Agoracom Blog Home

Posts Tagged ‘Healthcare’

VIDEO: XPhyto Therapeutics $XPHY.ca $XPHYF Three Divisions Firing On All Cylinders As They Move From The Lab to the Clinic $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 4:41 PM on Tuesday, May 4th, 2021
company

Predictiv AI $PAI.ca $INOTF ThermalPass Deployed at Iredell-Statesville Schools, One of the Largest School Districts in North Carolina $PFM.ca $VQS.ca $SPOT.ca $ADK.ca

Posted by AGORACOM-JC at 8:58 AM on Wednesday, April 21st, 2021
Predictiv AI
  • Announced that it has sold and installed multiple ThermalPass temperature scanning systems in one of North Carolina’s largest school districts.
  • In accordance with the CDC’s new in-person reopening mandate, the ThermalPass touchless temperature screening system has been installed in multiple locations at Iredell-Statesville Schools in the central section of the state where more than 20,000 students attend classes across 37 campuses.

TORONTO , April 21, 2021 – Predictiv AI Inc. (TSXV: PAI) (OTC: INOTF) (FSE: 71TA) (“Predictiv AI” or the “Company”), a software and solutions-provider in the artificial intelligence markets www.predictiv.ai , is pleased to announce that it has sold and installed multiple ThermalPass temperature scanning systems in one of North Carolina’s largest school districts. In accordance with the CDC’s new in-person reopening mandate, the ThermalPass touchless temperature screening system has been installed in multiple locations at Iredell-Statesville Schools in the central section of the state where more than 20,000 students attend classes across 37 campuses.

“We were very impressed with the ease of use of the product and are thrilled to have implemented it as another layer of protection within our health and safety protocols,” said Kenny Miller , Assistant Superintendent, Facilities and Planning, Iredell-Statesville Schools. “Its accuracy and the speed of scanning, all within the normal movement of our students, allows us to dedicate resources elsewhere that would otherwise be required to operate manual temperature screening solutions. The system also allows us to remain socially distanced and to adhere to the CDC guidelines. Working with the ThermalPass team was extremely easy as they are customer-oriented and interested in providing a quality product, at a reasonable price, with superior service after the purchase. I highly recommend ThermalPass and their team if you need a simple, effective, reasonable health screening solution.”

Watch ThermalPass in action at Iredell-Statesville Schools here:
https://drive.google.com/file/d/1_2M05sDvxW-7xaNaE0gCztUHP54687Pa/view

Jason Elmaleh , President of Commersive Solutions, joint venture partner in ThermalPass said, “We’re thrilled to be working with such a dedicated group of educators who see the value in our solution now, during the pandemic and beyond, as we start to get back to our normal lives. If we are able to reduce the average number of sick days taken from students being out of school by just half a day, that will result in well over a half-million dollars of additional district funding for Iredell-Statesville Schools that would otherwise not be disbursed. We look forward to our ongoing work with them as we explore additional integrations such as adding metal detection to their units.”

“We anticipate the education market for ThermalPass will expand rapidly, especially in the US where the American Rescue Plan Act was just passed,” said Michael Lende , CEO of Predictiv AI. “This COVID-19 stimulus package includes an unprecedented US$1.9 trillion aid package to help state agencies and school districts reopen and sustain the safe operation of schools.”

While many factors contribute to school absenteeism, student illness is believed to be the main driver of student absenteeism. According to a report by EMist , the average student in the US (K-12) misses 4.5 days per school year, while the average teacher misses 5.3 days per school year. The total loss of funding to education systems associated with student absenteeism each year in the US is estimated to be $10.7 billion dollars .

For more information on Predictiv AI or ThermalPass, visit: www.predictiv.ai and follow Predictive AI on:

Facebook:https://www.facebook.com/PredictivAI/
Twitter:https://twitter.com/predictivai
LinkedIn:https://www.linkedin.com/company/predictivai/

* Predictiv AI is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 coronavirus) at this time.
* CNBC; Bidens signs $1.9 trillion covid relief package: https://www.cnbc.com/2021/03/11/biden-1point9-trillion-covid-relief-package-thursday-afternoon.html
* Emist; Absenteeism in schools: https://emist.com/absenteeism-in-schools-10-7-billion-loss-in-funding/

About Predictiv AI Inc.
Predictiv AI Inc. www.predictiv.ai is a technology company which helps businesses and organizations make smarter decisions using advanced artificial intelligence, deep machine learning and data science techniques. Its Weather Telematics Inc. subsidiary uses patented air quality monitoring sensors to provide predictive weather risk information to the insurance, logistics, fleet management and public safety sectors. The Company’s R&D division, AI Labs Inc., develops new products that solve real-world business problems. The joint venture with Commersive Solutions Corp. is developing innovative technologies for use in various public spaces, starting with the ThermalPass™ temperature screening system.

Cautionary and Forward-Looking Statements
Statements contained in this news release, which are not historical facts, are forward-looking statements that involve risk, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. All forward-looking statements included in this news release are based on information available to the Company on the date hereof. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results of the Company to differ materially from the conclusion, forecast or projection stated in such forward-looking statements. These risks, uncertainties and other factors include, but are not limited to, ThermalPass achieving the commercial results anticipated by the Company, market demand for ThermalPass and other factors referenced in the Company’s other continuous disclosure filings, which are available at sedar.com. Readers should not place undue reliance on these forward-looking statements. The Company assumes no obligation to update any forward-looking statements, except as required by applicable securities laws.

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE

XPhyto Therapeutics $XPHY.ca $XPHYF Signs German Distribution, Storage and Logistics Agreement for 25-Minute COVID-19 PCR Test $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:21 AM on Wednesday, April 21st, 2021
http://blog.agoracom.com/wp-content/uploads/2021/01/XPHYTO-70-x-70.jpg

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 SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”). Covid-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 Covid-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 COVID-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 COVID-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.”

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 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 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 COVID-19 pandemic.

About XPhyto Therapeutics Corp.

XPhyto Therapeutics Corp. is a bioscience accelerator focused on next-generation drug delivery, diagnostic, and new active pharmaceutical ingredient investment opportunities, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and standardization of emerging active pharmaceutical ingredients for neurological applications, including psychedelic compounds and cannabinoids. The Company 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.

Read More:https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/759431-xphyto-signs-german-distribution-storage-and-logistics-agreement-for-25-minute-covid-19-pcr-test/messages/2312832#message

XPhyto Therapeutics $XPHY.ca $XPHYF Adds Top-Level Executive Talent to its Global Operations $NGM.ca $SONA.ca $HBP.ca $MIR.ca $IPA.ca

Posted by AGORACOM-Eric at 8:12 AM on Tuesday, April 20th, 2021
http://blog.agoracom.com/wp-content/uploads/2021/01/XPHYTO-70-x-70.jpg
  • Mr. Wolfgang Probst appointed as the Chief Operations Officer (COO) of XPhyto
  • Addition of Mr. Manfred Buchberger as the Head of Corporate Development

XPhyto Therapeutics Corp. (CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT) (“XPhyto” or the “Company”) is pleased to announce the appointment of Mr. Wolfgang Probst as the Chief Operations Officer (COO) of XPhyto and the addition of Mr. Manfred Buchberger as the Head of Corporate Development at XP Diagnostics GmbH (“XP Diagnostics”), a wholly owned German subsidiary of the Company. With European CE-IVD approval announced March 18, 2021, for the Company’s lead diagnostic product, Covid-ID Lab, XPhyto continues to enhance its commercial team as it anticipates near-term distribution and sales.

Mr. Probst is an experienced management and finance consultant with expertise in mergers and acquisitions, corporate re-organizations, and divestitures. He has a proven track record of leadership, strategic planning, and organizational restructuring having guided multiple startups from inception to financial success. Mr. Probst was responsible for successfully structuring XPhyto’s European operations and establishing associated partnerships and collaborations, both commercial and academic. As the newly appointed COO of XPhyto, Mr. Probst will be responsible for managing the Company’s global operations. Mr. Probst will remain a director of XPhyto and the managing director of XP Diagnostics.

Mr. Buchberger is a global leader in the medical diagnostics industry. For almost a decade, he was the CEO and a member of the Global Management Board of a major European medical diagnostics and analytics company with annual revenues of over 600 million Euro. His addition to the Company brings decades of diagnostics industry experience focused on international business development, sales, marketing, and product management. Mr. Buchberger has successfully created, implemented, and managed business growth strategies across Europe, North and South America, Middle East and Asia, including the successful launch of new medical diagnostic products.

On March 18, 2021, XPhyto announced European commercial approval of Covid-ID Lab, a rapid 25-minute point-of-care PCR test for COVID-19. Mr. Probst and Mr. Buchberger will be responsible for executing the global product launch and businesses development of Covid-ID Lab.

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 portability.

Read More: https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/759347-xphyto-adds-top-level-executive-talent-to-its-global-operations/messages/2312660#message

Predictiv AI $PAI.ca $INOTF Signs F2 Factor to Provide Strategic Support Services, Bolster Sales, and Increase Distribution $PFM.ca $VQS.ca $SPOT.ca $ADK.ca

Posted by AGORACOM-AB at 9:51 AM on Tuesday, April 13th, 2021
Predictiv AI

TORONTO , April 13, 2021 /CNW/ – Predictiv AI Inc. TSXV: PAI) (OTC: INOTF) (FSE: 71TA ) (” Predictiv AI ” or the ” Company “), a software and solutions provider in the artificial intelligence markets, is pleased to announce that it has entered into a consultancy agreement, effective immediately, with F2 Factor (“F2”) to provide strategic support services to the Predictiv AI leadership team, and to increase sales and distribution across brands and products.

As a leader in multichannel marketing, sales, and distribution, F2 Factor is a firm which works in tandem with leading businesses to build and execute their sales strategy. The firm is led by Mark Collins who will be working directly with the leadership team at Predictiv AI. 

As a seasoned executive, Mark has built a track record of success, winning numerous awards throughout his career with GE and Cisco. Mark has played a leadership role in building multiple $100m franchises within global companies and worked with many start-up and scale-up companies over the years.

“Predictiv AI has already demonstrated an ability to bring cutting-edge technology to market at the right time to set the foundation for enabling intelligent infrastructure and controls for shared spaces that are game changing”, said Mark Collins, President of F2 Factor.

Read More: https://agoracom.com/ir/PredictivAI/forums/discussion/topics/758954-predictiv-ai-signs-f2-factor-to-provide-strategic-support-services-bolster-sales-and-increase-distribution/messages/2311736#message

VIDEO – Predictiv AI’s $PAI.ca $INOTF Landmark South Florida Hospital Deal for ThermalPass Scanning Devices puts AI Firm in Driving Seat $PFM.ca $VQS.ca $SPOT.ca $ADK.ca

Posted by AGORACOM-JC at 6:25 PM on Monday, April 12th, 2021
Predictiv AI

Predictiv AI’s proprietary artificial intelligence and machine learning platform provides predictive and prescriptive solutions in the public safety sector.

Its flagship product is its ThermalPass temperature scanning devices, which use cutting edge tech to mitigate the spread of contagions in public places, such as factories, supermarkets, schools, office buildings, mass-transit stations, hospitals and long-term care facilities.

  • 24 medical grade sensors
  • 1,200 readings per second
  • 1 person / second
  • Received orders for 90+ units of ThermalPass following commercial launch in October 2020

The company this month secured backing from one of the largest and most respected hospitals in the U.S., with a game-changing deal to install multiple ThermalPass temperature scanning devices in Memorial Healthcare System’s flagship South Florida hospital and its six-hospital network.

$PAI has also been making strides with its subsidy Weather Telematics, which:

  • Launched its Alert Fleet product, a road weather hazard alert system for commercial fleets.
  • Alert Fleet advises drivers of dangerous conditions, such as black ice or hydroplaning, 200 metres ahead, thus providing time to mitigate risk and avoid accidents
  • Recent partnership with Propel IT to accelerate commercialization of IT SAAS Fleet Safety Platform

The latter partnership will significantly enhance available real-time data access for drivers and dispatchers.   

Michael Lende, Predictiv AI’s CEO and President, breaks down the news:

Predictiv AI’s $PAI.ca $INOTF ThermalPass Adopted by Memorial Healthcare System $PFM.ca $VQS.ca $SPOT.ca $ADK.ca

Posted by AGORACOM-AB at 9:45 AM on Friday, April 9th, 2021
Predictiv AI

TORONTO , April 9, 2021 – Predictiv AI Inc. TSXV: PAI) (OTC: INOTF) (FSE: 71TA ) (” Predictiv AI ” or the ” Company “), www.predictiv.ai , a software and solutions provider in the artificial intelligence markets, is pleased to announce it has installed multiple ThermalPass temperature scanning devices in Memorial Healthcare System hospital facilities in south Broward County.

Memorial is a leader in providing high-quality healthcare services to South Florida residents through its six-hospital network and various ancillaries throughout South Florida.  The initial rollout of units was completed at Memorial Regional Hospital, the flagship facility and one of the largest hospitals in the state and Memorial Regional Hospital South, home of the Rehabilitation Institute.

“With COVID-19 still threatening our community, it’s important for us to continue using technology in a way that will help us maximize our team’s time and provide quality and safe care to our community,” said Dawn de la Vega , MSN, RN, Director of Nursing at Memorial Regional Hospital.  “We have integrated ThermalPass, which has helped us eliminate forehead temperature checks and capture core temperature for employees reporting to work in a more efficient manner.”

“It is an honour to be of service to one of America’s top healthcare systems, having garnered many prestigious awards over the years, including having been selected by the American Hospital Association from more than 5,000 hospitals as the national model for improving the health of the community,” said Jason Elmaleh, President of Commersive Solutions, joint venture partner in ThermalPass.

Read More: https://agoracom.com/ir/PredictivAI/forums/discussion/topics/758783-predictiv-ai-s-thermalpass-adopted-by-memorial-healthcare-system/messages/2311375#message

Predictiv AI’s $PAI.ca $INOTF Weather Telematics Partners with Propel IT to Accelerate Commercialization of IT SaaS Fleet Safety Platform $PFM.ca $VQS.ca $SPOT.ca $ADK.ca

Posted by AGORACOM-AB at 9:45 AM on Tuesday, March 23rd, 2021
Predictiv AI

TORONTO , March 23, 2021 /PRNewswire/ – Predictiv AI Inc. (TSXV: PAI) (OTC: INOTF) (FSE: 71TA) (” Predictiv AI ” or the ” Company “), www.predictiv.ai , a software and solutions provider in the artificial intelligence markets is pleased to announce that its wholly-owned subsidiary, Weather Telematics Inc. (” WTX “), has formalized a strategic product integration partnership with Propel IT Inc. (” Propel “).

The new partnership will significantly enhance available real-time data to which drivers and dispatchers can access. WTX’s hyperlocal, advanced road weather hazard alert system warns drivers of impending dangerous conditions such as black ice, poor visibility and hydroplaning.

Propel is a technology and data company that maximizes safety and efficiency in commercial fleets, who have been serving the transportation and logistics industry in the United States for more than 9 years. Propel is focused on improving driver safety, lowering insurance costs, and reducing environmental impact through fuel savings. Once commercially deployed and integrated, the Alert Fleet system will run as a SAAS model with a monthly recurring revenue component proportionate to the number of vehicles within a customer’s fleet.

“Smarter driving to us means preventing and reducing the impact of accidents for drivers and others on the road. By integrating Alert Fleet with our existing software offerings, our users will now have access to unparalleled real-time advanced hazardous road condition alerts which greatly enhances our efforts to save lives and minimize accidents that could otherwise have been preventable,” said Michael Dieschbourg, President of Propel IT.”

Read More: https://agoracom.com/ir/PredictivAI/forums/discussion/topics/757865-predictiv-ai-s-weather-telematics-partners-with-propel-it-to-accelerate-commercialization-of-it-saas-fleet-safety-platform/messages/2309368#message

Waterloo.AI and AMC: #AI Industry Day – Webinar Event on March 25, 2021 | 8:30 am to 4:00 pm – Predictiv AI $PAI.ca $INOTF $PFM.ca $VQS.ca $SPOT.ca $ADK.ca

Posted by AGORACOM-JC at 6:57 PM on Saturday, March 20th, 2021
http://blog.agoracom.com/wp-content/uploads/2021/02/PAI-Square1.jpg

Earlier this week, Predictiv AI announced a new partnership with the Waterloo Artificial Intelligence Institute at the University of Waterloo. The collaboration will allow Predictiv AI’s subsidiary, AI Labs Inc., access to the world’s top artificial intelligence resources, creating much greater bandwidth in ideation, research, and development of solutions for real-world problems.

“We are very excited and honoured to be working with one of the world’s leading artificial intelligence institutions. We will now be able to accelerate our innovations and scale our team’s productivity while learning new ways to approach projects with new and unique technologies,” said Michael Lende, CEO of Predictiv AI. “The formalization of this relationship is a crucial building block in our growth plans as it allows us to remain asset-light while simultaneously accelerating innovation on our artificial intelligence and deep machine learning-based solutions. We look forward to a long-term association with Waterloo.AI.”

As part of our ongoing efforts to support Waterloo.AI and its partners, we’re very pleased to share information about an event they will be hosting next week – AI Industry Day on Tuesday, March 25th

The event will be hosted via Microsoft Teams and will be an interactive and informative online event, enabling Industry to get more acquainted with various AI success stories across multi-sectors of the economy. Catering to diverse interests, attendees will have the option to choose from a menu of topics, with one stream focusing on the use of AI within Advanced Manufacturing. Applicable to all sectors, the keynote speaker will deliver the first-hand experience of “The Journey to Implement AI”, and the importance of “Data” in the future of AI. Morning and afternoon presentations are planned around a mid- day networking event amongst attendees, partners, researchers, and the Waterloo AI Eco-System.

Please feel free to check out the agenda below, click the previous link to discover more information about the event and/or additional details about each presentation, and lastly, make sure to register for the event

– it’s completely free and promises to be fun & informative!

Click image to enlarge.

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
This image has an empty alt attribute; its file name is XPHYTO-70-x-70.jpg
  • 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.

Read More:https://agoracom.com/ir/XphytoTherapeutics/forums/discussion/topics/757566-xphyto-announces-european-approval-for-25-minute-covid-19-pcr-test/messages/2308737#message