in the CV high-risk group. For these patients, their families and their close contacts, fast and reliable diagnostics are critical to ensure everyday safety," commented Gabor Perl, Head of the Spitzweg pharmacy. "PCR tests are the diagnostic gold standard for CV. They provide high sensitivity and specificity. We are pleased to take part in this pilot project and now offer our high-risk-group customers access to a rapid PCR test with immediate results. We believe this is an opportunity for best-in-class healthcare delivery."
The laboratory equipment required for the project is installed and operating. The pharmacy professionals responsible for processing samples using CV-ID Lab have successfully completed all necessary training.
"Offering CV-ID Lab to patients in Germany is a significant milestone. The test has gone from concept to commercial use in less than twelve months," said Hugh Rogers, XPhyto CEO and Director. "CV-ID Lab is designed to be one of the fastest and most portable PCR systems in the world. Adapting CV-ID Lab to a POC setting is a major commercial opportunity for our German subsidiary XP Diagnostics."
CV-ID Lab is a rapid RT-PCR test for the qualitative detection of SA-RS-Co-V-2 based on the reverse transcriptase polymerase chain reaction (RT-PCR) method. To perform the test, CV-ID Lab requires only a 20-minute PCR run time without prior RNA extraction as part of sample preparation. After the RT-PCR, the SA-RS-Co-V-2 virus is detected on a test chip within 5 minutes and if SA-RS-Co-V-2 is present, the result can be read visually immediately. XPhyto is currently in discussions with additional POC 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 CV pandemic.
Read the full article here.
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#3. Potential XPHYF Catalyst - Pursuing Market Access In Israel
XPhyto Pursues Market Access in Israel for its CV19 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 ("CV-ID Lab") to an established medical distributor in Israel for clinical evaluation of CV-ID Lab for the purpose of commercial regulatory approval and potential product distribution.
Based on the European CE-IVD approval of CV-ID Lab, announced by the Company on March 18, 2021, CV-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 CV-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 CV-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."
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The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the CV-19 pandemic.
Read the full article here.
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#4. Potential XPHYF Catalyst - Signing Of German Distribution, Storage And Logistics Agreement
XPhyto Signs German Distribution, Storage and Logistics Agreement for 25-Minute CV19 PCR Test
VANCOUVER, BC / ACCESSWIRE / April 21, 2021 /XPhyto Therapeutics Corp. (CSE:XPHY / OTCQB:XPHYF / FSE:4XT) ("XPhyto" or the "Company") is pleased to announce that it has entered into an agreement (the "Agreement") with an established German pharmaceutical wholesaler and service provider (the "Distributor") for the distribution, storage and logistics of XPhyto's diagnostic products in Germany. The Agreement secures XPhyto a full-service distribution partner for its 25-minute SA-RS-Co-V-2 (CV-19) RT-PCR test system ("CV-ID Lab"). CV-ID Lab is registered within the European Union as a commercial in vitro diagnostic (CE-IVD) test.
Pursuant to the Agreement, the Distributor will distribute, store and deliver CV-ID Lab test kits according to the product specifications and all applicable regulations to XPhyto's customers. In addition, the Distributor will provide the documentation and fulfillment of storage obligations, the fulfillment of reporting and notification obligations, and the processing of any returned products. The obligations and services to be rendered under the Agreement satisfy all of the logistical and regulatory requirements for the commercial sale of CV-ID Lab in Germany.
"With this agreement, we have secured a strong partner with an established medical distribution network throughout Germany. This is an exciting and critical step towards commercial sales of CV-ID Lab," said Hugh Rogers, CEO and Director of XPhyto. "The Company's commercialization strategy is focused on the German market for initial product launch and the creation of robust and sustainable sales."
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The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the CV-19 pandemic.
Read the full article here.
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XPhyto Therapeutics Corp. World-class Management Team
