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XPhyto Therapeutics $XPHY.ca $XPHYF Announces European Approval for 25 Minute COVID-19 PCR Test $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:35 AM on Thursday, March 18th, 2021
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  • CE Mark received for in vitro diagnostic (IVD) test for the detection of SARS-CoV-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

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 SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”). Covid-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 COVID-19 tests currently approved. With a sample collection to result time of 25 minutes, Covid-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. “Covid-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.”

Covid-ID Lab is a multiplex viral RNA probe kit based on the reverse transcriptase-polymerase chain reaction (RT-PCR) method. For assay performance, Covid-ID Lab requires only a single 20-minute PCR thermal cycle 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 the risk of cross-contamination 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 portability.

During validation of the assay, the limit of detection for SARS-CoV-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.

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XPhyto Therapeutics Partner $XPHY.ca $XPHYF Receives ISO Certification for 25-Minute COVID-19 RT-PCR Test $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 10:10 AM on Wednesday, March 10th, 2021
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  • Launching of Covid-ID Lab, A Rapid, Accurate & Robust COVID-19 Test System
  • Licensing & Distribution Partnerships Coming

XPhyto Therapeutics Corp. (CSE:XPHY / OTCQB:XPHYF / FSE:4XT) (“XPhyto” or the “Company”), and its exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”), are pleased to announce successful EN ISO 13485 certification for the rapid point-of-care, SARS-CoV-2 RT-PCR Test System (“Covid-ID Lab”). This standardization and quality assurance certification provides authorization for distribution of Covid-ID Lab upon receipt of CE mark (CE-IVD) approval. The Company expects CE-IVD approval as an in vitro diagnostic product in March 2021.

EN ISO 13485 is the internationally recognized European standard for quality control and management systems in the design and manufacture of medical devices. It is accepted as the basis for CE certification of medical devices under relevant European directives and regulations.

“We are pleased to remain on schedule with the launch of Covid-ID Lab and will continue to move forward as efficiently as ever,” said Hugh Rogers, CEO and director of XPhyto. “At the same time, our experienced launch team is working hard to bring Covid-ID Lab to market and to establish German and international licensing and distribution partnerships.”

Covid-ID Lab was designed to be a rapid, accurate and robust COVID-19 test system with reduced operating costs and increased convenience and portability. As previously announced on February 24, 2021, the company placed its first production order from 3a for 9,600 individual tests. Delivery of this first order is expected by mid-March 2021 and is primarily intended to provide potential German and international distributors and licensees and their respective government regulators with test samples for review and evaluation. Initial commercial manufacturing is planned for Germany, with additional capacity in other jurisdictions expected to follow. The sales launch in Europe is targeted for April 2021. XPhyto is currently in discussions with potential distribution and wholesale partners in Europe and the Middle East.

XPhyto and 3a are also developing a portfolio of oral biosensor screening tests for detection of bacterial and viral infectious diseases, including influenza A, group A strep, stomatitis, periimplantitis, and periodontitis. Additional pandemic-focused biosensors are in development, specifically for H1N1 (swine flu), and H5N1 (avian flu). The Company is planning the commercial launch of its first biosensor product in the second half of 2021.

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XPhyto Therapeutics $XPHY.ca $XPHYF Completes Corporate Rebranding and Launches New Website $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:05 AM on Thursday, March 4th, 2021
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  • Rebranding Reflects XPhyto’s Commitment To Operational Achievement
  • Product Development Advance From The Lab To The Clinic
  • Cusp Of Two Major Commercial Milestones Related To Our Rapid Point-Of-Care COVID-19 PCR Test System
  • A Bioscience Accelerator At The Leading-Edge Of The Life Science Industry

XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”), is pleased to announce that the Company has completed a corporate rebranding and launched a new website which can be viewed at www.xphyto.com.

The rebranding decision reflects the Company’s commitment to operational achievement in 2021 as a number of product development programs advance from the laboratory to the clinic. As a bioscience accelerator at the leading-edge of the life science industry, XPhyto is targeting value creation through commercialization of its development pipeline and focused investment in impact driven innovation.

“The Company is excited to introduce a fresh look at such a pivotal point in our business growth,” said Hugh Rogers, CEO & Director of XPhyto. “With all technical requirements fulfilled, we are on the cusp of two major commercial milestones related to our rapid point-of-care COVID-19 PCR test system. With expected ISO certification and CE-IVD approval pending, we are excited to enter the next phase of our business with a positive, crisp and energetic new image.”

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. Further, its COVID-19 related test products are not yet approved and are still subject to risks associated with the regulatory approval process.

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XPhyto Therapeutics $XPHY.ca $XPHYF Places First Order for 25-Minute Covid-19 RT-PCR Tests $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:05 AM on Wednesday, February 24th, 2021
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  • Placed First Order for its Rapid Point-Of-Care COVID-19 Test System
  • 9600 Individual Tests Ordered
  • Mid-March Delivery
  • Additional Pandemic-Focused Biosensors in Development

XPhyto Therapeutics. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company“), is pleased to announce that it has placed the first order for its rapid point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”) from its exclusive diagnostic development partner, 3a-diagnostics GmbH (“3a”).

The first order of Covid-ID Lab is for 9,600 individual tests, which are packaged in 200 kits of 48 tests each. Delivery of the first order is expected by mid-March 2021 and will be primarily used to supply prospective distribution partners and licensees and their respective government regulators with test samples for review and evaluation. The tests will be manufactured in the German state of Baden-Württemberg.

“We are pleased to report that all steps towards the launch of Covid-ID Lab remain on track within an ambitious timeline,” said Hugh Rogers, CEO, and Director of XPhyto. “Our experienced market launch team is working quickly to bring the product to market, as well as to establish licensing and distribution partnerships. We are confident that Covid-ID Lab, as a 25-minute PCR test with minimal technical and personnel requirements, will be a stand-out product in the COVID-19 test market.”

Covid-ID Lab was designed to be a rapid, accurate, and robust COVID-19 test system with reduced operating costs and increased convenience and portability. XPhyto expects 3a to receive ISO 13485 medical device manufacturer approval by the end of February and European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) for Covid-ID Lab by early March. Initial commercial manufacturing is planned for Germany, with additional capacity in other jurisdictions to follow. The sales launch in Europe is targeted for April 2021. XPhyto is currently in discussions with potential distribution and wholesale partners in Europe and the Middle East.

XPhyto and 3a are also developing a portfolio of oral biosensor screening tests for detection of bacterial and viral infectious diseases, including influenza A, group A strep, stomatitis, periimplantitis, and periodontitis. Additional pandemic-focused biosensors are in development, specifically for H1N1 (swine flu) and H5N1 (avian flu). The Company is planning the commercial launch of its first biosensor product in the second half of 2021.

Read More: https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/755962-xphyto-places-first-order-for-25-minute-covid-19-rt-pcr-tests/messages/2305102#message

XPhyto Therapeutics $XPHY.ca $XPHYF Builds Commercial Team to Launch 25-Minute Covid-19 Test $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:32 AM on Monday, February 22nd, 2021
  • Expedited formation of commercial team to launch its point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system
  • Expects medical device manufacturer approval by the end of February
  • European regulatory approval as a commercial in vitro diagnostic device by early March.

XPhyto Therapeutics Corp. (CSE:XPHY / OTCQB:XPHYF / FSE:4XT) (“XPhyto” or the “Company“), is pleased to announce that the Company has expedited the formation of an experienced commercial team to launch its point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”). Covid-ID Lab was developed by XPhyto’s exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”). XPhyto expects 3a to receive ISO 13485 medical device manufacturer approval by the end of February and European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) for Covid-ID Lab by early March.

The market launch team consists of world-class clinical and pharmaceutical executives and service providers who bring the experience and expertise necessary to effectively and rapidly drive the commercialization of Covid-ID Lab. Collectively, the team brings decades of experience in the biotech and pharmaceutical industries, including: executive leadership, business development, regulatory compliance, product launch, international marketing and sales, production, quality assurance, and M&A. In particular, members of the team have led medical diagnostic company growth from inception to over 500 million Euro per year in multinational sales.

“We are extremely fortunate to now have a team with deep expertise in medical diagnostic product commercialization. The team has extensive experience from regulatory approval to international production and sales,” said Hugh Rogers, CEO and Director of XPhyto. “As we near expected regulatory approval, XPhyto’s business is rapidly evolving from innovation to impact. We are working hard to put the Company in the best possible position to execute on our business strategy.”

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Xphyto $XPHY.ca $XPHYF European CE-IVD Application for 25-Minute COVID-19 RT-PCR Test $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:11 AM on Tuesday, February 16th, 2021
  • Expects approval as a medical device manufacturer by late February
  • European regulatory approval as a commercial in vitro diagnostic device by early March.
  • Covid-ID Lab was designed to be a rapid, accurate and robust test system with reduced operating costs and increased convenience and portability.

XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”), and its exclusive German diagnostics development partner, 3a-diagnostics GmbH (“3a”), are pleased to announce all actions and procedures required for XPhyto Therapeutics Corp.’s European regulatory application for the rapid point-of-care SARS-CoV-2 (COVID-19) RT-PCR test system have been completed. 3a-diagnostics GmbH, Xphyto’s exclusive German diagnostics development partner, expects ISO 13485 approval as a medical device manufacturer by late February and European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) for Covid-ID Lab by early March.

“We are very pleased with the team’s swift development progress,” said Hugh Rogers, CEO & Director of XPhyto. “Our goal was to create the fastest and most portable COVID-19 PCR test on the market. We are confident in our prospects for an expedited approval and look forward to commercial launch in short order”

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VIDEO – AGORACOM Beyond The Expert Welcomes Venture Capitalist Leigh Hughes To Discuss Mountain Valley MD $MVMD, Valeo Pharma $VPH $VPHIF and Xphyto Therapeutics $XPHY $XPHYF

Posted by AGORACOM-JC at 6:36 PM on Thursday, February 11th, 2021

AGORACOM followers have given us great feedback on our hit series “Beyond The Press Release” (BTPR) in which we speak with small cap CEO’s about important press releases in greater depth and, quite frankly, in layman’s terms for investors to truly understand their significance.  

Nowhere is this more important than in the world of disruptive technologies, biotech and pharma.  Each of these industries share two distinct traits:

  • The possibility for explosive growth with disruptive new products
  • Difficulty in conveying disruptive new products that, by their nature, have never been seen before by investors.

Whereas BTPR tells these stories from the side of small cap public companies, Beyond The Expert (BTE) tells these stories from the perspective of experts on these topics – and we couldn’t think of anyone better to start off this series than Leigh Hughes.  

Leigh is a Venture Capitalist who I’ve personally watched conduct incredible due diligence and invest into many small cap companies that have generated incredible returns over 12-18 month periods.    

Leigh is so good at what he does that many global private equity funds and institutions take his call and often follow him into investments he chooses to make.  Moreover, he serves as an advisor to several small cap companies.

If you ever wanted to truly learn how to become a great small cap investor, it doesn’t get much better than this.  

Without further adieu, watch this great interview with Leigh Hughes and make sure to provide us with your feedback via comments on Twitter, YouTube or wherever you may be watching or listening.

Xphyto $XPHY.ca $XPYHF to Produce Mescaline for Psychedelic Programs $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:21 AM on Wednesday, February 10th, 2021
  • Focused on the synthesis of pharmaceutical grade mescaline
  • Mescaline has shown particular promise for the treatment of addiction and depression.

Xphyto Laboratories Inc., Xphyto Therapeutics Corp.’s wholly owned Alberta subsidiary, has added mescaline production to its psychedelic medicine programs. Further to the Company’s press release dated February 3, 2021, the capacity under contract with Applied Pharmaceutical Innovation will focus on the synthesis of pharmaceutical grade mescaline. Mescaline has been anecdotally recognized as a relatively safe psychedelic drug and has shown particular promise for the treatment of addiction and depression.

“In addition to our European-based psilocybin biotechnology production, the Company has now expanded its portfolio of psychedelic compounds to include mescaline. Our goal is to develop industrial scale production processes for the wholesale market and for incorporation into XPhyto’s thin film drug delivery platforms” commented Hugh Rogers, CEO & Director. “We see a significant market opportunity in the production of pharmaceutical mescaline and the standardization of dosage formulations with precise, predictable and efficient drug delivery for clinical study and therapeutic use”

Mescaline (3,4,5-trimethoxyphenethylamine) is a naturally occurring psychedelic compound found in certain cacti, including peyote, San Pedro, and Peruvian torch, and is most commonly associated with traditional Native American religious rituals and ceremonies. Mescaline is a Schedule I drug in the United States; however, it is legal in certain religious ceremonies registered by the Native American Church and its use is expanding as a supplement to various types of meditation and psychedelic therapy.

In general, psychedelic compounds have emerged as a new class of drugs with the potential to improve the treatment of mental health related medical conditions such as depression, anxiety, addiction, and trauma-related stress disorder. The Company believes that the industrial-scale production of pharmaceutical grade psilocybin and mescaline will provide a strong foundation for its psychedelic medicine programs.

Read More:https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/755075-xphyto-to-produce-mescaline-for-psychedelic-programs/messages/2303018#message

Xphyto Unit $XPHY.ca $XPYHF Signs Psychedelic Deal with Applied Pharma $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:29 AM on Wednesday, February 3rd, 2021
  • Announces Psychedelic Pharmaceutical Production Agreement
  • Synthesis of pharmaceutical grade psychedelic compounds
  • Working toward regulatory approval for the commercial production process

XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”) is pleased to announce that XPhyto Laboratories Inc. (“XPhyto Labs”), its wholly owned Alberta subsidiary, has signed an agreement (the “Agreement”) with Applied Pharmaceutical Innovation (“Applied”) for the synthesis of pharmaceutical grade psychedelic compounds and the parallel development of the standard operating procedures necessary to obtain regulatory approval for the respective commercial production process.

The industrial-scale production of standardized active pharmaceutical ingredients is an important part of XPhyto’s psychedelic pharmaceutical program as the Company anticipates a shortage of large-scale supply of certain approved and standardized pharmaceutical grade psychedelics.

Applied is a not-for-profit institution at the University of Alberta created to support translational drug development for industry and innovators. With an interdisciplinary team of over 30 pharmaceutical scientists, clinicians, regulatory, patent, and market experts, Applied provides industry with access to translational science in a framework that supports commercial success. This includes retention of IP and ownership of work product for the funder, focused and efficient project execution, and regulatory compliant operations.

Read More: https://agoracom.com/ir/XphytoTherapeutics

XPhyto Therapeutics $XPHY.ca $XPYHF Announces Drug Formulation Strategy and 2021 Milestones Innovation to Impact $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 7:56 AM on Thursday, January 28th, 2021
  • Construction of commercial drug manufacturing facility in Germany
  • Four clinical studies in neurological indications in 2021
  • Development of oral biosensor and contract development & manufacturing
  • Psychedelic transdermal and sublingual drug formulation development

VANCOUVER, BC / ACCESSWIRE / January 28, 2021 / XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company“) is pleased to announce its drug formulation and delivery business strategy and milestones for 2021. As a bioscience accelerator at the leading-edge of the life science industry, XPhyto targets growth through commercialization of its product pipeline and focused investment in impact driven innovation with the potential for meaningful value creation.

Further to XPhyto’s press release dated January 18, 2021, the Company’s core milestones for this year include the commercialization of infectious disease diagnostics, the clinical validation of transdermal and sublingual drug formulations and continued investment in psychedelic medicine.

Regarding XPhyto’s drug formulation business, the Company is pleased to set out the strategy and milestones for 2021 of its wholly owned German subsidiary, Vektor Pharma TF GmbH (“Vektor”). Vektor will position itself for commercial manufacturing, pipeline development and drug formulations for critical mental health conditions.

“2021 is expected to be a transformative year for Vektor. We will be building on significant momentum from 2020 as we advance our drug formulation, contract development, and psychedelic business,” said Prof. Dr. Thomas Beckert, managing director of Vektor Pharma TF GmbH. “The addition of scalable in-house manufacturing capability creates the potential for significant growth across virtually all of our development and commercialization programs.”

Vektor is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of thin film drug formulations, particularly transdermal patches and sub-lingual (oral) strips for the delivery of active pharmaceutical ingredients (“API”) for the treatment of pain and neurological conditions.

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