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  1. Flatlander 6 juli 2021 15:29
    quote:

    CGCDLR schreef op 4 juli 2021 15:42:

    Thanks FL,do you still believe in a stand alone future for Biocartis?Qaigen forms alliance with Sysmex(cancer diagnostics).Quidel is also looking for purchasing a "competitor". There is a lot of movement in the sector,my opinion, sorry for my bad English.
    CGCDLR

    I think the synergies between the IVD kit producers, reagent providers and NGS system providers result in natural potential for collaboration and partnerships. If you recall the BCART slideshow showing how few supplies are required for the Idylla system, it is apparent that the system is dependent on no partner provided supplies. A lot of the partnerships that have occurred (Archer -NVTA, Qiagen-Sysmex, ...) have occurred between companies that were already providing components for the testing workflow.

    The biggest questions in my mind is whether fast TAT results will become as ingrained in oncology testing as it did in infectious disease, Cepheid grew its franchise on GenExpert, can BCART do the same with Idylla? I keep pointing out niches where Idylla might find more traction. The Covance partnership should be a no brainer since qualifying drug trial participants for a clinical trial would seem to be a good fit for the current RUO authorizations. Emerging markets (particularly in Asia) would also seem to be a good fit since NGS is less prevalent, and the incidence of certain mutations (EGFR) are high enough to warrant destructive testing of a limited amount of sample.

    BCART needs the geographic registrations and it needs a killer app (a test where fast TAT of results is really valued) to emerge. It is frustrating to see the current price action, but it is noise, The price got more than cut in half with the distributor stumble in the US, how might it respond with successful registrations in US, China and Japan. In the meantime, the focus on cartridge volumes )especially oncology if they would break it our) coming out or the pandemic is critical. People are coming out of the pandemic seeking treatment for conditions they have delayed treatment, Idylla allows automation of testing at a time that sample volumes are up and labs are trying to socially distance workers. This would seem to be a great tailwind.

    Unfortunately, we have to wait for the 1st half results for the next snapshot of the pace of uptake.

    FL
  2. forum rang 4 Hopende 7 juli 2021 12:58
    quote:

    Flatlander schreef op 6 juli 2021 15:29:

    [...]

    CGCDLR

    I think the synergies between the IVD kit producers, reagent providers and NGS system providers result in natural potential for collaboration and partnerships. If you recall the BCART slideshow showing how few supplies are required for the Idylla system, it is apparent that the system is dependent on no partner provided supplies. A lot of the partnerships that have occurred (Archer -NVTA, Qiagen-Sysmex, ...) have occurred between companies that were already providing components for the testing workflow.

    The biggest questions in my mind is whether fast TAT results will become as ingrained in oncology testing as it did in infectious disease, Cepheid grew its franchise on GenExpert, can BCART do the same with Idylla? I keep pointing out niches where Idylla might find more traction. The Covance partnership should be a no brainer since qualifying drug trial participants for a clinical trial would seem to be a good fit for the current RUO authorizations. Emerging markets (particularly in Asia) would also seem to be a good fit since NGS is less prevalent, and the incidence of certain mutations (EGFR) are high enough to warrant destructive testing of a limited amount of sample.

    BCART needs the geographic registrations and it needs a killer app (a test where fast TAT of results is really valued) to emerge. It is frustrating to see the current price action, but it is noise, The price got more than cut in half with the distributor stumble in the US, how might it respond with successful registrations in US, China and Japan. In the meantime, the focus on cartridge volumes )especially oncology if they would break it our) coming out or the pandemic is critical. People are coming out of the pandemic seeking treatment for conditions they have delayed treatment, Idylla allows automation of testing at a time that sample volumes are up and labs are trying to socially distance workers. This would seem to be a great tailwind.

    Unfortunately, we have to wait for the 1st half results for the next snapshot of the pace of uptake.

    FL
    This means we could slide down till the 02/09 ? That is normally the date of results
  3. Flatlander 9 juli 2021 20:06
    www.wondfocartis.com/news/aid/89/cid/...

    Wondfocartis announced a strategic collaboration with Feishuo Biotech yesterday, Once again the press release is fairly obscure so it is not completely clear what the significance might be. I do read that Feishuo has lab facilities and is committed to tumor gene precision diagnostics. .I read it as a positive that agreements are being announced out ahead of the registration. Hopefully they are purchasing some units to familiarize themselves with the RUO offerings.

    FL
  4. Flatlander 10 juli 2021 00:13
    xiamen spacegen co. ltd company information

    pitchbook.com/profiles/company/435417...

    Looks like they are a distributor of NGS, PCR equipment and supplies. In keeping with my history of jumping to conclusions, I'm guessing that this partnership is part of the registration documentation process. A few weeks ago I posted a link describing the China registration process. Since they passed the lab testing step around January, I guessed that they were about 70% through the process. What primarily remained looked like an exercise in documenting aspects of the business. If this is in fact a marketing agreement, I'm guessing that they are getting even closer to registration approval. I think Wondfo will act as a distributor/marketing coordinator in many provinces however, from what I understand provincial approvals will be required so additional partners may be required to get access to some other provinces. I think the Chinese government wants details on all aspects of the business from manufacturing to marketing.

    Just a guess from another cryptic news release.

    FL
  5. OzDx 10 juli 2021 07:17
    Good news. Looks like development in China is going well. Wonder when Biocartis will start seeing $$$? Probably still a while away. Marketing Idylla as part of a suite of testing equipment is probably good strategy for underdeveloped market (in molecular/companion diagnostics) like China.

    I'm growing more skeptical about the potential upside of Septicyte. I came across this research piece by WHO (See host response assays chapter* apps.who.int/iris/handle/10665/326480 ) and realized how competitive this market is. I have no doubt SeptiCyte Rapid will get the FDA approval but not sure how fast the market will adopt. Food for thought
  6. OzDx 10 juli 2021 07:36
    Not that anyone should care, I started trimming my other holdings and adding Biocartis. I reckon those 2 multi centre studies, especially the one done by Memorial Sloan Kettering is a game changer. Imo, we'll start seeing explosive growth in oncology assay sales in the US. Downside risk is minimal at current TEV.
  7. Flatlander 10 juli 2021 17:18
    quote:

    OzDx schreef op 10 juli 2021 07:17:

    Good news. Looks like development in China is going well. Wonder when Biocartis will start seeing $$$? Probably still a while away. Marketing Idylla as part of a suite of testing equipment is probably good strategy for underdeveloped market (in molecular/companion diagnostics) like China.

    I'm growing more skeptical about the potential upside of Septicyte. I came across this research piece by WHO (See host response assays chapter* apps.who.int/iris/handle/10665/326480 ) and realized how competitive this market is. I have no doubt SeptiCyte Rapid will get the FDA approval but not sure how fast the market will adopt. Food for thought

    Hey Oz.

    The Wondfo suite surprised me in two ways. 1) It is being marketed in that way while Idylla is only approved for RUO. They must anticipate registration soon. 2)The original partnership with Wondfo stressed that the agreement was highly contingent on cartridge manufacturing in China. It makes more sense to test the market to establish demand before launching the 3rd manufacturing line. If the Chinese can build a hospital in Wuhan in a week or two then I don't anticipate that a manufacturing line would take too long.

    With regard to Septicyte. I think Immunexpress has a first mover advantage in the host response test category. There are many assays that look at the pathogen. Imflammatrix is pursuing the same type of Host Response biomarker. but there are others coming fast.

    www.aacc.org/cln/articles/2020/april/...

    I listened to a Webinar about POC MDx a few weeks ago Sweeny from Imflammatrix was one of the participants. One of his quotes is one that would bother me if I was developing an outside Biocartis position.

    "It is a very brave company that develops a POC MDx platform to address the oncology market. I'm just not sure that there is a critical need for fast POC diagnostic results in oncology"

    I cringed when he said this since it is the heart of the Idylla business model. I also thought immediately to an earlier article I read that more than 70% of lung cancer biomarker testing was missing the NCCN Clinical Practice Guidelines In Oncology for EGFR test result TAT (strive for actionable results in less than 2 weeks).

    Ultimately, I think the point "is there a critical need for fast TAT results" should be considered in future partnerships and assay development.

    Hav e a good weekend.

    FL

  8. Flatlander 12 juli 2021 22:57
    Hi Dave

    We had some brief discussions a few weeks ago. I took issue with the statement that the Idylla costs were higher. The comparison only looked at reagents for NGS vs the Idylla cartridge costs. It is apparent that the University Hospital had a dedicated NGS platform and had personnel working the lab. Labor and the capital cost of purchasing an NGS system were not included in the cost comparison.

    All in all it is pretty favorable and should underscore the ease of Idylla and the use to expedite treatment. The potential for false negatives will need to be addressed through NGS.

    Thanks for posting the link.

    FL
  9. Stockbrood 14 juli 2021 19:30
    quote:

    Hopende schreef op 13 juli 2021 20:49:

    Ik hoop op eens goed nieuws want bio kost me veel stress, biocartis, mithra, celyad man man ik zou er graag vanaf zijn
    Als ik jouw posts lees kan ik me niet van de indruk ontdoen dat je een te grote speculatieve positie in biotech hebt.

    Je wacht een stijging af om er dan vanaf te zijn. Dat lijkt mij niet de goede insteek als belegger...

    Veel succes, en vergeet niet dat een gebalanceerde portefeuille je veel stress bespaart. En in een gebalanceerde PF is ook plaats voor ( wat ) biotech.

    Veel succes
6.527 Posts
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