Biocartis BE0974281132

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1. Gijpie 26 juni 2020 10:30

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   Ze hebben mij precies gehoord
2. MisterBlues 26 juni 2020 10:42

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   Oh ja, toch nog een keer over het ontbreken van transparantie. In mijn ogen is dat pas in de tweede plaats vanwege de concurrentie en in de eerste plaats vanwege de beursnotering:
   
   Het verdienmodel van BCART is volledig lucide. In de kern gaat het om machines waar cassettes in passen die verkocht worden in diverse regio’s in de wereld. Als shorters precies weten waar die verkocht worden, tegen welke prijs en met welke marge, dan kunnen dit soort beleggers de klok gelijk zetten met hun shorts – en tamelijk accurate voorspellingen doen. Het aandeel is by nature erg gevoelig voor poliepen. Ik verwacht dus niet dat het op dit specifieke gebied veel beter gaat worden. Maar goed: wie ben ik? Een kleine belegger…
   
   Misschien hebben jullie wel een punt als het gaat om transparantie t.a.v. algemene bedrijfsvoering…
   
   Ik wil echter niet meer in discussies belanden op dit forum. Ik ben van de LT en af en toe een vinger aan de pols van het zorgenkindje. :)
   
3. Flatlander 26 juni 2020 13:29

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   quote:

   MisterBlues schreef op 26 juni 2020 08:49:

   [...]
   
   Dit is verheugende berichtgeving. Hier zat ik op te wachten. Dit soort uitkomsten maken het dossier compleet en een FDA goedkeuring voor de collectorale darmkankermutatie testen nabij. Ik wijs er nog even op hoe belangrijk het is om er snel bij te zijn met darmkankers omdat er altijd in een rap tempo metastasen verschijnen. (Zie ook eerdere posts van mijn hand inclusief literatuurverwijzingen.)
   
   Ik heb nog steeds hoop dat die noodzakelijke goedkeuringen komen begin 2021.
   
   Jullie?
   

   MB
   
   I woke up and saw the news and thought the same about the about the study being directed toward the FDA registration dossier. It appears aimed at the broadest approval possible. The common complaint about MDx in the U.S is that the physician has to wait for a genetics expert to interpret the report. The broad testing environment suggests that immediately actionable results were available much quicker. I'm sure BMS and Amgen helped design the study such that the results played directly into their CDx requirements.
   
   One last thought, Did any portion of the study occur at the same time as Covid ? If so, that certainly would have added to the overall average TAT of results.
   
   Good Morning
   
   FL
4. Flatlander 26 juni 2020 14:01

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   I also had the same thought that they may be a couple months ahead of the schedule they provided for the FDA PMA registration filing. This may have a broader impact such that the FDA gains appreciation for the robustness of the platform so that similar wide scale studies are not required for each future assay. I suspect the lung panel and ctEFGR will require an extensive study since there is considerable variability in the quality of the cytology/lung aspirate samples. That concern is in the future, I'll savor this mornings news.
   
   Finally, Joe I agree that the absence of a US listing is the primary reason why BCART lacks visibility in the US. This is also true of giant European companies that have no U.S. listing, or are OTC pink sheet issue. I guess listing in the U.S. before having won FDA registration approvals would have been putting the cart before the horse. Not that I want any more dilution, I think there would be visibility advantages to a US offering on the Nasdaq after receipt of FDA registration approval. I think the increased visibility and analyst coverage would drive up the S.P. more than making up for the additional shares.
   
   FL
5. Flatlander 26 juni 2020 14:09

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   Got my answer, the study ran from Nov 2017 to Dec 2018. Should have gotten into the paper before jumping on the board.
   
   FL
6. Flatlander 26 juni 2020 14:23

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   Need to retract a lot of the content of my prior posts this morning. Given the timing, it appears as is the paper was compiled from two year old data. As such I doubt that BMS and Amgen had any input into the study. I do believe it was put together in support of the filing dossier but it is likely something they simply paid Dartmouth to mine the earlier data to compile the statistics. Perhaps that is why it is having limited effect on the S.P. This statement in the PR misled me to believe this was a new study rather than a re-evaluation of existing data:
   
   "The new multicentre study included 20 laboratories of varying
   nature and size in the US and Puerto Rico, and data from nearly 800
   colorectal (colon) cancer samples. It is therefore one of the
   largest studies in which Idylla (TM) is involved. In contrast
   to other studies, often examining the turnaround time of the test
   , this study focused on the full trajectory of the sample, that is,
   the turnaround time between ordering the test and receiving the
   results, including steps such as sample transport to
   the laboratory or time taken for the pathologist to sign
   off."
   
   FL
   
   
7. RUF RTR 26 juni 2020 15:17

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   Voor mij is het nieuws een bevestiging van de suprematie van de technologie van Biocartis.
   Of die studie recent of minder recent is doet er m.i. minder toe.
   
8. Flatlander 26 juni 2020 15:29

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   Quest Diagnostics one of the two largest lab testing companies in the U.S is reporting that their testing capacity is under siege due to an increase of 50% in COVID tests in the past 3 weeks. Wish Idylla was approved to help minimize the PCR manpower needs for other Oncology MDx. Scott Gotlieb (former director of the FDA) was on CNBC yesterday urging people in the NE and Midwest US (areas where Covid peaked and declined weeks ago), to schedule any health procedures (biopsies etc) that might have been delayed during the initial wave of the pandemic.
   
   FL
   
   
9. CGCDLR 26 juni 2020 16:36

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   Ongelooflijk,schitterend nieuws,maar ik zie de koers de dag nog onder 0 eindigen!
10. MisterBlues 26 juni 2020 16:41

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    quote:

    CGCDLR schreef op 26 juni 2020 16:36:

    Ongelooflijk,schitterend nieuws,maar ik zie de koers de dag nog onder 0 eindigen!
    

    Sarcastisch? Jij gelooft er niet meer in?
11. Flatlander 26 juni 2020 17:12

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    Ruf
    
    The PR was obviously in response to Gijpie's request for more news!
    
    I'm fine with mining previous studies for news releases while pulling the information together for the FDA registration filing. It makes the value point that BCART is likely making to the FDA. However, there is a tremendous range in the Idylla TAT range 0.5 to 15 days with a mean of 5 days. It would be helpful if they underscored that these TAT times are largely a function of each institutions work flow and not Idylla technical constraints. If they chose to configure work flow around Idylla, the TATs would routinely be less than a day.
    
    FL
12. CGCDLR 26 juni 2020 17:47

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    @MisterBlues,toch wel,ik geloof er nog in.Positie is net dezelfde als op 01/012020.Met onder 0 bedoelde ik wel "in het rood"Dit hebben we kunnen vermijden,weliswaar een schrale troost.Met zo'n nieuws denk ik eerder aan bijkopen.Blijkbaar gunnen ze ons voorlopig een(m.i.)te lage koers.
13. Flatlander 29 juni 2020 00:26

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    I've previously expressed some of my conflicting views on whether Septicyte Rapid was going to be valuable in the triaging of Covid patients. The concerns arise from the early MARS study work done primarily in Amsterdam. They found that Septicyte Lab was least accurate when the sepsis arose from ARDS (Acute Respiratory Distress Syndrome). Since most of this MARS study was conducted prior to 2014 it predated COVID. Presumably the source of the pre-2014 respiratory distress was either pneumonia or flu. While COVID-19 has origins as a respiratory infection it is most problematic when it cascades into the circulatory system which starts with the response by the endothelial cells in the lungs. In these cases an aggressive host response is triggered by the damage and death of the endothelial cells. This response can lead to the cytokine storm that has been fatal for so many. This response is described in the paragraph below:
    
    www.sciencemag.org/news/2020/06/blood...
    
    "In healthy individuals, endothelial cells help regulate blood pressure, prevent inflammation, and inhibit clotting, in part through the continual production of nitric oxide (NO); they also serve as gatekeepers for molecules passing in and out of the bloodstream. When injured, they send out a complex array of signals to immune cells and clotting factors, which rush to repair the site. And they warn their fellow endothelial cells to be on alert for invaders."
    
    This response sequence triggered by COVID is not like other typical respiratory infections.
    Long story short, because in the worst cases that are likely to develop sepsis, the virus triggers a host response circulatory system inflammation/clotting mechanism, I'm more optimistic of Septicyte Rapids ability to detect biomarkers that will be of use in triaging COVID patients.
    
    However, I'm not a physician, microbiologist or a health care professional. I would welcome opinions from those with a more appropriate background. Specifically, whether the four biomarkers tracked by Septicyte are likely to be of value in triaging COVID patients likely to develop sepsis.
    
    I don't believe the market is currently factoring in much if any valuation upside associated with Septicyte Rapid. If in the next few weeks we get any positive news from the ongoing validation study that provides an answer to this question, we will likely off to the races.
    
    I'm hopeful that in the next few weeks we learn that Septicyte Rapid is a valuable tool in the fight against this pandemic.
    
    FL
14. Tryck 29 juni 2020 11:19

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    FL,
    A few days ago you wrote rather skeptical about the Exas Oncotype DX (Breast & Prostate) partnership.
    What is it exactly that makes you question the partnership, I assume there are multiple factors like delays on the timeline, the changes due to Exas merging with GHDX and limited news on the progress?
    
    In December 2018 it was announced that Genomic Health and Biocartis Expanded their Collaboration to Urology with the Development of an Idylla™ Oncotype DX Genomic Prostate Score® Test.
    
    Now, I find a recent article (16 June) where Exas published a PR in which they discuss the results of the performance of the Oncotype DX Genomic Prostate Score® (GPS™).
    
    However in this press release dated June 2020, there is no reference to Idylla or Biocartis whatsoever.
    I'm not a medical expert but as I read into the paperit seems like the GPS test shows strong results.
    
    I'm not sure why there is no reference to Biocartis or Idylla in the Exas PR so either something is going on, or Biocartis/Exas are playing this low key to stay in an underdog position.
    
    www.goldjournal.net/article/S0090-429...
    
    investor.exactsciences.com/investor-r...
    
    
15. Flatlander 29 juni 2020 14:05

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    Tryck
    There is no statement from EXAS indicating anything about the BCART partnership since last fall. I think there has been a change of heart from the top of EXAS management.since shortly after the merger. Genomic Health touted the BCART partnership during each conference call. I do hear a lot of discussion on the calls about how the acquisition of Paradigm will work to speed precision oncology TAT. Here is a section from the PR about the Acquisition of Paradigm.
    
    "Paradigm currently offers a comprehensive genomic profiling test for patients with advanced, refractory, or recurrent cancer, allowing physicians to better understand a patient's tumor profile and more effectively recommend targeted therapies or clinical trials. Palmetto GBA, a Medicare Administrative Contractor that assesses molecular diagnostic technologies under its MolDx program, recently covered the test under its existing local coverage determination for Next-Generation Sequencing for Solid Tumors. Differentiated from other tests by a design that requires smaller sample requirements and delivers faster results, the test is critical in supporting treatment decisions and builds upon the successful foundation of the Exact Sciences' Precision Oncology team."
    
    investor.exactsciences.com/investor-r...
    
    There are a few recent interviews with Kevin Conroy on the EXAS website. Listen to the parts where he discusses the ability of Paradigm to speed precision oncology. reporting. My take was that this was the primary means by which they intend to speed TAT. However, speed was not the only reason GHDX teamed with BCART. GHDX often discussed the Idylla platform as the means for addressing logistical issues associated with shipping tissue samples between countries, From what I can see this issue would still have to be worked out if EXAS choose to put all of their eggs in the NGS Paradigm platform. I could be wrong, this EU tissue shipping issue may well drive a different solution in the EU vs the U.S. Or they may be lobbying to try to get exemptions from the tissue shipping restrictions. I think they might be in the process of evaluating how paradigm might be used in the EU and ROW. They very well could still come to the decision that building out several Paradigm/EXAS lab facilities is not as cost effective as an Idylla platform. Quite possibly they are doing research discussing these issues with oncologists to determine which solution best meets their needs. The only certainty is that they have delayed the start of the Idylla validation study.
    
    FL
    
    These are all just my opinions based on the tone of conference calls and interviews.
16. Tryck 29 juni 2020 19:14

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    hey FL,
    
    Thanks for clarifying . I was not aware of this Paradigm acquisition and it indeed raises some question marks about where Exas puts its priorities (NGS / IVD) and the silence around Idylla implies this might be going into a direction which is not favorable for Biocartis .
    
    There are plenty of potential upside catalysts on the short term horizon but this one seems less positive.
    
    Kr
    Thomas
    
    
17. Flatlander 30 juni 2020 03:59

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    Thomas
    There is no direct evidence, just some reading between the lines. Perhaps an uptick in console sales due to a good Septicyte launch would make the whole platform more attractive to EXAS. I've always thought that Idylla suffered from a chicken and the egg syndrome. A Killer Ap that increases the number of consoles makes the whole platform that much more attractive to subsequent partner content launch. I thought both Oncotype DX or Septicyte has that potential. EGFR/fusion panel may also have that potential. A successful launch in China could get it done. You're correct that there are many ways to get there!
    
    FL
18. joe123 30 juni 2020 08:48

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    Biocartis krijgt fanmail van Berenberg.
    De Tijd.
19. Grobert 30 juni 2020 10:23

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    Berenberg verlaagt koersdoel van biocartis van 16,5 € naar 6,60 €.... maar.... verhoogt aanbeveling van "under review" naar "kopen"... belangrijke voortuigang de laatste jaren in moleculaire diagnose betreffende kanker + verschillende partenariaten voor samenwerking
    
    Blijkbaar geen reactie op de beurs
20. Lucid 30 juni 2020 11:04

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    quote:

    Grobert schreef op 30 juni 2020 10:23:

    Berenberg verlaagt koersdoel van biocartis van 16,5 € naar 6,60 €.... maar.... verhoogt aanbeveling van "under review" naar "kopen"... belangrijke voortuigang de laatste jaren in moleculaire diagnose betreffende kanker + verschillende partenariaten voor samenwerking
    
    Blijkbaar geen reactie op de beurs
    

    Is natuurlijk geen goed signaal als je het koersdoel zo drastisch verlaagt. Ben er zelf ook niet tevreden mee vermits mijn gemiddelde aankoopprijs rond 10 € zit, wat op zich onder hun koersdoel zat dus vermits zij de specialisten zijn zou je dan in principe op LT safe zitten. Met dit nieuwe koersdoel zeggen ze eigenlijk dat deze investering niet gaat renderen op een termijn van pakweg 1 jaar. Zeer teleurstellend dus en heermee ga je zeker geen kopers aantrekken.