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Merlin Assay Validation results should bode well for government and insurance reimbursements. Hopefully, BCART can get the Idylla IVD version to to the validation stage much quicker than the 3 years that OncotypeDx required.www.prnewswire.com/news-releases/perf... FL
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 samenwerkingsovereenkomstwww.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 FACILITATEwww.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
Iemand die zijn licht wilt schijnen hierop? Wie heeft welk voordeel bij deze samenwerking? Alvast bedankt.
luftbe0 schreef op 4 mei 2021 08:36 :
Iemand die zijn licht wilt schijnen hierop? Wie heeft welk voordeel bij deze samenwerking?
Alvast bedankt.
Meer EGFR cartridges verkopen
De 30 à 40% van de NSCLC patiënten in Azië hinken misschien naar een deur die men wil openen.
tijd om biocartis te kopen....een effe meer geduld hebben
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
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
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
If that is true, then this could be a huge step towards profitability?
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
"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
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
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 ?
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.
Als ze nog eens onder de 4 euro zakken, stap ik terug in.
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
Hopende schreef op 6 mei 2021 12:26 :
[...]
Maar waarom blíjven ze toch zakken hebben toch goede vooruitzichten
Ja, ze gaan eerst nog even naar beneden om jullie op stang te jagen. Kan nog paar jaar duren vooraleer de koers herstelt.
Joshua41 schreef op 6 mei 2021 13:07 :
[...]Ja, ze gaan eerst nog even naar beneden om jullie op stang te jagen. Kan nog paar jaar duren vooraleer de koers herstelt.
Je begint op mij te lijken.....!!!
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