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  1. forum rang 10 voda 4 mei 2021 07:06
    PERSBERICHT: Persbericht Biocartis Group NV: Biocartis kondigt nieuwe samenwerking aan met AstraZeneca om beschikbaarheid van Idylla(TM) EGFR biomarker testing bij longkankerpatiënten uit te breiden

    PERSBERICHT: 4 mei 2021, 07:00 CEST

    Biocartis kondigt nieuwe samenwerking aan met AstraZeneca om
    beschikbaarheid van Idylla(TM) EGFR biomarker testing bij
    longkankerpatiënten uit te breiden

    Ongeveer de helft van de patiënten met niet-kleincellige longkanker
    heeft tumormutaties die informatie zouden kunnen aanleveren voor een
    meer gerichte behandelingsaanpak, maar velen worden niet getest

    Mechelen, België, 4 mei 2021 -- Biocartis Group NV (de
    'Vennootschap' of 'Biocartis'), een innovatief bedrijf in de moleculaire
    diagnostiek (Euronext Brussel: BCART) kondigt vandaag aan een nieuwe
    overeenkomst te hebben getekend met AstraZeneca, een wereldwijd
    wetenschapgedreven biofarmaceutisch bedrijf (LSE/STO/Nasdaq: AZN), met
    als doel toegang te verlenen tot snelle en gebruiksvriendelijke
    Idylla(TM) EGFR testing producten op geselecteerde ziekenhuislocaties in
    de Europese en wereldwijde distributeursmarkten(1) van Biocartis ter
    ondersteuning van de identificatie van patiënten met EGFR-mutaties.

    Het nieuwe project breidt de bestaande master samenwerkingsovereenkomst
    www.globenewswire.com/Tracker?data=0X...
    (2) tussen Biocartis en AstraZeneca uit, die werd gesloten om de toegang
    tot snellere resultaten voor moleculair diagnostische biomarkers te
    bevorderen en te versterken. Het project bouwt verder op de conclusie
    van de grote prospectieve longkanker FACILITATE
    www.globenewswire.com/Tracker?data=9P...
    -studie(3) , mede gesponsord door AstraZeneca en voorgesteld in
    september vorig jaar op het gerenommeerde ESMO Virtual Congress(4) .
    Deze studie concludeerde dat Idylla(TM) EGFR testing een toegevoegde
    waarde kan bieden in een klinische setting door bruikbare EGFR-mutatie
    resultaten te genereren voor patiënten met niet-kleincellige
    longkanker (NSCLC of 'non small cell lung cancer'), sneller dan
    routinematig gebruikte methoden(5) .

    EGFR-mutaties zijn belangrijke biomarkers in NSCLC en komen voor bij
    10-15% van alle NSCLC-patiënten in de VS en de EU, en bij 30-40%
    van alle NSCLC-patiënten in Azië(6) . De volledig
    geautomatiseerde Idylla(TM) EGFR Mutation Test (
    www.globenewswire.com/Tracker?data=BT...
    CE-IVD) dekt 51 mutaties in één enkele cartridge, maakt
    gebruik van slechts één stukje FFPE(7) tumorweefsel van
    gemetastaseerd NSCLC en vertoont een hoge concordantie van >95% in
    vergelijking met referentiemethoden(8) .

    Herman Verrelst, Chief Executive Officer van Biocartis, gaf volgend
    commentaar op de overeenkomst:"AstraZeneca is voor Biocartis een
    betrouwbare businesspartner geworden en ik ben zeer verheugd om onze
    samenwerking met hen te zien rijpen en groeien. Met deze overeenkomst
    zal AstraZeneca de onboarding van nieuwe Idylla(TM) gebruikers
    vergemakkelijken en de toegang tot de Idylla(TM) EGFR Mutation Test
    (CE-IVD) verbeteren. Zo bieden we de mogelijkheid om de identificatie
    van biomarkers bij patiënten met niet-kleincellige longkanker te
    verbeteren, wat op zijn beurt kan leiden tot het beter informeren van
    tumor management teams om meer precieze patiëntmanagement
    beslissingen te nemen. Dit is belangrijk, aangezien ongeveer de helft
    van de patiënten met niet-kleincellige longkanker tumormutaties
    heeft die informatie zouden kunnen aanleveren voor een meer gerichte
    behandelingsaanpak(9) , maar velen van hen niet getest worden. Het
    verlagen van de drempel tot testing door het aanbieden van een volledig
    geautomatiseerde diagnostische workflow kan een echt verschil maken op
    het gebied van het testen van longkankerbiomarkers, wat een van onze
    belangrijkste strategische pijlers in de oncologie is."

    --- EINDE ---

    Meer informatie:

    Renate DegraveHoofd Corporate Communications & Investor Relations Biocartis

    e-mail rdegrave@biocartis.comhttps://www.globenewswire.com/Tracker?data=7Pr5QJU1P0WZxs72pvtSuz0BQNpyTtqBhGJ65qALJevjzhfWRc_PdtPzsLtommE1JrDU3vp80-FL7H1eJsB9TFIPNVhWbt6kqpBUDHhXjAY=

    tel +32 15 631 729

    gsm +32 471 53 60 64
  2. Flatlander 4 mei 2021 15:04
    Luft

    This would appear to be a win-win-win for AZN, for Biocartis and for the hospitals where Idylla consoles are placed.

    AZN wins by identifying EGFR mutations quicker, I'm sure they they will have ads or promotional information available (maybe on preloaded ads on Idylla) to steer the appropriate patients to their products such as Tagrisso. This may be the difference in AZN capturing the script before a competitor.

    BCART benefits by placing more consoles and cartridges in high use oncology practices. We don't know the financial specifics, but I doubt that BCART is discounting the console costs since they are already pretty low. I wonder what percentage of the Idylla console cost is being picked up by AZN and whether they are subsidizing the cartridges? I would not be surprised to learn that AZN is paying 100% of the console costs. It looks like the deal is a likely predecessor to an EU approval of the Tagrisso CDx.

    Hospitals win by cheaper access to MDx results allowing appropriate treatment for patients more quickly. I don't know the financial situation of hospitals in the EU coming out of the pandemic. It could be that the deal is signaling that there are financial constraints that had to be overcome. If this is the case, I think it is great move for AZN helping bring cost effective MDx to struggling hospitals should earn some good will.

    So, I love the deal since it does not take another 3 years to implement! Also, expect a similar agreement in China as soon as the IVD registration is complete.

    FL
  3. Flatlander 4 mei 2021 17:53
    I reread my last post. So as not to seem too optimistic or like a company shill, the potential value of this newest AZN agreement really depends on the financial terms which are not disclosed. BCART is looking to make headway into lung cancer practices, if AZN funds this sufficiently, it could certainly help. My guess is that only larger practices that can generate a considerable number of scripts will be funded.
    FL
  4. Flatlander 4 mei 2021 22:01
    One last point on todays AZN PR. It could be one of the more bullish partnership announcements we have seen since the payoff could be immediate rather than 3-5 years down the road. AZN likely knows that many Dr. visits have been deferred during the pandemic. I suspect they want to deploy the Idylla consoles in a timely manner so as to be in position to reap the script benefit as the oncology MDx backlog will be the greatest in history.

    FL
  5. forum rang 4 Hopende 5 mei 2021 08:22
    quote:

    Flatlander schreef op 4 mei 2021 22:01:

    One last point on todays AZN PR. It could be one of the more bullish partnership announcements we have seen since the payoff could be immediate rather than 3-5 years down the road. AZN likely knows that many Dr. visits have been deferred during the pandemic. I suspect they want to deploy the Idylla consoles in a timely manner so as to be in position to reap the script benefit as the oncology MDx backlog will be the greatest in history.

    FL
    When do you think we w'll see something in the course that climbs
  6. Flatlander 5 mei 2021 15:12

    "When do you think we w'll see something in the course that climbs"

    I follow a number of MDx companies, all are trading well off of the 52 week high. Many of these companies are perceived to be associated with the shutdown. Wall St appears to be emphasizing re-opening plays right now. So MDx is out of the momentum crowds favor right now. Believe it or not, BCART is fairing better than most MDx sector stocks right now. I know BCART is not currently on the NYSE or NASDAQ but the US seems to set perceptions on which sectors are hot. My thesis in BCART is that they offer a means to automate MDx resulting in secular growth, so I'm less concerned with short term momentum flows.

    AZN may start assisting with the placement of Idylla consoles during the 2nd half of this year but I suspect that two milestones will be necessary before this program can really ramp up, 1) the Tagrisso CDx will need EU approval. As I previously mentioned Idylla has an amplification curve issue with the EGFR T790 mutation which is important to the molecular pathway that Tagrisso utilizes.. BCART is working to improve the sensitivity for this mutation. I think we will see the improved combination assay next year. 2) the 2nd milestone is the gene fusion receiving IVD rather than RUO approval. Again I hope to see this play out within the next year.

    So most of this in terms of increased cartridge sales is probably a 2022 and beyond story but BCART may start to see a benefit in terms of console placements at the end of this year.

    FL
  7. forum rang 4 Hopende 5 mei 2021 19:30
    quote:

    Flatlander schreef op 5 mei 2021 15:12:

    "When do you think we w'll see something in the course that climbs"

    I follow a number of MDx companies, all are trading well off of the 52 week high. Many of these companies are perceived to be associated with the shutdown. Wall St appears to be emphasizing re-opening plays right now. So MDx is out of the momentum crowds favor right now. Believe it or not, BCART is fairing better than most MDx sector stocks right now. I know BCART is not currently on the NYSE or NASDAQ but the US seems to set perceptions on which sectors are hot. My thesis in BCART is that they offer a means to automate MDx resulting in secular growth, so I'm less concerned with short term momentum flows.

    AZN may start assisting with the placement of Idylla consoles during the 2nd half of this year but I suspect that two milestones will be necessary before this program can really ramp up, 1) the Tagrisso CDx will need EU approval. As I previously mentioned Idylla has an amplification curve issue with the EGFR T790 mutation which is important to the molecular pathway that Tagrisso utilizes.. BCART is working to improve the sensitivity for this mutation. I think we will see the improved combination assay next year. 2) the 2nd milestone is the gene fusion receiving IVD rather than RUO approval. Again I hope to see this play out within the next year.

    So most of this in terms of increased cartridge sales is probably a 2022 and beyond story but BCART may start to see a benefit in terms of console placements at the end of this year.

    FL
    Thanks
  8. forum rang 4 Hopende 6 mei 2021 07:06
    quote:

    Flatlander schreef op 5 mei 2021 15:12:

    "When do you think we w'll see something in the course that climbs"

    I follow a number of MDx companies, all are trading well off of the 52 week high. Many of these companies are perceived to be associated with the shutdown. Wall St appears to be emphasizing re-opening plays right now. So MDx is out of the momentum crowds favor right now. Believe it or not, BCART is fairing better than most MDx sector stocks right now. I know BCART is not currently on the NYSE or NASDAQ but the US seems to set perceptions on which sectors are hot. My thesis in BCART is that they offer a means to automate MDx resulting in secular growth, so I'm less concerned with short term momentum flows.

    AZN may start assisting with the placement of Idylla consoles during the 2nd half of this year but I suspect that two milestones will be necessary before this program can really ramp up, 1) the Tagrisso CDx will need EU approval. As I previously mentioned Idylla has an amplification curve issue with the EGFR T790 mutation which is important to the molecular pathway that Tagrisso utilizes.. BCART is working to improve the sensitivity for this mutation. I think we will see the improved combination assay next year. 2) the 2nd milestone is the gene fusion receiving IVD rather than RUO approval. Again I hope to see this play out within the next year.

    So most of this in terms of increased cartridge sales is probably a 2022 and beyond story but BCART may start to see a benefit in terms of console placements at the end of this year.

    FL

    When do you estimate i can reach my GAK of 8,65 in one year ?
  9. [verwijderd] 6 mei 2021 12:03
    quote:

    Hopende schreef op 6 mei 2021 07:06:

    [...]

    When do you estimate i can reach my GAK of 8,65 in one year ?
    Ik vrees dat we daar nog wel even op moeten wachten. Je weet natuurlijk nooit he (vb wat doet een FDA goedkeuring met de koers ?), maar dat zou meer dan een verdubbeling van de huidige beurskoers zijn. Dit in combinatie met een nakende geldronde, shorters, enz ... ik vrees dat 8.65 er niet inzit het volgende jaar.
  10. forum rang 4 Hopende 6 mei 2021 12:26
    quote:

    tomtesteron schreef op 6 mei 2021 12:03:

    [...]

    Ik vrees dat we daar nog wel even op moeten wachten. Je weet natuurlijk nooit he (vb wat doet een FDA goedkeuring met de koers ?), maar dat zou meer dan een verdubbeling van de huidige beurskoers zijn. Dit in combinatie met een nakende geldronde, shorters, enz ... ik vrees dat 8.65 er niet inzit het volgende jaar.
    Maar waarom blíjven ze toch zakken hebben toch goede vooruitzichten
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