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  1. brightlight 17 januari 2020 20:10
    quote:

    Reply schreef op 17 januari 2020 11:05:


    [...]

    Het zal daarbij vanzelfsprekend allemaal stapsgewijs gaan waarbij, zoals door meerderen hier op het forum aangegeven, de nadruk vooral zal liggen op de ontwikkelingen in de tweede jaarhelft van 2020.

    De hatelijke € 5 regionen lijken nu in elk geval tot het verleden te behoren.

    Forza Biocartis! ;-)

    Volgens mij wordt Japan de grote groeimotor voor Bcart dit jaar. Ik denk dus niet dat we tot H2 moeten wachten om positief verrast te worden. De eerste tekenen van deze Japanse groei zullen we mogelijk reeds kunnen waarnemen op 5 maart bij de bekendmaking van de guidance voor 2020. Als mijn redenering in mijn post van 16 jan 2020 om 18:44 klopt, dan kunnen we dit jaar, zelfs als slechts 200 van de 2000 Japanse klanten van Nichirei besluiten een Idylla aan te schaffen, een zeer mooie groei tegemoet zien. Bcart verstrekt ons helaas onvoldoende concrete cijfers om aan mijn inschatting een grotere zekerheid te koppelen.
    BL
  2. brightlight 17 januari 2020 20:13
    quote:

    DRTVR schreef op 17 januari 2020 20:03:


    Ben maar een leek, dus als ik het goed begrijp, als men NGS toepast heeft men Idylla niet meer nodig?

    Als men tussen de 100.000 en het miljoen Euro voor de aanschaf van zo'n toestel over heeft en een heel leger analisten om de data te interpreteren.
    BL
  3. D.vdB 17 januari 2020 20:26
    quote:

    DRTVR schreef op 17 januari 2020 20:03:


    Ben maar een leek, dus als ik het goed begrijp, als men NGS toepast heeft men Idylla niet meer nodig?

    Nee, zeker niet. Idylla is een op qPCR gebaseerd systeem. NGS is een andere methodiek voor medical diagnostics.

    Op pagina 7 van de bedrijfspresentatie zie je welke systemen er bestaan (NGS, PCR, Sanger sequencing, ea.).
    investors.biocartis.com/en/corporate-...

  4. forum rang 6 Reply 17 januari 2020 20:31
    quote:

    brightlight schreef op 17 januari 2020 20:10:


    [...]
    Volgens mij wordt Japan de grote groeimotor voor Bcart dit jaar. Ik denk dus niet dat we tot H2 moeten wachten om positief verrast te worden. De eerste tekenen van deze Japanse groei zullen we mogelijk reeds kunnen waarnemen op 5 maart bij de bekendmaking van de guidance voor 2020. Als mijn redenering in mijn post van 16 jan 2020 om 18:44 klopt, dan kunnen we dit jaar, zelfs als slechts 200 van de 2000 Japanse klanten van Nichirei besluiten een Idylla aan te schaffen, een zeer mooie groei tegemoet zien. Bcart verstrekt ons helaas onvoldoende concrete cijfers om aan mijn inschatting een grotere zekerheid te koppelen.
    BL


    Op 5 maart met de officiële jaarcijfers 2019 verwacht ik zelf eerlijk gezegd minder spektakel, maar laat mijzelf natuurlijk ook graag positief verrassen ;-)

    Waarom dan minder spektakel? Feitelijk zijn de cijfers met de update van 9 Januari ondertussen bekend en zullen de uiteindelijke, door de accountant gecontroleerde, cijfers dan ook slechts marginaal verschillen.
    En wat betreft de guidance voor 2020 heeft Biocartis natuurlijk een harde les geleerd in 2019 en zal nu naar mijn verwachting eerder relatief voorzichtig zijn in hun guidance voor 2020.
    Beter en veiliger is het dan om mogelijk van kwartaal op kwartaal positief te gaan verrassen in 2020.
    Met het recente jaar 2019 in gedachten zou ik hen deze strategie ook geheel niet kwalijk nemen.
  5. brightlight 17 januari 2020 21:35
    quote:

    Reply schreef op 17 januari 2020 20:31:


    [...]

    Op 5 maart met de officiële jaarcijfers 2019 verwacht ik zelf eerlijk gezegd minder spektakel, maar laat mijzelf natuurlijk ook graag positief verrassen ;-)

    Waarom dan minder spektakel? Feitelijk zijn de cijfers met de update van 9 Januari ondertussen bekend en zullen de uiteindelijke, door de accountant gecontroleerde, cijfers dan ook slechts marginaal verschillen.
    En wat betreft de guidance voor 2020 heeft Biocartis natuurlijk een harde les geleerd in 2019 en zal nu naar mijn verwachting eerder relatief voorzichtig zijn in hun guidance voor 2020.
    Beter en veiliger is het dan om mogelijk van kwartaal op kwartaal positief te gaan verrassen in 2020.
    Met het recente jaar 2019 in gedachten zou ik hen deze strategie ook geheel niet kwalijk nemen.

    Ik ben ook van mening dat ze een voorzichtige guidance zullen geven, maar zelfs met een voorzichtige guidance (in hun ogen) kunnen ze nog positief verrassen (in de ogen van de markt). Japan is de sleutel.
    BL
  6. forum rang 6 Reply 17 januari 2020 21:50
    quote:

    brightlight schreef op 17 januari 2020 21:35:


    [...]
    Ik ben ook van mening dat ze een voorzichtige guidance zullen geven, maar zelfs met een voorzichtige guidance (in hun ogen) kunnen ze nog positief verrassen (in de ogen van de markt). Japan is de sleutel.
    BL


    Ik begrijp wat je zegt maar kijk zelf vooral uit naar Donderdag 23 April met de eerste harde feiten van 2020 middels de 1e kwartaalcijfers 2020.
  7. forum rang 4 Flatlander 18 januari 2020 00:26
    BL

    We definitely are not in agreement on this issue. I think Idylla is currently finding its market niche in a landscape where NGS is dominating work flow and the press clippings. That is part of the reason the Journal of Clinical Pathology is flow charting ways in which Idylla may be incorporated into the work flow in a manner that compliments the strength of NGS methods.

    jcp.bmj.com/content/71/9/757

    That said, bells and whistles like whole genome mapping are sexy, but when it comes right down to it I think the market will focus on fast, low cost answers to questions like will this woman with breast cancer benefit from chemotherapy or not? As long as BCART focuses on assays with actionable results I think there is a very lucrative place for them in the market.

    Have a great weekend.

    FL
  8. forum rang 4 Flatlander 18 januari 2020 00:56
    Here is the quote I was referring to. I'll start using the boards quote feature

    "There are quite a few posts about NGS lately. I think we should frame this, for those investors who don't want to dig this deep into the technical side, that we are talking about something that might (or might not) become a problem for Bcart in five years time or later. By that time Bcart will have evolved too, and rest assured that Bcart is monitoring NGS and other cutting edge technologies closely."
    BL



    BL

    We definitely are not in agreement on this issue. I think Idylla is currently finding its market niche in a landscape where NGS is dominating work flow and the press clippings. That is part of the reason the Journal of Clinical Pathology is flow charting ways in which Idylla may be incorporated into the work flow in a manner that compliments the strength of NGS methods.

    jcp.bmj.com/content/71/9/757

    That said, bells and whistles like whole genome mapping are sexy, but when it comes right down to it I think the market will focus on fast, low cost answers to questions like will this woman with breast cancer benefit from chemotherapy or not? As long as BCART focuses on assays with actionable results I think there is a very lucrative place for them in the market.

    Have a great weekend.

    FL
  9. Gijpie 18 januari 2020 06:37
    Ik denk toch ook da in de korte termijn Japan de sleutel is zeker om het aantal idylla’s fors te kunnen opdrijven . We hebben kunnen zien in het laatste kwartaal dat als het aantal idylla’s groter word dit een significante impact kan hebben op het cartridge volume . In Amerika spelen andere krachten denk ik met een sterk gepolitiseerde FDA zal het daar van de partners afhangen denk ik hoe snel er market acceptance komt . Ik zou ook heel graag wa nieuws zien uit het Wonfo kamp da heeft toch al een pak geld gekost en als ge spreekt van ne markt China is er wel enen da zou nen enorme trigger kunnen zijn naar de beurskoers toe
  10. forum rang 4 Flatlander 18 januari 2020 19:54
    quote:

    brightlight schreef op 17 januari 2020 19:49:


    There are quite a few posts about NGS lately. I think we should frame this, for those investors who don't want to dig this deep into the technical side, that we are talking about something that might (or might not) become a problem for Bcart in five years time or later. By that time Bcart will have evolved too, and rest assured that Bcart is monitoring NGS and other cutting edge technologies closely.
    BL


    This article describes how the current international standard for EGFR Lung molecular pathology analysis is currently NGS methods. However, in approximately 37% of these NGS analyses invalid/unactionable results are obtained. Hetrogeneity, small sample size, etc can eaffect the NGS results. Idylla can be used to obtain actionable results in most of these cases.


    www.abacusdx.com/media/jclinpath-2018...
  11. forum rang 4 Flatlander 18 januari 2020 20:19
    Based on the last couple posts, I believe that Idylla niche is smaller pathology labs and clinical settings and as a rescue analysis in larger labs where valid NGS results cannot be obtained. This is still a great potential market. Idylla is limited to about 4 or 5 analyses per console unit per day. Even the 8 unit models would be limited to 30 to 40 samples per day. For this reason large high throughput large labs are likely to employ Idylla as a first line mDx analysis method. Their use is likely to be limited to reducing the number of non congruent NGS results.

    there are a number of great marketing angles once Idylla is approved for diagnostic use.
    FL

    FL
  12. forum rang 4 Flatlander 18 januari 2020 23:47
    While current diagnostic protocols for lung cancer, show a preference for NGS methods, the author proposes that Idylla be used to rescue the relatively large number of NGS failures. Here are the insights from the previously referenced publication addressing NGS use vs Idylla.

    Discussion
    This study data, besides confirming that NGS and Idylla are
    both accurate to detect EGFR activating mutations, show that
    the Idylla system is a viable option for rapid genotyping in NGS
    ‘invalid’ cases. Although updated international guidelines represent the scientific
    backbone for lung cancer biomarker testing, they do not necessarily
    reflect real-world routine practice, as local issues require
    local solutions.10 Indeed, the standard of practice in large and
    comprehensive cancer treatment centres is far different from that of
    less specialised settings. The very recent revised guidelines from
    the College of American Pathologists, the International Association
    for the Study of Lung Cancer, and the Association for Molecular
    Pathology recommend that NGS panels should be preferred over
    single gene tests. Indeed, beyond EGFR also the BRAF, ERBB2
    (HER2), KRAS and MET mutational status may be assessed by
    DNA-based NGS assays. Moreover, compared with sequential
    single gene testing NGS may be useful to spare clinical samples,
    whose abundance in neoplastic component is often limited, and, in
    clinical terms, to help patients find appropriate clinical trials.
    However, while technology is advancing at a rapid pace and
    several DNA/RNA-based high-throughput technological solutions
    are emerging, currently NGS assays are often still limited to
    DNA alterations detection only, while most testing laboratories
    still strongly rely on immunohistochemical or fluorescent in situ
    hybridisation assays to detect ALK and ROS1 alterations. Thus,
    single gene testing methods are still acceptable to detect EGFR
    mutations provided that the recommended 10 working days’
    TAT is met. In this setting, the timely communication between
    oncologists and molecular pathologists is crucial, in particular
    for acute deteriorating patient clinical management. Our data
    showed that, when clinical decisions should be taken quickly and
    when saving time is a crucial issue, since days have been spent
    for an ‘invalid’ NGS result, Idylla can provide a solution. As a
    general rule, regardless of the sample type, we directly pipetted
    in the cartridge from 3 up to 10 µL of extracted DNA preparation.
    Indeed, in this study, Idylla ‘rescued’ a large portion of
    cases (20/25; 80%) whose preliminary assessment by NGS was
    unfeasible (figure 4). Therefore, we propose an algorithm that
    could be used for clinical determination of EGFR mutational
    status Idylla, thanks to its capability of using only one FFPE slice
    Figure 3 Case 63. Evaluation of DNA quality and quantity relative by a microfluidic platform based on electrophoretic system (4200 TapeStation,
    Agilent). The electrophoretic profile features highly fragmented DNA. The poor DNA integrity number (DIN value 1.1) explained how this case failed
    both when processed by next generation sequencing (NGS) and by Idylla. FU, fluorecence unit.
    J Clin Pathol: first published as 10.1136/jclinpath-2018-205197 on 24 May 2018. Downloaded from jcp.bmj.com/ on 7 June 2018 by guest. Protected by copyright.

    Discussion
    This study data, besides confirming that NGS and Idylla are
    both accurate to detect EGFR activating mutations, show that
    the Idylla system is a viable option for rapid genotyping in NGS
    ‘invalid’ cases.
    Although updated international guidelines represent the scientific
    backbone for lung cancer biomarker testing, they do not necessarily
    reflect real-world routine practice, as local issues require
    local solutions.10 Indeed, the standard of practice in large and
    comprehensive cancer treatment centres is far different from that of
    less specialised settings.10 The very recent revised guidelines from
    the College of American Pathologists, the International Association
    for the Study of Lung Cancer, and the Association for Molecular
    Pathology recommend that NGS panels should be preferred over
    single gene tests.11 Indeed, beyond EGFR also the BRAF, ERBB2
    (HER2), KRAS and MET mutational status may be assessed by
    DNA-based NGS assays. Moreover, compared with sequential
    single gene testing NGS may be useful to spare clinical samples,
    whose abundance in neoplastic component is often limited, and, in
    clinical terms, to help patients find appropriate clinical trials.
    However, while technology is advancing at a rapid pace and
    several DNA/RNA-based high-throughput technological solutions
    are emerging, currently NGS assays are often still limited to
    DNA alterations detection only, while most testing laboratories
    still strongly rely on immunohistochemical or fluorescent in situ
    hybridisation assays to detect ALK and ROS1 alterations.12 Thus,
    single gene testing methods are still acceptable to detect EGFR
    mutations provided that the recommended 10 working days’
    TAT is met.11 In this setting, the timely communication between
    oncologists and molecular pathologists is crucial, in particular
    for acute deteriorating patient clinical management.5 Our data
    showed that, when clinical decisions should be taken quickly and
    when saving time is a crucial issue, since days have been spent
    for an ‘invalid’ NGS result, Idylla can provide a solution. As a
    general rule, regardless of the sample type, we directly pipetted
    in the cartridge from 3 up to 10 µL of extracted DNA preparation.
    4 Indeed, in this study, Idylla ‘rescued’ a large portion of
    cases (20/25; 80%) whose preliminary assessment by NGS was
    unfeasible (figure 4). Therefore, we propose an algorithm that
    could be used for clinical determination of EGFR mutational
    status Idylla, thanks to its capability of using only one FFPE slice
    Figure 3 Case 63. Evaluation of DNA quality and quantity relative by a microfluidic platform based on electrophoretic system (4200 TapeStation,
    Agilent). The electrophoretic profile features highly fragmented DNA. The poor DNA integrity number (DIN value 1.1) explained how this case failed
    both when processed by next generation sequencing (NGS) and by Idylla. FU, fluorecence unit.
    J Clin Pathol: first published as 10.1136/jclinpath-2018-205197 on 24 May 2018. Downloaded from jcp.bmj.com/ on 7 June 2018 by guest. Protected by copyright.
  13. brightlight 20 januari 2020 13:58
    FL, thanks for providing us with this elaborate update on the state of affairs concerning NGS and the ways in which Bcart can benefit from NGS's shortcomings. Concerning Bcart, judging from the recent price action, it seems to me the market is slowly waking up to the fact that Bcart has an enormous growth potential on offer at a very fair share-price. A rarity in these markets.
    BL
  14. forum rang 4 Flatlander 20 januari 2020 15:15
    BL
    As we have discussed in the past, the current valuation metrics relative to its MDx peers certainly would justify closing the S.P. gap that developed in early September. As you have pointed out there are numerous potential catalysts that can emerge throughout the year.

    With regards to the market, the final piece necessary to unlock much wider access to the US and Japan is the final content registration/FDA approval. The following points suggest that these approvals will come:

    1) The expansive publications positively compare Idylla results to other methods;
    2) The fact that the consoles and the 1st content cartridge have already received approval;
    3) The partner clout/FDA connections.
    4) The urgent need for timely, quality, cost effective MDx data.

    The smaller hospital/clinic market would seem to be wide open since many of these facilities are only beginning to utilize MDx data for decision making. The inroads into larger pathology labs, etc will likely occur on a product by product basis, OncoTypeDx breast could quickly gain acceptance on the basis of the TailorX study. Although it is unclear how long the assay will be run in a lab in the U.S.
    The lung cancer guidance from the College of American Pathologists, the International Association
    for the Study of Lung Cancer, and the Association for Molecular Pathology favors NGS. However, even in this market a huge niche exists since more than a third of the NGS assays provide inconclusive results. In 80% of these cases Idylla has been able to take the original sample used in the NGS assay and recover actionable results. You can bet the sales team will emphasize these studies as soon as possible.

    My point is that the sales pitch will need to be directed to each practice. The addressable market seems to be huge since relative to the competing technologies, Idylla is much more cost effective.

    FL
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