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  1. Stockbrood 16 juni 2020 16:54
    SEATTLE, June 16, 2020 /PRNewswire/ -- Immunexpress, Inc., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, has been awarded a grant from the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), of up to $599,549 to develop and pursue U.S. Food and Drug Administration Emergency Use Authorization (EUA) for the host response sepsis test SeptiCyte® RAPID which has the potential to assess and triage patients with escalating signs of COVID-19 disease. With the funding from BARDA, Immunexpress expects to complete development work necessary to validate its role as a triage tool to help identify COVID-19 patients with an elevated risk for viral or secondary bacterial sepsis.

    The ongoing COVID-19 pandemic underscores the unmet need for technologies that efficiently discriminate patients with mild infection from those that have an elevated risk for serious complications, including viral or secondary bacterial sepsis, especially when critical medical resources are in short supply. In a recent study of the risk factors associated with COVID-19 mortality, sepsis was the most frequently observed complication1. The early diagnosis of bacterial and viral sepsis with SeptiCyte® RAPID, including the immediate and overwhelming global need to triage COVID-19 patients with worsening prognoses, will ensure rapid initiation of sepsis management protocols increasing the potential to save lives and appropriately assign limited resources.

    "The COVID-19 pandemic has exacerbated the need for rapid identification and triage of COVID-19 patients at risk of sepsis," stated Rolland D. Carlson, Ph.D., Chief Executive Officer of Immunexpress. "Equipping clinicians with the best tools to manage patients quickly, safely and appropriately is the first step in addressing the high mortality rate associated with sepsis infection in COVID-19 patients."

    About SeptiCyte® RAPID
    SeptiCyte® RAPID is a gene expression assay using reverse transcription polymerase chain reaction (PCR) to quantify the relative expression levels of host response genes isolated from whole blood collected in the PAXgene® Blood RNA Tube. SeptiCyte® RAPID is used in conjunction with clinical assessments, vital signs and laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis. SeptiCyte® RAPID generates a score (SeptiScore™) that falls within one of three discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte® RAPID is intended for in-vitro diagnostic use and is used on the Biocartis Idylla™ System.

    SeptiCyte® RAPID is CE Marked as a near-patient sample-to-answer test in European Union (EU) member countries and those harmonized with the EU IVD Directive (98/79/EC).

    About Immunexpress
    Immunexpress is a molecular diagnostic company, founded in Australia and based out of Seattle, Washington, USA, committed to improving outcomes for patients suspected of sepsis. Immunexpress' SeptiCyte® technology can assess a patient's immune response by quantifying and analyzing gene expression signatures from whole blood, providing actionable results in about an hour to guide the physician in optimizing patient management decisions. SeptiCyte® RAPID combines SeptiCyte® technology with the Biocartis' Idylla™ platform*, empowering clinicians to swiftly differentiate infection positive (sepsis) from infection negative systemic inflammation in patients suspected of sepsis. This powerful combination of technologies enhances certainty for early sepsis diagnosis, to improve clinical outcomes and lower healthcare costs.

    In March 2020, Immunexpress received CE Marking of SeptiCyte® RAPID and announced a long-term commercialization partnership with Biocartis in Europe.

    For more information visit www.immunexpress.com/. Follow Immunexpress on Twitter and LinkedIn.

    *Immunexpress is licensed to use the Idylla™ trademark from Biocartis NV.
  2. forum rang 4 Flatlander 16 juni 2020 21:19
    Stockbrood

    There is an interesting competition between ImmunExpress and Inflamatrix to get a Host response Sepsis test to the market. Inflamatix says their HostDx test will be available sometime in 2021. Like Septicyte, their lab based test must have too long of a TAT to be of use to anyone. Their test is based on 20 genes. They have gotten serious funding from BARDA, enough to make today's immunexpress announcement look like chump change. Several articles authored by Inflamatix co-founder and CEO Tim Sweeney have been quite critical of theImmunexpresses test. Specifically they claim that the test is not very accurate for acute respiratory infection related sepsis. However, they did not back up the assertions with much in the way of facts. They could be right, or they could be very frustrated that they are a year behind BCART/ImmunExpress Septicyte. I think we need to see the results of the COVID Validation that is underway now.

    Nothing is ever easy.

    FL

    www.fiercebiotech.com/medtech/inflamm...

    inflammatix.com/wp-content/uploads/20...
  3. Tryck 16 juni 2020 21:57
    Interesting developments!

    Though the market does not really seem to respond to the news.

    Then again, 600K $ is indeed peanuts in this market, as FL mentions.

    Q2 is coming to an end on 30 June, it's a pity we have to wait until September for an update.

    I expect Biocartis to be the one to make up for all my losses in the stock market :D Some wishful thinking.

  4. forum rang 4 Flatlander 16 juni 2020 22:08
    Pumske

    Sepsis diagnostic tests are a major unmet need, the competition is fierce. Immunexpress has first mover advantage in the Host Response Dx space, but their test may or may not be sufficiently sensitive to act as a good COVID triage tool. From BCART's perspective, a big move up could occur in the next couple of months if the results of the COVID Triage validation testing are positive. I don't think good news is priced in at the current share price, therefore, BCART should not fall much it the validation results are lacking. If they are good there is considerable upside, especially with today's announcement about successful steroid treatment for the worst cases.

    On the business front, I believe it is likely that BCART has already started shipping this test in the EU. I don't expect an announcement on the number of consoles shipped as well until November or so. If we are lucky, maybe a bit of an update in Sept when they discuss 1st half results.
    FL
  5. forum rang 4 Flatlander 17 juni 2020 23:42


    There are a couple interviews on the Wondfocartis site that speak to the utility of the Idylla MSI and EGFR assays. I wish I could cut and paste the few pertinent paragraphs but the translation program did not allow it.
    FL
    www.wondfocartis.com/news/aid/70/cid/...

    www.wondfocartis.com/news/aid/69/cid/...

    www.wondfocartis.com/news/aid/66/cid/...
  6. iubere 18 juni 2020 09:03
    Hi,
    Long time reader and just wanted to say thanks for all the fundamentally insightful information you guys have been providing here. I have learned a lot by reading this forum and really see major potential in biocartis' tech. Molecular biology is on the rise in labs all over the world so let's hope the sales team can deliver.
  7. forum rang 4 Flatlander 18 juni 2020 15:13
    Hi iubere

    BCART remains my favorite speculation. In most of biotech there are bimodal outcomes. Either the drug candidate gets approved and the price skyrockets or it gets rejected or more information is requested and it tanks. In the case of BCART there are many shots on goal that will play out in the next two years. The share price and market cap are so low that BCART has become a bit of a lottery ticket (a low priced way of playing a sizable and growing market opportunity). Yet the technology has been validated that it is far from a Theranos situation.

    There are a tremendous number of ever changing factors (regulatory registration reviews, partner decision making, competition developments etc.) but the overall product capabilities and the overall expansion of the MDx market opportunity remain unquestioned. At this point. I'm uncertain as to which assay rises to the point of becoming the "Killer Ap" that drives Idylla growth, or whether the pandemic and need for social distancing will accelerate adoption of the platform. But I'm pretty certain that Idylla will find a strong market once it can clear some of the registration hurdles that will make it more available for wider use.

    Regards
    FL

  8. joe123 20 juni 2020 10:03
    quote:

    Flatlander schreef op 18 juni 2020 15:13:


    Hi iubere

    BCART remains my favorite speculation. In most of biotech there are bimodal outcomes. Either the drug candidate gets approved and the price skyrockets or it gets rejected or more information is requested and it tanks. In the case of BCART there are many shots on goal that will play out in the next two years. The share price and market cap are so low that BCART has become a bit of a lottery ticket (a low priced way of playing a sizable and growing market opportunity). Yet the technology has been validated that it is far from a Theranos situation.

    There are a tremendous number of ever changing factors (regulatory registration reviews, partner decision making, competition developments etc.) but the overall product capabilities and the overall expansion of the MDx market opportunity remain unquestioned. At this point. I'm uncertain as to which assay rises to the point of becoming the "Killer Ap" that drives Idylla growth, or whether the pandemic and need for social distancing will accelerate adoption of the platform. But I'm pretty certain that Idylla will find a strong market once it can clear some of the registration hurdles that will make it more available for wider use.

    Regards
    FL

    Misschien heeft Rarezot een inzicht hoe het er tegenwoordig in de productieafdelingen aan toe gaat.Spijtig dat we niets meer van hem horen of lezen op dit forum.Rarezot was de geschikte persoon die ons kon informeren via zijn profesionele werking met collega,s die bij Biocartis werken.
    Dus bij deze,Rarezot een oproep om terug uw interressante quotes neer te pennen op dit forum.
  9. forum rang 4 Flatlander 20 juni 2020 18:30
    quote:

    joe123 schreef op 20 juni 2020 10:03:


    [...]


    Joe

    Your right, it would be good to here frome Rarezot again. Haven't heard much from him since his YouTube presentation on BCART. I'd like to ask him who is the most likely partner for Inflamatix to team with for its Sample to Answer platform for Host Dx Sepsis test. I'm guessing that it will be done by
    Invetech. I think that monitoring the host response is a great way to test for Sepsis, I'm just waiting to see the validation results for Septicyte use for COVID Triage.

    FL


    www.invetechgroup.com/approach/?utm_s...
  10. forum rang 4 Pommeke 23 juni 2020 20:51
    In Q1 2020 zette de Biocartis joint venture met Guangzhou Wondfo Biotech
    Co., Ltd. (‘China JV’) de voorbereiding verder van de commercialisatie van
    het Idylla™ platform in China met een eerste focus op de verwezenlijking
    van lokale productiecapaciteit en productregistraties.

    In Japan werkten distributiepartner Nichirei Biosciences en Biocartis in Q1
    2020 verder aan de lopende Idylla™ test IVD registratie voorbereidingen
    voor de Japanse markt.

    Dan gaat ook deze nagemaakt worden zoals andere daar ?
    Ben je ook alles kwijt?
    :)

  11. forum rang 4 Flatlander 24 juni 2020 00:04
    Pommeke

    Yes, when I tried to cut and paste sections of the translated interview it would not allow it, so I just copied the entire link. We could use some good news out of Asia. Oncology MDx testing is likely to be very low during the 2nd quarter. I'm guessing that this will have a ripple effect on BCART.

    The board has gotten kind of slow while we are in the summer doldrums.

    Regards FL
  12. brightlight 24 juni 2020 06:40
    quote:

    Flatlander schreef op 23 juni 2020 15:05:


    healthprofessionalradio.com.au/immune...

    Interview with Rollie Carlson CEO of ImmunExpress

    A coupe take aways:
    About 700 Idylla Consols in Europe;
    Will be reimbursed as part of ER ICU admission;
    Expect FDA approval in 3rd Qtr.

    FL

    FL
    Excellent link, thanks.
    Good to hear FDA approval is still on track for Septicyte-Rapid.
    The most important take-away for me is that at Immunexpress the focus seems to be on Septicyte-RAPID rather than -LAB. This is good news for Bcart.
    Also I was surprised to find the bulk of the installed Idylla base is still in Europe (over half of the total). The installed base in the US still has a lot of room to grow, then, so it seems
    BL
  13. forum rang 4 Flatlander 24 juni 2020 14:55
    BL

    I took the Septicyte Rapid point as a given since Septicyte Lab at 4-6 hr TAT misses the Sepsis treatment initiation time guideline.

    The septicyte rapid launch potential for success really hinges on the validation study results for use in triaging COVID patients. I'm not sure whether the results will come 1st from the US or from the EU. The Septicyte lab reviews are mixed. Some of the studies have suggested that it is not effective for acute respiratory infections. However, some of these papers are authored by the co-founder of Inflamatix a company that is hoping to launch HostDx its own rapid host response sepsis test next year. I'd be more inclined to believe their studies if they provided specific area under the curve stats for this subgroup. They did not so I'm uncertain how Septicyte Rapid is likely to perform for this subgroup. I think we will see results of the validation study in the next couple months.

    On other fronts, Kevin Conroy (Exas) interviews seem to tout the recently acquired Paradigm analysis as their approach to accelerating the delivery of precision oncology products such as OncoType DX Breast. I'm uncertain how this system gets them around the problems of a centralized lab and shipping of tissue samples. I hope the partnership agreements have sufficient flexibility that if EXAS does not execute on launching OncoType DX on Idylla, BCART can seek other partnerships for similar products. This is another one of the moving parts we will need to watch play out this year. Hopefully, I'm reading too much into the apparent delays in the validation studies.

    Perhaps we will get news on the on the Asia registration Front (China and Japan), we are a couple months short of the two year anniversary of Wondfu agreement. Seems like it should begin to bear fruit soon.

    FL
  14. forum rang 4 Flatlander 24 juni 2020 15:17
    www.statnews.com/2020/06/22/lack-of-r...

    Pretty good article discussing the urgent need for rapid sepsis diagnostic tests. The need underscored in the article summarizes why I believe their could be a large market for Septicyte Rapid if it is validated as effective for acute respiratory infections.

    FL
  15. brightlight 25 juni 2020 14:29
    FL
    Indeed, we are still waiting for a clear sign from the part of Exas that they will proceed with Idylla. Why can't these doctors ever be clear about anything? I suppose it is in their genes.
    Meanwhile the shareprice is drifting lower once again, as was to be expected, in the absence of news. However there remain still so many unanswered questions, around which Bcart could easily produce a press-release:
    - the status of the development of the Covid test
    - the status of (RUO) sales in China/ Japan
    - the status of the studies leading up to the start of the full approval process for tests in China/Japan (how much longer before the approval process can be set in motion)
    - an excellent press moment could be the announcement of the first Idylla sold in either of these countries. I suppose that moment has already passed. Why not announce it to the world?
    - are there still regulatory hurdles preventing wider RUO sales to other than the labs involved in the studies?
    - what is the status on the sales start of Septicyte RAPID in Europe. We are 3 months since the launch already, a perfect moment to provide an update it would seem
    - an update on the impact of Covid19 on sales would also be welcome
    - what are the plans with regards to getting full approval for lung cancer tests in the States. Is there a timeline? Why does there appear to be no focus on that since, by their own admittance, lung cancer is the biggest market in the States.
    So many questions ... . I am sure you can add a trainload too.
    BL
  16. forum rang 4 Flatlander 25 juni 2020 16:17
    quote:

    brightlight schreef op 25 juni 2020 14:29:


    FL
    Indeed, we are still waiting for a clear sign from the part of Exas that they will proceed with Idylla. Why can't these doctors ever be clear about anything? I suppose it is in their genes.
    Meanwhile the shareprice is drifting lower once again, as was to be expected, in the absence of news. However there remain still so many unanswered questions, around which Bcart could easily produce a press-release:
    - the status of the development of the Covid test
    - the status of (RUO) sales in China/ Japan
    - the status of the studies leading up to the start of the full approval process for tests in China/Japan (how much longer before the approval process can be set in motion)
    - an excellent press moment could be the announcement of the first Idylla sold in either of these countries. I suppose that moment has already passed. Why not announce it to the world?
    - are there still regulatory hurdles preventing wider RUO sales to other than the labs involved in the studies?
    - what is the status on the sales start of Septicyte RAPID in Europe. We are 3 months since the launch already, a perfect moment to provide an update it would seem
    - an update on the impact of Covid19 on sales would also be welcome
    - what are the plans with regards to getting full approval for lung cancer tests in the States. Is there a timeline? Why does there appear to be no focus on that since, by their own admittance, lung cancer is the biggest market in the States.
    So many questions ... . I am sure you can add a trainload too.
    BL





    BL

    The WonduCartis site has a tab that lists all of the Idylla content that is available for RUO. So given that the content is listed on the Website and they are doing presentations at technical conferences with considerable interest (supposedly over 1000 stopped by the booth at a recent conference). Therefore I'm certain that the initial China sales occurred some time ago. So essentially, in China Idylla is in the same launch mode as in the U.S. Things may actually be better off there since they have Covid under better control than the U.S. (only 5 more months till we Dump Trump). Japan is much less clear. Since the November PR, no information has been provided. The Nicherei site does not advertise Idylla content (not that I've seen, anyway).

    When I first started following BCART in 2018 (as a GHDX shareholder) they were more transparent and put out more PR. The space has become hyper competitive and by automating labor intensive Dx, they are sure to be meeting a lot of resistance due to competition, job disruption, etc. I think they toned down the PR statements to minimize getting front run by competitors (Fisher, Illumina, Perkin Elmer, Roche, Agilent etc.) and getting push back from lab workers afraid of job displacement. The reopening after the initial Covid shutdown may actually present a marketing opportunity.

    As I've mentioned before, I'm committed to holding until Idylla gets approved for diagnostic use in the US and Asia. If after a few critical product registrations(MSI, EGFR, KRAS) they cannot find traction in the POC environment, I'll admit that it is time to sell. For now we seem to sit endlessly in limbo waiting for the registrations that would unlock worldwide launch of a labor saving, time saving medical device. I totally misjudged the time required to secure registration approvals. I read the positive head to head performance studies and the user technical papers and thought quick approval was a no brainer.

    FL

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