sabay
3 years ago
FluroTest Provides System Development Update
FluroTest Provides System Development Update; Announces Further Progress Optimizing the Immunoassay for SARS-CoV-2 Detection
CALGARY, Alberta, Dec. 07, 2021 (GLOBE NEWSWIRE) -- FluroTech LTD. (TSXV: TEST) (OTCQB: FLURF) and wholly owned subsidiary FluroTest Diagnostic Systems ("FluroTest" or The Company), a developer of diagnostics technology in high output rapid antigen testing for the detection of SARS-CoV-2 and other pathogens, today provided a progress update on its efforts to bring its Pandemic Response Platform to market.
About FluroTest Diagnostic Systems Ltd.
FluroTest, a diagnostics technology leader in surge-scale rapid antigen testing for the detection of SARS-CoV2 and other pathogens, is developing a pandemic defense and economic recovery system purpose-built for businesses and special-needs populations requiring fast and highly accurate testing for a high number of people. Unlike individual or low-throughput tests, FluroTest's system is designed to be well-suited for high-traffic, high-risk pandemic environments including schools and colleges, hospitals and large healthcare facilities, athletic stadiums and performance venues, airline and cruise ship terminals, corporate campuses, shopping centers, manufacturing facilities, transportation and distribution hubs and other large business and retail locations. Created to support business continuity efforts and public well-being, the system combines and leverages the disciplines of robotics automation, biochemistry, fluorescence detection and cloud computing – with the concept processing thousands of tests per hour while delivering accurate, digitally verifiable results to a test taker's mobile device within 10 minutes.
FluroTest has been developing its “Pandemic and Emerging Disease Defense Platform” since late January 2021. The Company has made significant progress in its research and development efforts during just this 10-month period. Through continued optimization over the last few weeks, the Company has achieved what it believes is a breakthrough with it efforts to optimize its testing protocol and is realizing a 50x to 60x improvement in all aspects of the process, as compared to the 30x to 40x it previously reported on November 19, 2021. Based on these improvements to date, the Company’s test is performing at a level consistent with approximately 48% of current FDA approved antigen tests in the market which average at least about 15 minutes per test and more complicated to administer to a number of people at once. These improved results have occurred because of the changes made to its testing protocol. Management believes that, with the new protocol, it will be able to further improve these results with additional refinement.
The Company has recruited key advisors, as per the announcement on June 10, 2021, with deep experience in both specific technologies being deployed and commercialization of other diagnostic assays unrelated to COVID. The Company believes that its technology will represent a disruptive breakthrough in the development of its high volume, high speed “point of entry/point of access” testing solution.
Important breakthroughs include:
Fewer steps in sample processing – The simplified sample processing protocol has eliminated 43% of the sample processing steps, thus reducing time and complexity.
Testing protocol simplification – As a result of the simplification of the testing protocol, the Company has made great strides in refining the type of instrumentation required to read processed test samples, further reducing the time necessary for each reading as well as reducing the capital cost of field-based instrumentation hardware by as much as 50% as well as reducing the equipment footprint by 40%. Both of these improvements make the system accessible to many more “point of entry” environments, such as airports, schools, university campuses, hospital entrances, to name a few.
Materials cost per test reduced – While initial estimates of the direct cost of each test to the Company would approximate US $5.00 to US $6.00, the Company’s optimized protocol development efforts are aimed at producing a direct cost per test of approximately $1.00, thus providing the Company with flexibility in pricing tests much lower to the consumer while still maintaining favorable gross profit margins. It is hoped that this costing will lend itself to mass testing at an affordable cost and in return should assist in helping to reduce super spreader events.
Platform solution cost per test improved – The optimization of sample processing and equipment necessary to process tests will lower the capital cost per platform by as much as 50%, thus making the platform solution more affordable to more potential customers and enabling more frequent testing.
“The process for scientific discoveries and innovation takes rigorous work. However, through our scientific process, the Company has achieved breakthrough improvements this year. With the adaptation of the Pandemic Defense system to utilize a new immunoassay technology the development team is gaining momentum in finalizing assay development for clinical trials. We will have created a system that can serve a significantly greater population in even more environments than we originally anticipated and at a much lower cost, there is still much to do, but we are optimistic as to the outcome,” said Bill Phelan, CEO of FluroTest.
The Company expects in 3 to 4 months it will complete test optimization, protocol development, and prepare to enter clinical trials.
Readers are cautioned that, although FluroTest has achieved proof of concept prototype, the testing method and device is still in the pre-approval stage and accordingly FluroTest is not currently making any express or implied claims that the technology can, or will be able to, accurately detect the COVID-19 virus.
About FluroTech (TSXV: TEST) (OTCQB: FLURF)
The goal of FluroTech's research and technology is to develop detection methods which are high speed, sensitive, specific and easy-to-use. By combining FluroTech's proprietary spectroscopy-based technology with laboratory robotics automation and cloud computing, FluroTech, through the application of its technology and investment in FluroTest Diagnostics Systems Ltd. ("FluroTest"), the interests in which have been disclosed in previous press releases, has created a unique solution addressing the current and future pandemics. Based upon technology that was first developed at the University of Calgary, the FluroTest SARS-CoV-2 test is designed to identify patients with active virus infection; this is not necessarily the case for most of the currently approved tests that are meant to identify patients with SARS-CoV-2 nucleic acid.
To learn more, visit FluroTest.com.
For general FluroTech inquiries:
FluroTech Ltd.
Danny Dalla-Longa, CEO
info@FluroTest.com
sabay
3 years ago
FluroTest Provides System Development Update
FluroTest Provides System Development Update; Reports Point of Access Test System and Immunoassay for SARS-CoV-2 Detection is Fully Functional
CALGARY, Alberta, Nov. 19, 2021 (GLOBE NEWSWIRE) -- FluroTech LTD. (TSXV: TEST) (OTCQB: FLURF) and wholly owned subsidiary FluroTest Diagnostic Systems ("FluroTest" or The Company), a developer of diagnostics technology in high output rapid antigen testing for the detection of SARS-CoV-2 and other pathogens, today provided a progress update on its efforts to bring its Pandemic Response Platform to market.
FluroTest has been developing its “Pandemic and Emerging Disease Defense Platform” since late January 2021. The Company has made significant progress in its research and development efforts during just this 10-month period. The Company has optimized its test protocol and is realizing a 30x to 40x improvement in all aspects of the process. The Company has recruited key advisors with deep experience in both specific technologies being deployed and commercialization of other diagnostic assays unrelated to COVID. Based on the results from the new protocol, the Company believes it is positioned to achieve a disruptive breakthrough in the development of its “point of entry /point of access” testing solution.
Important breakthroughs include:
Reduction of steps in sample processing – This resulted in an optimized sample processing protocol reducing time and complexity as well as the elimination of certain laboratory processing equipment in the testing system solution.
Testing protocol simplification – The Company has made great strides in refining the type of instrumentation required to read processed test samples, further reducing the time necessary for each reading as well as reducing the capital cost of field-based instrumentation hardware by as much as 50%.
Materials cost per test reduced – While initial estimates of the direct cost of each test to the Company would approximate US $5.00 to US $6.00, the Company’s optimized protocol development efforts produced a cost estimate per test of less than $1.00, thus providing the Company with significant flexibility in pricing tests much lower to the consumer while still maintaining favorable gross profit margins.
Platform solution cost per test improved – The optimization of sample processing and equipment necessary to process tests will lower the capital cost per platform by as much as 50%, thus making the platform solution more affordable to significantly more potential customers and enabling more frequent testing.
The Company expects in 3 to 4 months it will complete test optimization, protocol development, and prepare to enter clinical trials.
“The process for scientific discoveries and innovation takes rigorous work. However, through our rigorous scientific process the Company has achieved breakthrough improvements this year. We will have created a system that can serve a significantly greater population in even more environments than we originally anticipated and at lower cost,” said Bill Phelan, CEO of FluroTest.
“FluroTest is on the way to achieving significant breakthroughs in the areas of testing and surveillance support for emerging diseases and pandemic mitigation. By dramatically reducing its cost per test as well as the initial investment in the test platform, it can be accessible to more populations on a low cost basis globally,” said Dr. Joxel Garcia, the 14th US Assistant Secretary for Health and former US Representative to the W.H.O., and scientific advisor to FluroTest.
Readers are cautioned that, although FluroTest has achieved proof of concept prototype, the testing method and device is still in the pre-approval stage and accordingly FluroTest is not currently making any express or implied claims that the technology can, or will be able to, accurately detect the COVID-19 virus.
sabay
3 years ago
...however...on site rapid testing is a future necessity
I personally don't see how home tests can be accepted outside the home. For example, to board a flight a friend or family member can be tested, and that result used... so I think on site rapid testing will be a future necessity.
It's hard to know what to believe, but apparently in countries where vaccination rates are highest, Covid rates are increasing among the vaccinated (Israel, Iceland, Singapore, Canada, U.S.). If vaccinations work, why are boosters needed? And if one is considered unvaccinated until a month after a shot, or considered unvaccinated a few months later, we might be seeing the beginning of the end for these experimental treatments.
If people who are vaccinated can still transmit or receive the virus, I think on site rapid testing will be a future necessity.
There is so much conflicting information out there it's hard to know what to believe. I think some potential locations for testing are no longer in play, like sports & entertainment arenas.
But I do think there are are locations where on site rapid testing will be a future necessity, like airports and other international transit points, and university campuses.
If FluroTest is accurate and quick and inexpensive, I believe the market is huge.... if they complete testing soon!
sabay
3 years ago
..maybe a game changer..
White House Plans To Quadruple COVID Rapid Testing Despite Decline In Cases
As more rapid at-home COVID tests are approved by American regulators, the Biden Administration is reportedly preparing another "investment" in rapid at-home tests (despite lingering criticisms about the frequency of false positives produced by these tests, helping to contribute to America's COVID "casedemic").
According to Bloomberg, the Biden Administration is preparing to announce a $1 billion purchase of rapid at-home COVID tests with the intention of "expanding the availability of such products in the coming months".
Of course, as we have reported time and time again, the more testing, the more cases. With this latest investment (which has yet to be officially announced) the US will be on track to 4x rapid testing capacity by December. The plan will involve distributing the free tests to an additional 10K US pharmacies, bringing the total number of free testing sites to 30K (including 20K pharmacies).
So far, rapid at-home testing has proven less reliable than lab testing. Despite this, the Biden Administration is still planning to pour billions of dollars into its effort to quadruple the level of COVID testing by December, according to BBG. According to an administration official who spoke with BBG, the US has been producing roughly 30MM rapid at-home tests a month - a figure that's expected to grow to more than 200MM a month by the end of the year.
The Administration is justifying the decision to increase testing with the fact that not enough American adults have been vaccinated (even though scientists now believe "herd immunity" is essentially out of reach for humanity, even if 90%+ of the population has been fully vaccinated).
Furthermore, this latest $1 billion commitment comes on the heels of a $2 billion investment in rapid testing announced by the administration last month (that order included buying tests from pharma giants Abbott Labs and Celltrion). Biden is also using the Defense Production Act to help bolster production.
The FDA just cleared a rapid at-home test from Acon Labs. The agency says that test could double rapid at-home testing capacity in the weeks ahead as the company says it can produce more than 100MM tests a month by year's end. Other manufacturers of rapid at-home tests include Abbott, Quidel Corp, Becton DIckinson, Access Bio and OraSure.
With cases finally declining in the US, authorities this week have praised Merck's new "miracle drug" that purports to successfully treat COVID if taken within 5 days of infection for both vaccinated and unvaccinated cases (if a patient can afford it).
But all of this isn't enough for the Biden Administration. Case numbers are falling, yet the White House continues to try and coerce unvaccinated Americans to accept the jab.
Bottom line: if you're excited to see COVID cases declining, just wait a few weeks until the White House can ramp up testing again and revive the "casedemic", triggering a new wave of media scaremongering, even if hospitalizations and deaths continue to wane.
sabay
3 years ago
FluroTest Provides System Development Update
Reports Saliva-based Point of Access Test System and Immunoassay for SARS-CoV-2 Detection is Fully Functional
CALGARY, Alberta, Sept. 16, 2021 (GLOBE NEWSWIRE) -- FluroTech LTD. (TSXV: TEST) (OTCQB: FLURF) and wholly owned subsidiary FluroTest Diagnostic Systems ("FluroTest" or The Company), a diagnostics technology leader in high output rapid antigen testing for the detection of SARS-CoV-2 and other pathogens, today provided a progress update on efforts to bring its Pandemic Response Platform to market.
Notable product developments include:
Platform Development: FluroTest’s entire “end-to-end” Pandemic Response Platform is fully operational. This includes saliva collection kits, viral deactivation agents, the robotics automation test processing platform, the software operating the robotics automation platform, the immunoassay required to process saliva samples, and the microplate reader necessary to assess the presence of SARS CoV-2 from processed samples. The system is successfully obtaining readings for the presence of the virus. Three test processing platforms are fully functional and operating at NanoComposix, our immunoassay development partner; Toolbox, our clinical trials partner; as well as in the FluroTest Laboratories in Calgary. The system is processing 96 tests per batch at a time.
Platform Optimization Commencing: The Company is transitioning from platform development to commercial product optimization focused on accuracy of the test as well as throughput of the platform to prepare for the pre-clinical trial stage as well full clinical trials. The team is currently focusing on answering three questions. First, the level of effort required to optimize each step in the highly automated process. Second, the time required to complete each optimization step. Third, the capital required to accomplish this, along with successfully completing pre-clinical trials, clinical trials, and EUA submission to the FDA. This effort is being led by the management team as well as key advisors who are also significant shareholders in the Company.
Notable market developments include:
Vaccination / Weekly Testing Mandate: The Company has been closely reviewing the Biden administration’s new directive from the US Labor Department requiring all businesses with 100 or more employees to ensure their workers are either vaccinated or tested once a week. This policy is estimated to impact close to two-thirds of the American workforce, and businesses found not to be in compliance could face thousands of dollars in fines per employee.
Delta’s Impact and the Emergence of Other Variants: “I remain in regular contact with colleagues at the World Health Organization and other global public health agencies, discussing global seroprevalence levels as well as the impact and evolution of new variants driving mass transmission surges,” said Dr. Joxel Garcia, FluroTest Chief Medical Officer and Former US Assistant Health Secretary. “People who have been infected with or vaccinated against SARS-CoV-2 appear to have reduced risk of serious subsequent infection, but vaccine resistance combined with emerging variants have placed us in an unwinnable race to herd immunity. The concept is an optimistic but hollow soundbite. Science tells us we need to prepare for the long haul.”
Cases Remain High: The Associated Press reports that US cases have climbed back to levels not seen since last winter and CNN is reporting US hospitals are fighting against a sharp upward trend in cases and deaths.
“Elongated development timelines have been frustrating for everyone, but the team’s resolve to deliver a platform that will facilitate widespread point of access and surge-scale SARS-CoV-2 testing is unwavering,” said Bill Phelan, CEO of FluroTest. “The system is working and detecting the virus. Our approach is novel and the global need remains strong as it is now clear to the world that testing will be necessary for our lifetimes. As we continue to develop our end to end solution, it has been notable for us to find that there is no comparable solution available that is focused on the specific problems we are working to solve. The need for our solution in the environments we are focused on remains strong and is not being served. I appreciate the dedication of our team, the guidance provided by our shareholders/advisors, and the commitment by our investors as we develop a durable, long-term testing solution to address this important need.”
sabay
3 years ago
FluroTest Announces Pre-Emergency Use Authorization Filing with FDA
Provides Executive Update on Program Progress
Press Release | 07/12/2021
CALGARY, Alberta, July 12, 2021 (GLOBE NEWSWIRE) -- FluroTech LTD. (TSXV: TEST) (OTCQB: FLURF) and wholly owned subsidiary FluroTest Diagnostic Systems ("FluroTest" or The Company), a diagnostics technology leader in high output rapid antigen testing for the detection of SARS-CoV-2 and other pathogens, today announced it has filed its Pre-Emergency Use Authorization (Pre-EUA) Request with the U.S. Food and Drug Administration (FDA). The Pre-EUA submission is the Company’s latest step taken as it seeks authorization of its FluroTest Pandemic Response Platform, designed to facilitate widespread point of access and surge-scale SARS-CoV-2 testing by leveraging the disciplines of robotics automation, biochemistry, fluorescence detection and cloud computing.
Notable updates include:
Pre-EUA Submission Delivery: Early engagement now progressing between FluroTest and the Agency to facilitate a speedy and fulsome final submission. These interactions help guide the FDA’s ability to review and potentially grant the EUA. As described by the FDA, “A Pre-EUA package contains data and information about the safety, quality, and efficacy of the product, its intended use under a future or current EUA, and information about the emergency or potential emergency situation. The pre-EUA process allows FDA scientific and technical subject matter experts to begin a review of information and assist in the development of conditions of authorization, fact sheets, and other documentation that would be needed for an EUA in advance of an emergency and also helps to facilitate complete EUA requests during a current emergency declaration.”
Immunoassay Development: Positive results obtained on initial testing with the use of an inactivated virus. This is a critical step in immunoassay development. Final optimization of the buffer chemistry, to ensure optimal test performance with clinical samples from the field, is being performed. FluroTest immunoassay incorporates the same inactivation detergent that was also used in Gates Foundation funded immunoassays. Inactivation detergent is used in the sample collection device to make the saliva sample safe for transport, storage and handling.
Manufacturing: Pre-production development of three functioning pandemic defense platform systems is now complete. Newly added Biological Safety Cabinets have been built, tested, and approved for use.
Clinical Trial Update: Pending added guidance from the FDA on its pre-EUA submission, FluroTest will proceed with sample collections from six clinical site locations across California, Texas, Colorado, Rhode Island and Florida (with two sites) to determine performance detection results alongside a comparator RT-PCR assay.
Customer Data and Privacy Protection - protocol now established and in place to manage test taker’s required data (e.g., name and link to the saliva sample, interface with all automated equipment and fluorescence reader, test results management, etc.)
“There’s simply no room for error in this process. We’re dealing with sophisticated testing equipment that we’ve engineered to be intuitive enough for a small team of operators to quickly and efficiently conduct high volume public testing. Equally sophisticated is the SARS-CoV-2 virus - now proving to be substantially more contagious and dangerous with the rise of the Delta and Lambda variants,” said Bill Phelan, CEO of FluroTest. “At my direction, I’ve instructed the scientific teams and all partners to spend the time required to fine-tune the system and have all details locked down and in proper working order. Vaccine levels are reportedly plateauing and unfortunately will not reach a tipping point. This virus will be with us for years and the world needs a mass testing solution to help meet this evolving threat and be prepared to face the inevitability of the next one. As we enter into an unprecedented transition period with see-sawing lock-downs and restriction lifts, the need to literally test these new waters remains high. As the virus gains greater exposure to a reopened population, we’re entering our approval home stretch and will not make the mistake of rushing to failure.”
FluroTest continues to work with clinical trials partner Toolbox Medical Innovations (“Toolbox”) to fulfill additional requirements to support final submissions for Emergency Use Authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) and Health Canada for an Interim Order Authorization. Toolbox has expertise in helping organizations surpass each step of the submission process from clinical study design and development, all the way up to regulatory planning and support, allowing them to provide a fast and efficient path to FDA and other approvals for diagnostic products.
Readers are cautioned that, although FluroTest has achieved proof of concept prototype, the testing method and device is still in the pre-approval stage and accordingly FluroTest is not currently making any express or implied claims that the technology can, or will be able to, accurately detect the COVID-19 virus.
sabay
3 years ago
SIX months of waiting.....
Testing was to be carried out in February, then April, then June, and here we are in July.
A "major investor" told me he has learned:
1. FluroTest is real, it works. Though the company obviously did a lousy job of marketing CompleTest products, it is a high quality product, so there's little reason to doubt the effectiveness of FluroTest.
It is able to detect early variants. Detection of delta & epsilon variants will soon be added to the list.
2. The company has halted efforts to sell the rights to CompleTest. Don't know whether this is because they want to hold on to the technology and market it again in the future, or if there was no interest from potential buyers.
Looking at this negatively, one might think the company had no idea what to do with something the cannabis industry needs.
Viewing the positives, the company is devoting all their time and resources, betting the house, on FluroTest.
( insiders hold half of outstanding shares, and not one share has ever been sold, even as the price has dropped 80% from last year's high )
3. There has been NO testing to date! Not sure if the fault lies with FluroTech or Toolbox, but new testing sites are needed.
4. The paperwork for submissions for EUA from the FDA and for authorization from Health Canada is supposedly complete, lacking only clinical test results.
If true, that is good news.
5. MarketSmart, hired to promote FluroTech, featured in a tweet on July 2, is being fired. Whoever is responsible for twitter posts, probably someone from MarketSmart, is a dunce, doing no more than copying old press releases.
Seems that with every new tweet ( hate that word, as childish as Dorsey! ) the sp drops.
6. The execs at FluroTech fully believe that international screening procedures will permanently change, much like travel procedures went to metal detectors, then on to intensive searching & screening after 9/11, and now adding virus detection.
They are convinced that FluroTest will be installed in every int'l airport, train station, and so on.
( if so, there should be more urgency as competitors are being approved )
7. There seems to be some confusion over the testing time - 5 minutes or 10 minutes?
The actual time for the test is 5 minutes, while the time required to obtain the results from start to finish is 10 minutes.
sabay
3 years ago
FluroTest Diagnostic Systems Featured in Grand View Research Report Exploring Growth of COVID-19 Saliva Screening Test Potential
CALGARY, Alberta, June 17, 2021 (GLOBE NEWSWIRE) -- FluroTech LTD. (TSXV: TEST) (OTCQB: FLURF) and wholly owned subsidiary FluroTest Diagnostic Systems ("FluroTest" or The Company), a diagnostics technology leader in high output rapid antigen testing for the detection of SARS-CoV-2 and other pathogens, are pleased to be recognized in Grand View Research’s June 2021 report: COVID-19 Saliva Screening Test Potential Market.
According to the report, the global COVID-19 saliva screening test potential market was valued at USD $2,955.9 billion in 2020 and is expected to reach USD $3,102.55 billion in 2021 expanding at a compound annual growth rate (CAGR) of 4.8% from 2021 to 2028. Key factors that are driving the COVID-19 saliva screening test potential market growth include the advantages of using saliva as a diagnostic specimen, increasing product approvals by regulatory agencies, and a paradigm shift toward point-of-care testing.
The report goes on to state that fluorescence-labeled antigen/antibodies testing enables rapid identification of individuals who are actively contagious and is an effective screening modality for cruise ships, airplanes, sports stadiums, and schools. The combination of vaccination and fast and frequent testing using Fluorescence-labeled antigen/antibodies test holds promising potential in ending the pandemic.
Taking Flight - With Extreme Caution
Grand View Research suggests that amid the ongoing SARS-CoV-2 pandemic, air travel has fallen sharply, leading to a significant reduction in foot traffic at airports. This has severely impacted the economy leading to the screening of passengers becoming a necessity for airports and airlines to curb virus transmission.
According to the International Civil Aviation Organization (ICAO) Air Transport Bureau, an overall reduction in airline passengers was up to 60.0%, i.e., 2, 699 million passengers in 2020. The operating revenue of airlines reduced by approximately. USD 371 billion due to the pandemic. For North America, the revenue was reduced by USD 88 billion. This indicates a high potential of the North American region in using saliva-based COVID-19 screening tests for its economic growth.
“9-11 forever changed our airports and border crossing security checks twenty years ago, but COVID-19 has again surfaced an invisible threat that remains largely unchecked in much of the critical infrastructure that we all take for granted -- even as we slowly attempt to open society back up,” said Bill Phelan, CEO of FluroTest. “News reports suggest that the four Canadian airports that are still accepting international flights are operating at about five per cent of their pre-COVID levels — but with the current COVID-19 public health measures in place, they are at capacity. And in the US, bi-partisan legislation was just introduced calling for the National Coronavirus Commission Act to investigate the vulnerabilities of the public health system and issue guidance for how the American people can be better protected from future pandemics.”
According to Grand View Research, as the number of people visiting public places is increasing and reaching pre-pandemic statistics in a few countries, there is a growing demand for rapid, point-of-care COVID-19 tests to mitigate viral transmission from asymptomatic people. This has enhanced the R&D for the development of simple yet effective saliva-based tests and is expected to create lucrative opportunities for several developers.
Shifting to Saliva-based Testing
The report notes that timeline and scalability challenges pertaining to molecular swab-based SARS-CoV-2 testing are key factors that are prompting consumers to shift to saliva-based testing/screening approaches. The emergence of SARS-CoV-2 variants in South Africa, the U.K., and Brazil, which were observed to be more transmissible than the original strain, solidifies the need for rapid tests. Increased concern over the frequency and spread of these variants is expected to fuel the demand for widespread surveillance and screening. The introduction of the Fluorescence-labeled antigen/antibodies testing Pandemic Defense Platform was found to be effective in these programs. Vaccine administration alone is not likely to be sufficient, rapid testing will be required for mass screening to reopen businesses.
“It’s remains unknown how COVID-19 will continue to affect our lives, which makes it more important than ever to keep safety measures and testing a priority for everyone,” said Dr. Joxel Garcia, FluroTest Chief Medical Officer. “Considering the world population, only 20% have received at least one dose of a COVID-19 vaccine, and only .8% of people in low income countries have had at least a single dose. Antigen testing with FluroTest offers an important accessibility benefit—there’s no need for medically trained personnel, specific chemical supplies, or centralized, expensive lab instrumentation. Testing for COVID-19 must become a routine part of life to keep outbreaks at bay and ensure infection-free environments that are not defined by ‘haves’ and ‘have nots’ or geographic borders.”
FluroTest’s high-volume antigen system is designed to facilitate very fast and accurate point of access testing of individuals by leveraging the disciplines of robotics automation, biochemistry, fluorescence detection and cloud computing. High-risk pandemic environments supported will include athletic stadiums and performance venues, airline and cruise ship terminals, corporate campuses, manufacturing facilities, schools and colleges, hospitals and large healthcare facilities, transportation and distribution hubs and other large businesses. FluroTest is presently engaged in clinical trials and plans submissions for Emergency Use Authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) and from Health Canada for an Interim Order Authorization.
Readers are cautioned that, although FluroTest has achieved proof of concept prototype, the testing method and device is still in the pre-approval stage and accordingly FluroTest is not currently making any express or implied claims that the technology can, or will be able to, accurately detect the COVID-19 virus.
MADDSTACKER
3 years ago
Major news .. imho
Former US Assistant Health Secretary Dr. Joxel Garcia Joins FluroTest as Chief Medical Officer and Executive Team Member
Former US Assistant Health Secretary Dr. Joxel Garcia Joins FluroTest as Chief Medical Officer and Executive Team Member
PR Newswire
CALGARY, AB, June 10, 2021
New CMO Preps Aggressive SARS-CoV-2 Global Testing and Education Agenda as Company Confirms Variant Detection Capabilities in High-Volume Testing System
CALGARY, AB, June 10, 2021 /PRNewswire/ - FluroTech LTD. (TSXV: TEST) (OTCQB: FLURF) and wholly owned subsidiary FluroTest Diagnostic Systems ("FluroTest" or The Company), a diagnostics technology leader in high output rapid antigen testing for the detection of SARS-CoV-2 and other pathogens, are pleased to announce the appointment of former U.S. Public Health Service and Four-Star Admiral Joxel Garcia, M.D. to Chief Medical Officer (CMO). Dr. Garcia will be responsible for expanding FluroTest's domestic and international reach while driving the advancement of the Company's diagnostic testing solutions. Previously, Dr. Garcia had been functioning in an advisory capacity to the Company as announced April 6, 2021.
FluroTest Logo (CNW Group/FluroTech Ltd.)
FluroTest also now confirms that its testing system will detect primary variants of concern from live viral samples circulating today. The variants detected include B.1.1.7 commonly referred to as the 'U.K.' or 'Alpha' variant, B.1.351 commonly referred to as the 'South African' or 'Beta' variant and P.1 and P.2 or 'Brazilian' or 'Gamma' variants. Under Dr. Garcia's guidance, FluroTest is closely following International Health Regulations (IHR), the only international and legally-binding treaty empowering the World Health Organization (WHO) to act as the main global surveillance system to control the spread of COVID-19 and other pathogens across 196 countries.
"Testing will remain absolutely essential to reopening society and reinvigorating social and economic activity without fear of risk," said Dr. Joxel Garcia, FluroTest Chief Medical Officer. "Globally, the pandemic is actually advancing as more hostile virus variants are taking root where vaccination efforts are slow or inconsistent. Having personally helped construct the IHR during my service with the WHO, we know that strengthening virologic global surveillance at local and national levels, as well as international ports of entry like airports and ground crossings, remains a big part of a comprehensive strategy to control COVID-19. I'm actively speaking with global health leads across government and industry about these issues, as the opportunity to utilize FluroTest to support IHR, open commerce and trade between nations and create greater health equity are real and are available now."
An internationally respected healthcare leader in public health administration, equity and education, Dr. Garcia will increase his support and visibility in FluroTest business operations, reporting directly to CEO Bill Phelan. As the 14th Assistant Secretary for Health, Dr. Garcia operated as the lead advisor on national global public health and science matters for the Secretary of Health. He has also served as United States Representative to the World Health Organization Executive Board, and Deputy Director of the Pan American Health Organization, Regional Office for the Western Hemisphere for the World Health Organization during the 2003 SARS epidemic.
"Joxel's desire to assume the role of Chief Medical Officer is significant, as we can further leverage his time, expertise and relationship-building efforts to expand our presence in testing markets around the world," said Bill Phelan, CEO of FluroTest. "The fragility of our social and economic infrastructure continues to fuel our determination to help reopen society safely through mass testing. FluroTest is more than a testing solution, as it helps bring health equity to all people, providing fast, reliable, efficient and cost-effective testing of COVID-19 and other emerging viruses."
FluroTest's high-volume antigen system is designed to facilitate very fast and accurate point of access testing of individuals by leveraging the disciplines of robotics automation, biochemistry, fluorescence detection and cloud computing. High-risk pandemic environments supported will include athletic stadiums and performance venues, airline and cruise ship terminals, corporate campuses, manufacturing facilities, schools and colleges, hospitals and large healthcare facilities, transportation and distribution hubs and other large businesses. FluroTest is presently engaged in clinical trials and plans submissions for Emergency Use Authorization ("EUA") from the U.S. Food and Drug Administration ("FDA") and from Health Canada for an Interim Order Authorization.
Readers are cautioned that, although FluroTest has achieved proof of concept prototype, the testing method and device is still in the pre-approval stage and accordingly FluroTest is not currently making any express or implied claims that the technology can, or will be able to, accurately detect the COVID-19 virus.
About FluroTech (TSXV: TEST) (OTCQB: FLURF)
The goal of FluroTech's research and technology is to develop detection methods which are high speed, sensitive, specific and easy-to-use. By combining FluroTech's proprietary spectroscopy-based technology with laboratory robotics automation and cloud computing, FluroTech, through the application of its technology and investment in FluroTest Diagnostics Systems Ltd. ("FluroTest"), the interests in which have been disclosed in previous press releases, has created a unique solution addressing the current and future pandemics. Using technology that was first developed at the University of Calgary, the FluroTest SARS-CoV-2 test is designed to identify patients with active virus infection; this is not necessarily the case for most of the currently approved tests that are meant to identify patients with SARS-CoV-2 nucleic acid.
About FluroTest Diagnostic Systems Ltd.
FluroTest, a diagnostics technology leader in surge-scale rapid antigen testing for the detection of SARS-CoV2 and other pathogens, is developing a pandemic defense and economic recovery system purpose-built for businesses and special-needs populations requiring fast and highly accurate testing for significant numbers of people. Unlike individual or low-throughput tests, FluroTest's system is designed to be well-suited for high-traffic, high-risk pandemic environments including schools and colleges, hospitals and large healthcare facilities, athletic stadiums and performance venues, airline and cruise ship terminals, corporate campuses, shopping centers, manufacturing facilities, transportation and distribution hubs and other large business and retail locations. Created to support executive business continuity efforts and public well-being, the system combines and leverages the disciplines of robotics automation, biochemistry, fluorescence detection and cloud computing -- processing thousands of tests per hour while delivering accurate, digitally verifiable results to a test taker's mobile device within 5 minutes. To learn more, visit FluroTest.com.
Cautionary Statement Regarding Forward-Looking Information
This news release contains "forward-looking information" within the meaning of Canadian securities legislation. Forward-looking information generally refers to information about an issuer's business, capital, technology or operations that is prospective in nature, and includes future-oriented financial information about the issuer's perspective financial performance or financial position. The forward-looking information in this news release includes disclosure about the ability of the Company's testing devices to accurately and quickly detect COVID-19 and to process large numbers of samples in short time frames, the benefits of and demand for the Company's testing devices, its efforts to obtain approval of the FDA and Health Canada, its potential partnership with a major U.S. based healthcare system and finalizing plans to conduct clinical trials and its intent to amalgamate with FluroTest Diagnostics Systems Ltd which owns a 100% interest in FluroTest LLC. The Company made certain material assumptions, including but not limited to prevailing market conditions and general business, economic, competitive, political and social uncertainties, the ability to obtain FDA and Health Canada approvals, the demand for its COVID-19 testing devices and their ability to perform as expected, its potential partnership with a major U.S. based healthcare system and finalizing plans to conduct clinical trials and its intent to amalgamate with FluroTest Diagnostics Systems Ltd which owns a 100% interest in FluroTest LLC and to obtain the regulatory approvals required in connection with the same, to develop the forward-looking information in this news release. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements.
Actual results may vary from the forward-looking information in this news release due to certain material risk factors described in the Corporation's Annual Information Form under the heading "Risk Factors", the failure to develop and commercialize its testing devices in a timely manner or at all, the failure to recognize the anticipated benefits from the devices, the failure to obtain FDA or Health Canada approval for its products, the risk that regulatory approvals will not be received and the risk that changing circumstances will result in the decrease in demand for FluroTest's products. The Company cautions that the foregoing list of material risk factors and assumptions is not exhaustive.
The Company assumes no obligation to update or revise the forward-looking information in this news release, unless it is required to do so under Canadian securities legislation.
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 of this release.
This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities. The securities described herein have not been and will not be registered under the United States Securities Act of 1933, as amended, or the securities laws of any state and may not be offered or sold within the United States or to or for the benefit or account of U.S. persons, absent such registration or an applicable exemption from such registration requirements.
Cision View original content to download multimedia:www.prnewswire.com/news-releases/former-us-assistant-health-secretary-dr-joxel-garcia-joins-flurotest-as-chief-medical-officer-and-executive-team-member-301309551.html
SOURCE FluroTech Ltd.
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