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  1. Flatlander 2 juli 2020 22:17
    BL

    I've don'e more reading on Sepsis and I'm putting the chances of the COVID validation study success as a triage tool at 85-90%. Septicyte was designed to utilize biomarkers (LAMP1, CEACAM4, PLA2G7 and PLAC8) emitted from the endothelial cells that are located on vascular system lining. These endothelial cells modulate and control the bodies response to pathogens such as bacteria, fungus and viruses. These cells are the epicenter of the COVID virus's attack on the body. Systemic endothelial cell activation from this attack leads to hypotension and edema formation causing inadequate tissue oxygenation. This is precisely the symptom described in the majority of COVID ICU patients (struggling to get oxygen). Initially, they treated this lack of oxygen by putting the patient on a ventilator trying to force air through the lungs. This is of minor help since it is not the lungs but the endothelial cell connection between the lungs and the blood stream that is the problem. One of the responses of the endothelial cells when it is injured or is dying off is to send out a signal to to the bodies immune system to try to seal off the pathogen by isolating the endothelial cell connection to the brain, the heart etc. The body does this by promoting platelet production and coagulation leading to the the formation of blood clots that have been described in numerous COVID patient autopsies. Reportedly, the number of clots in COVID patients is 10 times anything Drs have seen with any other respiratory infection. Because Septicyte is designed to track the enzymes that trigger the host response (initiated by the endothelial cells) that results in clotting. This clotting is very pronounced in COVID Sepsis cases. Therefore, I think the test has a high potential for success in the ongoing (or maybe just completed) COVID Triage validation study. The early MARS study that suggested that Septicyte did not act as a good indicator for Sepsis induced by Acute Respiratory Distress is likely because the infection was more confined to the lung and respiratory system without triggering the massive endothelial cell activation leading to the pronounced clotting.

    We should know pretty soon.
    FL

  2. brightlight 3 juli 2020 12:50
    quote:

    Flatlander schreef op 2 juli 2020 20:55:


    [...]

    BL

    Do you have a figure as to how much headcount has been added to G&A functions in the last year? Some of the increased costs reflect finance costs for the convertible. Also, I suspect that some of the G&A costs are associated with 50% of the costs for setting up the operations in Hong Kong.

    FL



    FL
    Let me start with what I do know for certain: staffing in the US amounts to 20 persons (more or less) (interview Verrelst for VFB). That would be mainly sales and sales support. It surprises me that it is such a small team for such a large market.
    Concerning WondfoCartis, I don't think that staff shows up in the overall books. WondfoCartis would keep separate books, since it is a joint venture. So you will only see WondfoCartis in the Biocartis books as "investment" on the one hand and "a revenue-stream coming back (including cartridge and system sales)" which will be booked together with all the other revenue, I suspect..
    Concerning the headcount added to G&A, and other depts, I compiled this spreadsheet a couple of months ago. Do not quite remember where I got all the figures from, the annual reports, I suspect. I do not vouch for 100% correctness, so take it with a grain of salt. Do note that the cost per person per year often goes up significantly, Why? Another mystery to be added to the list. Cost control would certainly help in so many areas, it seems. Also note that G&A headcount has grown the most while it is pure overhead. I do not like that.
    BL
  3. brightlight 3 juli 2020 14:34
    FL
    Thanks for the long explanation on the Covid triage study. I understand what you are saying, but I am not up to speed concerning who exactly is doing this study. ImmunExpress?
    Anyway, the way I understand it, Septicyte Rapid would be the ideal test to determine if a particular patient's immune system reaction to Covid19 leads to blood clotting (or not)? Do I understand it correctly that the Covid 19 test under development by Bcart is needed to first determine if a patient has Covid 19 (or not)? I wonder why both tests need to be used in combination. Why can't a doctor decide to do the Rapid test immediately when he sees that the patient has respiratory problems? Why did Bcart put all the time and effort into developing the Bcart Covid test, while meanwhile there are no doubt many other Covid tests on the market that do the job equally good or equally fast? I just wonder what is the added value. Please explain.
    BL
  4. Flatlander 3 juli 2020 17:02
    quote:

    brightlight schreef op 3 juli 2020 12:50:


    [...]
    FL
    Let me start with what I do know for certain: staffing in the US amounts to 20 persons (more or less) (interview Verrelst for VFB). That would be mainly sales and sales support. It surprises me that it is such a small team for such a large market.
    Concerning WondfoCartis, I don't think that staff shows up in the overall books. WondfoCartis would keep separate books, since it is a joint venture. So you will only see WondfoCartis in the Biocartis books as "investment" on the one hand and "a revenue-stream coming back (including cartridge and system sales)" which will be booked together with all the other revenue, I suspect..
    Concerning the headcount added to G&A, and other depts, I compiled this spreadsheet a couple of months ago. Do not quite remember where I got all the figures from, the annual reports, I suspect. I do not vouch for 100% correctness, so take it with a grain of salt. Do note that the cost per person per year often goes up significantly, Why? Another mystery to be added to the list. Cost control would certainly help in so many areas, it seems. Also note that G&A headcount has grown the most while it is pure overhead. I do not like that.
    BL


    BL

    If your numbers are correct, I agree G&A expansion in 2019 is out of wack as a proportion and ops growth was very low. Although, from the 2020 job listings I have seen thus far this year I think they have been targeted mostly toward S&M, Ops and R&D. So it makes some sense that higher level planning function hiring might occur prior to the growth in the other areas. So I'd say that the 20 person increase somewhat depends on the specific persons. I'm sure the financing requires a few people for compliance purposes, An increase in HR before a major hiring expansion makes sense.
    I wonder if some of the hires were brought in initially under G&A to to build a department and will later be shifted to a profit center or another function. I hope the increase $/employee does not reflect hiring difficulties. It may, it seems like EU companies may emphasize more pay up front than stock option compensation.

    Long story short, you might need to average your numbers over a 3 year period or so to see if things look more reasonable.

    FL

  5. Flatlander 3 juli 2020 17:03
    quote:

    brightlight schreef op 3 juli 2020 14:34:


    FL
    Thanks for the long explanation on the Covid triage study. I understand what you are saying, but I am not up to speed concerning who exactly is doing this study. ImmunExpress?
    Anyway, the way I understand it, Septicyte Rapid would be the ideal test to determine if a particular patient's immune system reaction to Covid19 leads to blood clotting (or not)? Do I understand it correctly that the Covid 19 test under development by Bcart is needed to first determine if a patient has Covid 19 (or not)? I wonder why both tests need to be used in combination. Why can't a doctor decide to do the Rapid test immediately when he sees that the patient has respiratory problems? Why did Bcart put all the time and effort into developing the Bcart Covid test, while meanwhile there are no doubt many other Covid tests on the market that do the job equally good or equally fast? I just wonder what is the added value. Please explain.
    BL
  6. Flatlander 3 juli 2020 18:35
    brightlight schreef op 3 juli 2020 14:34:

    FL
    Thanks for the long explanation on the Covid triage study. I understand what you are saying, but I am not up to speed concerning who exactly is doing this study. ImmunExpress?
    Anyway, the way I understand it, Septicyte Rapid would be the ideal test to determine if a particular patient's immune system reaction to Covid19 leads to blood clotting (or not)? Do I understand it correctly that the Covid 19 test under development by Bcart is needed to first determine if a patient has Covid 19 (or not)? I wonder why both tests need to be used in combination. Why can't a doctor decide to do the Rapid test immediately when he sees that the patient has respiratory problems? Why did Bcart put all the time and effort into developing the Bcart Covid test, while meanwhile there are no doubt many other Covid tests on the market that do the job equally good or equally fast? I just wonder what is the added value. Please explain.
    BL


    BL
    I lost a long explanation into cyberspace when I took a phone call and then tried to edit the response and it timed out.

    I went into the long explanation since I see the founders of Inflammatix taking shots at Immunexpress. As far as I know Septicyte and Host Dx (the Inflammatix test) are the only immune system response Sepsis tests on the market. Both were 4-6 hr lab based tests. I think these Host Immune system response based tests will become state of the art in diagnosis of Sepsis. Inflammatix is trying to get there test on a POC system that will allow 1 hr TAT. They are promising it in 2021. Thus ImmunExpress may only have a 6 month to 1 year head start. However, in a pandemic that could be hundreds of thousands of lives.

    The Idylla COVID test development should not have been costly. Cepheid did the same thing to repurpose a cartridge for COVID and they got the FDA EUA within two months of announcing the intent to develop such a test. So I think it is reasonable to expect the Idylla COVID cartridge to get FDA and EU EUA later in July or early August. I think there is a lot of room in the market for a fast TAT COVID test. Cepheid provides answers in about 45 mins and is reported to be about 98% accurate. The Abbot Alere ID-Now system is reported to have about a 15% false negative rate, so the 10 to 15 min TAT may not matter. I think Panther also has a fast TAT POC device.

    The images out of the worlds largest medical complex in Houston Texas this week are bleak. Dr's are having to determine which patients get access to the ICU and which do not. Immunexpress/Idylla will enable identification of which patients are likely to develop the deadly immune system response that leads to clotting and death from the ones that have pneumonia like breathing difficulties which are not showing signs of developing the clotting/sepsis chain reaction that leads to death.

    Combining Septicyte Rapid with a Covid test makes a lot of sense, since Septicyte Rapid says nothing about the pathogen that is at the root of the body's immune system over-reaction. I think offering COVID testing on the Idylla platform gives the ERs an extra reason to purchase the system since it will ID not just the potential for sepsis but also whether the most likely pathogen circulating throughout the population is at the root of the immune response.

    FL
  7. Flatlander 4 juli 2020 00:08
    One final point on Septicyte Rapid

    To be considered a successful validation, Septicyte Rapid will need to outperform c-reactive protein (CRP) in identifying sepsis. The attached Lancet article suggests that the cut-off is about 0.73 AUC. Because COVID seems to generate such a strong host response reflected by the massive clotting documented in the autopsies, I think a strong Septicyte response is probable.
    FL
    www.thelancet.com/journals/eclinm/art...
  8. brightlight 4 juli 2020 13:15
    quote:

    Flatlander schreef op 3 juli 2020 18:35:


    BL
    Inflammatix is trying to get there test on a POC system that will allow 1 hr TAT. They are promising it in 2021.

    So I think it is reasonable to expect the Idylla COVID cartridge to get FDA and EU EUA later in July or early August.
    FL

    FL
    Thanks for the in-depth explanation. Hugely interesting and informative as always. Two remarks:
    - because of the Inflammatix competition breathing down ImmunExpress' neck, the Bcart/ImmunExpress tandem appears to be the perfect combination. Finally there is a killer app (or so it seems) in the Bcart arsenal for which all noses are pointing in the same direction. This cannot be said about the Bcart/Exas combination, unfortunately (or so it seems).
    - I doubt the Covid test will be approved so soon. Nothing is ever on time at Bcart and they haven't yet communicated that the development of the test has been completed. I would expect a press release on that first.
    Many good things appear to be in the making at Bcart. However, investors are clearly waiting for the first signs that all of this is being translated into sales. Unless there comes a shock positive press release of some sort, I believe the share price will continue trending lower for the time being. To be entirely honest, I feel we should see growth of at least 50 to 60% in 2021 and beyond to offset the ballooning costs. In view of the fact that the installed base is still peanuts in comparison to the market potential, and in view of the fact that Bcart salesforce is now being complemented by the Nichirei, WondfoCartis and ImmunExpress salesforces, this should entirely be possible. Also as you stressed many times before, full approval for the tests in the States and China will be a major inflection point. I wish we would get better status updates on the approval-process in China. Let's wait and see.
    BL
  9. Flatlander 4 juli 2020 18:38
    quote:

    brightlight schreef op 4 juli 2020 13:15:


    [...]
    FL
    ...Bcart/ImmunExpress tandem appears to be the perfect combination. Finally there is a killer app (or so it seems) in the Bcart arsenal for which all noses are pointing in the same direction. This cannot be said about the Bcart/Exas combination, unfortunately (or so it seems).
    - I doubt the Covid test will be approved so soon. Nothing is ever on time at Bcart and they haven't yet communicated that the development of the test has been completed. I would expect a press release on that first.

    Many good things appear to be in the making at Bcart. However, investors are clearly waiting for the first signs that all of this is being translated into sales. Unless there comes a shock positive press release of some sort, I believe the share price will continue trending lower for the time being. To be entirely honest, I feel we should see growth of at least 50 to 60% in 2021 and beyond to offset the ballooning costs. In view of the fact that the installed base is still peanuts in comparison to the market potential, and in view of the fact that Bcart salesforce is now being complemented by the Nichirei, WondfoCartis and ImmunExpress salesforces, this should entirely be possible. Also as you stressed many times before, full approval for the tests in the States and China will be a major inflection point. I wish we would get better status updates on the approval-process in China. Let's wait and see.
    BL



    The EXAS situation is likely an extended cost benefit analysis on their part. They are getting considerable heat about when they will turn all the growth into profitability. I think they want to see more traction on Idylla console deployment. But even if they decided to expand the physical lab network, they will have considerable cost. It probably depends on the new upcoming tests that they want to launch. If cologuard, liverguard ,,,, will require physical labs, they may be considering whether they are better off going that route sooner rather than later. On the other hand IVD launch on Idylla is probably attractive in the Emerging Markets where volumes might not be high enough to support a physical lab facility. I think they are weighing a lot of pros and cons. If BCART expands the Idylla console base it would make the entire platform that much more attractive to EXAS as a partner. The launch of EGFR and MSI with strong CDx growth driven by AZN and BMS sales forces could really help turn the tide and make EXAS decision much easier. I suspect the EU is starting to return to more normal testing numbers. So maybe we hear something about the AZN validation studies in the near future.

    With regard to the COVID test, I don't think you will get an announcement from BCART when it is developed and when they file for EU and FDA approval. I don't think the hurdle is that high and the FDA is announcing several EUA approvals per week (mostly lab based). The Septicyte Rapid validation if successful for COVID Triage will be highly touted. From what I can see Immune Express has not staffed up that much for the Septicyte Rapid Launch. They are privately held so the info is sketchy, but it looks like less than 50 employees, up from 14 a couple years ago. It is possible that their investors JnJ, & Debiopharm..... may assist with the launch. As I said before, Septicyte rapid could lead to a quick acceleration of the number of consoles but they will likely be used in the ER and may not initially be placed in proximity to the oncology users. So the cross sales opportunities for oncology MDx products may be limited.

    We'll know much more on a lot of these fronts in the coming months.

    Regards FL


  10. brightlight 4 juli 2020 19:26
    FL
    Indeed, as far as I can see, things are as normal as can be in Europe, under the circumstances. In Belgium, rigorous measures are still being taking in shops and companies as far as wearing masks, social distancing, etc. is concerned, although it could still be handled better in supermarkets, I feel. The great surge of Covid patients in hospitals seems to be over for a while already, so I suspect it is mostly business as usual as far as all other wards are concerned. It has been reported that there is a shortage of certain kinds of medicine, though. Have a nice weekend!
    BL
  11. Flatlander 5 juli 2020 16:37
    BL
    I'm envious of places with strong science based leadership from the top. Trumps program of leaving it up to each state, county and municipality to enact their own restrictions is doomed for failure. Meanwhile Draft Dodging Donny is holding indoor rallies with no masks or distancing, He has turned the only available preventative measures into a political statement of stupidity. He goes to his rallies and touts that the economy is coming back. Anyone can recognize that there can be no sustained recovery without getting the virus under control. I am convinced that this pandemic management is another way that Putin's control over Trump continues to exact a huge price. The US stock market is held up by the $1.6 trillion that the Fed printed and moved to the Treasury's balance sheet Steve Minuchin will undoubtedly shovel the money into the economy in the remaining 4 months leading up to the election. in hopes of placating the dumb masses. I fear for this fall and winter in the USA. Good time to be investing abroad.

    Don't think this is long seated bias. I'm independent and have voted Republican as often as Democratic. Facts are just facts and cant be overlooked. .Another weekend and another political rant!

    FL
  12. Gijpie 5 juli 2020 17:18
    FL I can understand the doubt about this clown you call president but you must admitt he does everything which he said he was going to do . Unlike politicians over here who do not remember what they have promised the day after they got elected. In fact we are a small country of about 11 miljoen an we have more politicians than the whole US of A and of course the highest tax rate of the whole world. So if you are depressed about things it can always be worse try living in Belgium, grtz
  13. brightlight 6 juli 2020 10:01
    quote:

    Flatlander schreef op 5 juli 2020 16:37:


    BL
    I'm envious of places with strong science based leadership from the top. Trumps program of leaving it up to each state, county and municipality to enact their own restrictions is doomed for failure. Meanwhile Draft Dodging Donny is holding indoor rallies with no masks or distancing, He has turned the only available preventative measures into a political statement of stupidity. He goes to his rallies and touts that the economy is coming back. Anyone can recognize that there can be no sustained recovery without getting the virus under control. I am convinced that this pandemic management is another way that Putin's control over Trump continues to exact a huge price. The US stock market is held up by the $1.6 trillion that the Fed printed and moved to the Treasury's balance sheet Steve Minuchin will undoubtedly shovel the money into the economy in the remaining 4 months leading up to the election. in hopes of placating the dumb masses. I fear for this fall and winter in the USA. Good time to be investing abroad.

    Don't think this is long seated bias. I'm independent and have voted Republican as often as Democratic. Facts are just facts and cant be overlooked. .Another weekend and another political rant!

    FL

    FL
    Agree completely. the only thing he has done is lining his own pockets, those of his fellow millionaires (the tax cut remember), those of the military; dividing the country, bashing women, the press and minorities, not revealing his tax return as he promised a zillion times during election, fire members of his staff incessantly, support the gun lobby, put pressure on the Fed, although it is supposed to be independent, barely finished one third of the wall he has promised, put many American small companies on the brink of bankruptcy with his trade war, his handling of the pandemic, destroy relationships with virtually every other country in the world, play golf during office hours, act like a spoiled brat on twitter, etc., etc. I am sure you can add a few more, because you follow the news more closely. So the question is, what has he done for the good of the country?
    BL
  14. Flatlander 6 juli 2020 15:01
    quote:

    brightlight schreef op 6 juli 2020 10:01:


    [...]
    FL
    Agree completely. the only thing he has done is lining his own pockets, those of his fellow millionaires (the tax cut remember), those of the military; dividing the country, bashing women, the press and minorities, not revealing his tax return as he promised a zillion times during election, fire members of his staff incessantly, support the gun lobby, put pressure on the Fed, although it is supposed to be independent, barely finished one third of the wall he has promised, put many American small companies on the brink of bankruptcy with his trade war, his handling of the pandemic, destroy relationships with virtually every other country in the world, play golf during office hours, act like a spoiled brat on twitter, etc., etc. I am sure you can add a few more, because you follow the news more closely. So the question is, what has he done for the good of the country?
    BL


    BL I'll try to give you an answer and then refrain from future political discussions. Trump would point to the following as his administrations accomplishments:

    1) Appointment of 2 conservative Supreme court justices and nearly 200 at the Appellate and District court levels;
    2) He claims 2016 -2019 were the best economy ever;
    3) He claims that that he has eliminated unnecessary impediments in the government;
    4) He claims he is on the brink of China trade concessions that his predecessors were too weak to pursue;
    5) He claims that he has restricted the flow of illegal immigrants that were steeling jobs from hard working Americans.
    6) Lets not forget the 2018 Tax cut that never generated the increased growth that was supposed to pay for it.

    Truth is he has dismantled a lot of necessary elements of government. The EPA has been replaced by pro-coal and chemical industry representatives; The State department has lost a generation of ambassadors, policy makers,intelligence people, etc to the detriment of our relations abroad. In 2018 he had John Bolton disband the pandemic response team that Obama created after the Ebola near miss (what a well timed one that was). Truth is China has benefited from his actions. He ceded the US claim to any portion of the clean environment economy, we have ceded any political influence in emerging markets (Africa, South America, etc) to the Chinese. The truth is that the economy during his tenure has largely followed the same trajectory it was on under Obama.

    There is a certain element of my country (about 38%) that feel threatened by changing economic and social conditions. Trump was really successful recognizing this discord and tapping into it. Likely with the help of Putin.

    The US mishandling of this pandemic will mark a reset for the U.S. economy (and not in a good way). We are on a liquidity high that will wear off in the coming months. Failure to contain the virus to levels that can be traced and dealt with will be a huge drag on the economy. A while back you did a comparison of key ratios for several MDx companies. If you revisit that analysis you will see that the US based company PS, PB, PE's (where applicable) are getting stretched. I think a reckoning will come later this year that this premium is not justified. I think we may well see pronounced dollar weakening next year.

    I love my country and 'm certain we will exit this chapter and will become stronger in the future. Our founding father's built a system with numerous checks and balances on power. They never contemplated that one of the branches of government would be complicit by not not executing on their constitutionally mandated duties. If the Polls are to be believed, the majority recognize these failures and we will be voting in a new president and senate majority this November.

    Hopefully the news flow picks up at BCART so I don't head down this road again.

    FL
  15. Flatlander 9 juli 2020 20:39
    ImmunExpress and Novacyt/Primerdesign have a 4 yr relationship to develop other sepsis assays. I think it is likely that the collaboration should start to bear fruit soon since the relationship was recently expanded. Given that most of Inflamatix work on HostDx occurred after ImmunExpress pointed the way with Septicyte Lab, I think it is fair bet that very little information on this programs progress will leak out. I also think it is a pretty fair bet that some of these assays might eventually launch on Idylla (due to the need for rapid POC decision making).

    FL
    novacyt.com/wp-content/uploads/2019/0...

  16. Grijze 17 juli 2020 15:12
    Mechelen, Belgium, 23 April 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the development of a SARS-CoV-2 test, the virus that causes COVID-19, on the fully automated, rapid and easy to use molecular diagnostics platform IdyllaTM.
    Upon regulatory approval, the IdyllaTM SARS-CoV-2 test is targeted to help healthcare providers manage the COVID- 19 pandemic through rapid and easy testing of individuals with flu-like symptoms.

    De uitslag van andere testen laat 24 tot 48 uur op zich wachten.
    Als het zo belangrijk is om snel resultaten van geteste personen te kennen, met het oog op het indijken van het virus, waarom wordt deze test dan niet ingezet bij de contact tracing.
    Afgaande op de laatste cijfers is enige urgentie hier wel gepast dacht ik zo.

    Grijze
  17. joe123 17 juli 2020 16:16
    quote:

    Grijze schreef op 17 juli 2020 15:12:


    Mechelen, Belgium, 23 April 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the development of a SARS-CoV-2 test, the virus that causes COVID-19, on the fully automated, rapid and easy to use molecular diagnostics platform IdyllaTM.
    Upon regulatory approval, the IdyllaTM SARS-CoV-2 test is targeted to help healthcare providers manage the COVID- 19 pandemic through rapid and easy testing of individuals with flu-like symptoms.

    De uitslag van andere testen laat 24 tot 48 uur op zich wachten.
    Als het zo belangrijk is om snel resultaten van geteste personen te kennen, met het oog op het indijken van het virus, waarom wordt deze test dan niet ingezet bij de contact tracing.
    Afgaande op de laatste cijfers is enige urgentie hier wel gepast dacht ik zo.

    Grijze


    Niemand die het van ons weet Grijze. Het blijft vanuit Biocartis zelf ook oorverdovend stil. Begrijpe wie begrijpe kan.Hoelang is het nu al geleden dat er nog een PB buiten is gekomen.Zelfs geen verwachtingen omtrend nieuwe testen.Ben zoals al zoveel jaren benieuwd naar de kwartaalcijfers.Stel je voor dat ze ons eens postief gaan verassen.
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