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LexaGene Holdings Inc. (LXXGF)

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0.4133-0.0115 (-2.71%)
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  • J
    Jeff
    I wonder how long it will take the US Army to decide they want LexaGene to deliver a lot more machines?

    Dr. Jack Regan, CEO and Founder of LexaGene stated, “We are now progressing to the second stage of the Army CRADA, during which the MiQLab’s sensitivity and quantitative ability for biothreat detection will be tested at the Army’s DEVCOM Chemical Biological Center at Aberdeen Proving Grounds, Maryland. Due to the Army’s facility and personnel availability, these studies are planned to begin during the week of November 15th, and we will ship multiple systems to the Army for this start date.”
  • J
    John
    December 7-8
    LexaGene selected as a Best in Show Spotlight company for the 47th Annual Petcare Innovation Summit

    https://www.proactiveinvestors.com/companies/news/964446/lexagene-selected-as-a-best-in-show-spotlight-company-for-the-47th-annual-petcare-innovation-summit-964446.html
  • G
    Golden Crown Dharma King
    GREAT NEWS! They're going for the whole enchilada!

    LexaGene Intends to Pursue Full Panel Pathogen Testing through the FDA
    November 24, 2021 16:00 ET | Source: LexaGene Holdings Inc

    ...
    BEVERLY, Mass., Nov. 24, 2021 (GLOBE NEWSWIRE) -- LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (“LexaGene” or the “Company”), a molecular diagnostics company that has commercialized an instrument for automated multiplex PCR testing, today announced it intends to pursue both 510k clearance and CLIA-waiver from the FDA to utilize the full potential of the MiQLab System™ for syndromic testing at the point of care.

    Syndromic testing allows medical providers to simultaneously test patient specimens for multiple pathogens that produce overlapping signs and symptoms. MiQLab’s broad multiplexing provides this capability and also allows for testing other clinically important markers such as antimicrobial resistance genes. Antimicrobial resistance is widely considered to be the next global pandemic.1 Scientists estimate that drug resistant pathogens will kill ~10 million people per year by the year 2050.2

    Dr. Jack Regan, LexaGene’s Founder and CEO stated, “One of the hardest challenges in medicine is to rapidly identify, at the point-of-care, the exact cause of complex and difficult to treat infections.3 We’ve developed the MiQLab to tackle this challenging problem. It is capable of processing sample types that traditionally inhibit PCR (e.g., urine and fecal samples) and screens for up to 27 targets including drug resistance markers so it can be used in the fight against superbugs. We believe the MiQLab will be on the forefront of helping clinicians accurately diagnose and treat their patients at the point of care so that a pandemic caused by antimicrobial resistant pathogens can be avoided. Similarly, syndromic panels like respiratory or gastrointestinal panels will enable clinicians to more rapidly and conveniently diagnose infectious diseases, enabling earlier treatment and prevention.”

    The Company has been steadily working to meet FDA requirements for human clinical diagnostics. The progress we have made during the pursuit of EUA for COVID-19 testing has brought the Company closer toward meeting the more extensive requirements of the traditional premarket review pathway, which will be required for the Company to offer broad panel pathogen testing at the point of care. The FDA recently provided industry-wide guidance4 and based on this guidance and direct communications with the agency, the Company has decided it will no longer pursue an EUA application for COVID-19, but instead pursue 510k and CLIA-waiver for broad-panel pathogen testing, thereby allowing the Company to focus on providing the MiQLab technology for its intended use of syndromic testing at the point of care.

    LexaGene’s MiQLab system is unique in that it is a flow-through PCR system. To LexaGene’s knowledge, the FDA has never received an application for a flow-through PCR system for use in human clinical diagnostics. Until the FDA grants LexaGene’s system authorization for human clinical diagnostics, all work using LexaGene instruments is classified as Research Use Only.

    The Company continues to sell its technology into veterinary hospitals, bio-pharmaceutical manufacturers, and other open-access markets.
  • J
    John
    Does anyone know of a database for the US Army CRADA's? I would like to read the specifics of the LexaGene US Army CRADA. I am not sure if this is public knowledge data or classified. The PR mentioned multiple MiQLabs being shipped for a Nov 15 test start. I wonder if it is for Bio-terror only? or Is it also for human Clinical diagnostic testing? Wondering why multiple machines. I guess I'll just wait to read a PR about the testing some time in the future.
  • J
    John
    In my opinion the 2022 funding must be announced to allow the share price to move. There are too many unknowns for the financials. Will it be a non-diluted funding? Will there be a non-diluted funding through a US government grant? Will there be non-diluted funding through a government contract? Is a large PO close to reality? Will the shelf prospectus be utilized? Is there another funding plan in the works for LexaGene? In addition to the funding unknowns the BioTech sector of the market is struggling. The BioTech high point was in February 2021 and Biotech has been on a downward trend since. The potential LexaGene has created will be a great value asset once the BioTech sector starts to move upward. I am long on LXXGF and look forward to the future of the LexaGene company. What are your thoughts?
  • M
    Michael
    At present it is only lexagene's "intention to pursue" 501 and CLIA per the Fluff PR put out. No mention of new applications ot timetables. As for now it it dimply Lexagene's "intention" .

    And Dr' Regan actally thinks that will get the attention of the market? Reminds me of the paperwork in his hand ready to submit to FDA two years ago that was never submitted.

    He'll put anything out to get attention it seems, except he still won't tell shareholders why veterinarians are still not buying Miq's after a year and a half on the market. He just won't tell.................GLTA
  • N
    Nova461
    Its what we've wanted all along. The MiQLab approved for human testing. This is very good news
  • M
    MikeyStanLies
    Lexagenes latest PR is good news for us and the company. There are many Covid tests out there. There are few that can not only tell you it’s not COVID but can tell you exactly which pathogen is present. So rather than saying you’re just Covid negative, the doctor can say that it’s an RSV and treat your child properly and quickly!
  • J
    John
    Wow! Full 510K. I did not expect LexaGene to go after full 510K approval for another 2 to 3 years.
  • M
    MikeyStanLies
    Let’s dispel a few myths here. As you can see from the conversations, people bring up the accuracy of the MiQ for Covid testing (and other pathogen detection as well). There is no doubt that the MiQ is accurate when testing for Covid. But the rats on this board bring up the fact that it takes two hours for a test, which is true. Then they say “who would want to wait two hours” This is where the rats do what rats do best. They try and compare apples to oranges in an effort to make the MiQ look bad. Here’s the deal. I’ve been subject to rapid and PCR testing, and I’ve also been involved in doing the Covid swabbing in my town. When you are rapid tested in the doctors office you are warned that rapid antigen tests are not very accurate and treat yourself like positive until the PCR results return. The rapid tests are flawed, but it’s the only way. When we swab patients in town, we have to wait for a lab to pickup, process, and disseminate the information. Now imagine a doctors office with a few MiQS that untrained assistants can use to provide an accurate, two hour result to positively confirm a Covid result. But of course the rats don’t get this….
  • G
    Guy
    Bruce is working hard to produce fear. Think about why somebody would waste time on yahoo doing this. There are very few logical reasons.
  • s
    stan
    The idea for making a separate panel for Anti-Microbial Resistance alone is a sound idea is it not? Because it could be sold as a separate panel to both the veterinary and human clinical diagnostics. A clinic(vet or human) with a known pathogene sample can place that sample in a MiQLab and in 2 hours knows what's it's AMR? In here the company has a product that can be sold to vet clinics now without regulatory approval and is all ready to be sold to human clinics once regulatory requirements are met. But only if the MiQLab really works. Does it really work?
  • M
    MikeyStanLies
    Another shot of reality about the MiQ lab….

    The MiQLab system uses real-time polymerase chain reaction (qPCR) to simultaneously screen for up to 27 targets with high sensitivity and specificity and return results in ~2 hours.

    Amazing…
  • J
    John
    Remember to vote your proxy shares for the LexaGene December Shareholders meeting. My voting forms were in my investment account messages folder.
  • J
    Joe
    One needs to ask why not get the EUA and then go after 510k?

    510k will take years and EUA was relatively quick once the application was submitted per Jack.

    The EUA would simply validate the technology to help generate value.

    Feels like I’ve been scammed.
  • M
    Michael
    My thoughts John, with the very dissapointing introduction of the Miq to the vet market over a year and a half ago, A stock offering which I think is very imminent, not only will be a very hard selling job, but will be highly dilutive to stockholders. Your suggestion of the variad non diluting funding methods, ie, gov't grants or contracts a highly unlikely possibility due to Lex's dismal track record and history of stock dilution.

    Unless Dr' Regan can convince the market of a new road to profitabilty, I fear a steady decline of the stock price, and an absense of new investors. My thoughts since you ask...................GL
  • J
    John
    For the Long shareholders....Do you remember this meeting 3 years ago? The Department of Homeland Security has been in discussions with Dr. Regan for quite a while. Read the Old news and think of what is happening today with the US Army. (2+2 does really =4). The potential for LexaGene is huge with the US Government.
    https://www.hstoday.us/federal-pages/dhs/lexagene-meets-with-dhs-cwmd-office-on-developing-bio-threat-detection/

    KEEP IN MIND THIS IS A THREE YEAR OLD ARTICLE
    The recent discussion centered around modifying LexaGene’s technology for bio-threat surveillance and other homeland security-related operations.
    The recent discussion centered around modifying LexaGene’s technology for bio-threat surveillance and other homeland security-related operations.
    www.hstoday.us
  • P
    Philip
    .....ISPC doubles up with contracts to just send covid samples to multiple Federal and private orgs and reseearch centers all over , where as LXXGF can effectively ID many pathogens on the spot , open sourced too.
    .....What a world !!!! Hoping this happens to LXXGF soon !!!
  • K
    Ken
    Success of Covid antiviral pills hinges on access to speedy, accurate tests! Golden opportunity for Lexagene!
  • J
    John
    I do not mute anyone on this board. I value all opinions whether positive or negative toward LexaGene. I also investigate any new claims made, again whether positive or negative. I delve deep with my investigation into the stocks I hold shares in, and appreciate an unbiased dialog. I do however, despise non-truths, false accusations, blatant bashing and false pumping. We are all here to create wealth and I prefer holding long as an investor for my wealth creation. Some people are swing traders, day traders or short traders. We should all learn facts from each other. I recommend folks bring back, civility, truthfulness, and facts to the forum. Opinions are great as well, since we all have them. There are people who will not post on the forum, due to all of the animosity, and that is not good for any of us.

    My news to assist in everyone's due diligence, concerning the newest member of the Board of Directors...

    https://www.vetmed.ucdavis.edu/news/uc-davis-veterinary-hospital-celebrates-dr-jane-sykes-leadership