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  1. Flatlander 21 mei 2020 23:29
    Here is a link to the MSK webinar on EGFR work flow.

    I thought it made a pretty good case for incorporating Idylla EGFR analyses into the workflow. It would be helpful if they can develops a procedure for resolving the analyses on stained cytology smear samples (removal of stain etc.). Hopefully the recommended flow charts become widely implemented.
    FL

    event.on24.com/wcc/r/2289516/25F8119E...
  2. Flatlander 29 mei 2020 00:14
    AZN is jumping in the after hours on the release of an ASCO paper (on-line this year) on its NSCLC Drug Tagrisso.

    finance.yahoo.com/news/astrazeneca-un...

    BCART has partnered with AZN for both the solid and liquid EGFR tests for use as a CDx for this drug. Since this is early stage cancer with great survival numbers 89%, there looks to be a great
    market for the drug. Combine this with last weeks presentation by MSK and things look good for BCART's worldwide entry into the lung cancer market.

    FL
  3. Nestel95 29 mei 2020 10:51
    quote:

    Flatlander schreef op 29 mei 2020 00:34:


    If the ctEGFR study goes well, I'd expect an announcement that they are extending the agreement to China.

    FL


    Hi Flatlander

    Which timeframe are we looking at for this study and announcement? It seems we have a resistancelevel around 4.75. I'm back in track after I took some profit past month.

    Thank you for your updates.

    Kind regards
    Nestel
  4. brightlight 29 mei 2020 12:25
    FL
    Your thoughts, please, on the following:
    Do you think we are in for a positive surprise at the H1 numbers (due to the accelerated move to POC because of Covid-19) or a negative surprise because of the reduced access to hospitals of the sales teams? Have any of the other biotechs that you follow reported on this issue of limited Covid-19 access to hospitals?
    Concerning the high projected cash burn, I wonder if it cannot be explained by some sort of provision for Covid-19 (in stead of a large one time investment, which was my initial thought). Maybe there is room for a positive surprise, then.
    Concerning ctEGFR, I find it strange that, considering the sales potential of Tagrisso, no trajectory has yet been set in motion to get CE IVD approval. Or did I miss something? What study are you referring to?
    BL
  5. Flatlander 29 mei 2020 19:01
    Nestel

    I'm not the person to follow when it comes to timing. I'm on record on this board saying I thought OncoTypeDx Breast was a late 2019 launch. If you look at the ASCO abstracts there are a few EGFR related studies out of China. I think that bodes well for registration approvals later in the year. Because they locked down hard in January, I think their oncology treatments are getting back to normal. Europe and the US are behind. Because of the smoking rates in Asia and the incidence of EGFR mutations, I think this will be great market for Idylla. The Chinese claim they average 3-7 days for NGS data TAT. However, there are still issues where recovering actionable NGS results is an issue. I think there is a nice role for Idylla corroborating targets.

    The Septicyte/Covid data is probably a 2nd half story but it may also move the needle. There are a lot of moving parts that could impact SP both positively and a few negatively. This is a very trying time. As I said before, I anticipate that some MDx firms do not survive it. In the short run they may have added COVID testing that helps offset demand that eroded elsewhere. As the COVID testing begins to decline there will be a scramble to raise cash. The thing to keep your eye on is what firms are gaining oncology MDx market share. I want to see if the pandemic acts as an accelerant for the Idylla streamed lined work flow. I think you will probably get a good re-entry point during the summer before the news flow for the 2nd half picks up.

    FL
  6. Flatlander 29 mei 2020 19:49
    quote:

    brightlight schreef op 29 mei 2020 12:25:


    FL
    Your thoughts, please, on the following:
    Do you think we are in for a positive surprise at the H1 numbers (due to the accelerated move to POC because of Covid-19) or a negative surprise because of the reduced access to hospitals of the sales teams? Have any of the other biotechs that you follow reported on this issue of limited Covid-19 access to hospitals?
    Concerning the high projected cash burn, I wonder if it cannot be explained by some sort of provision for Covid-19 (in stead of a large one time investment, which was my initial thought). Maybe there is room for a positive surprise, then.
    Concerning ctEGFR, I find it strange that, considering the sales potential of Tagrisso, no trajectory has yet been set in motion to get CE IVD approval. Or did I miss something? What study are you referring to?
    BL


    BL

    In the U.S. I'm hearing that since March that oncology procedures (colonoscopies, breast lumpectomies, biopsies, etc.) are down 70%. GenomeWeb documents that the majority of oncology MDx companies are seeing much lower test volume and anticipate it will continue into the 2nd quarter. This is not the makings of a great first half for BCART on an absolute basis. However, as discussed in the previous post, emergencies often accelerate trends. BCART could be a huge winner if the relative comparisons are better than competitors (i.e., BCART shows evidence of gaining market share). If labs, hospitals, clinics etc. increase their Idylla usage because it simplifies testing in an age of social distancing, it could be setting usage trends that thrive long after the pandemic is over. There will likely be meager new console placements until the 2nd half. In the 2nd ha Septicyte/Covid may act as a driver for new console placements. Similarly Asia registration approvals may also drive placements (since they seem to be managing the pandemic in a way that is allowing a quicker return to normalcy).

    I hope you are right that the cash usage is directed toward the COVID launch. There is still critical need for an accurate fast test. Dr. Fauci has cast doubt on the Abbot IDNow test and referenced that Cepheid is a much more accurate platform. I suspect that Idylla can reach similar accuracy levels. I'm hopeful for the placement of Idylla systems in ICUs. Pediatric and neo natal ICUs have especially been identified as having an intense need for a fast sepsis test. With the lower blood draw requirements of septicyte rapid, it looks like it could be a good fit for this market. So yes I think there is room for a surprise, but it is probably a 2nd half story.

    The Master collaboration agreement with AZN includes a study evaluating how rapid ct EGFR characterization might benefit the launch of Tagrisso. The MSK webinar that ran last week discussed the use of Idylla to help resolve difficult (low volume cytology samples). Based on Dr. Maria Arcila indicated that about 25% of the NGS testing could be cancelled in cases where Idylla yielded positive mutation results (i.e., NGS testing could be avoided, thus saving costs). NGS is more sensitive, so if Idylla yields negative results, potential exists that the mutations are present but below Idyllas sensitivity range, so negative samples would still need to be submitted for NGS analysis. I'm sure AZN is looking at this relationship as a means of accelerating Tagrisso scripts.

    Got to go.
    FL

    www.globenewswire.com/news-release/20...

  7. Flatlander 1 juni 2020 16:41
    Attached is a link to a really long article on COVID in the US, The 1st third of the article deals with MDx and has several points that are relevant to BCART, The sections on contact tracing and treatments/vaccines can probably be skipped.

    finance.yahoo.com/news/coronavirus-va...

    It is important to recognize that much the PCR equipment being referenced (Cobas etc) is also used for oncology MDx so the bottlenecks affect both Covid and cancer testing. I found this section especially interesting.

    "Lack of Centralized IT and Logistics Capabilities
    We think this, perhaps, is the most significant factor in the near and mid-term that prevents us from turning our theoretical test capacity into reality. Getting the specimen from the healthcare provider to a lab with the appropriate equipment platform that has space in its overnight batches is difficult without a centralized information system. Then, take hundreds of thousands of specimens, multiplied by thousands of healthcare providers, multiplied by hundreds of labs, and by a handful of major equipment platforms. This quickly turns into a massive matching game to get each specimen to the right lab at the right time. "

    Idylla definitely alleviates many of these problems.

    Regards FL

  8. Flatlander 2 juni 2020 04:16
    Interesting interview with Dr. Rolland Carlson, the founder of Immunexpress.

    www.appliedclinicaltrialsonline.com/c...

    This part is especially pertinent to BCART.

    MA: What is the value of this diagnostic to physicians and patients? Especially during times, like now with COVID and increasing patient volumes in the ICU?

    RC: Our test is designed for people with a strong suspicion of sepsis. However, 44% of the time, those patients suspected of sepsis don’t actually have sepsis. Regardless, all patients suspected of sepsis are admitted to the ICU, and there just aren't enough ICU beds to compensate for these patients. This problem is now exacerbated by the COVID pandemic. So, the utility of our test is extremely valuable right now.

    Additionally, patients with COVID are ultimately dying from a virally-induced systemic inflammatory response: this is viral sepsis. When a COVID-positive patient comes into the ER, they are assessed over a series of hours and many times are sent home. This is where our tests could have high utility. Our test can detect whether or not a patient is starting to go down that true sepsis cascade due to the virus.

    Our test is designed to pick up viral induced sepsis, bacterial induced sepsis and fungal induced sepsis. For COVID patients, we're seeing that the cascade starts with viral sepsis, but could lead to a bacterial coinfection. Because we measure the patient’s gene activation to a potential sepsis event, we are not limited to only finding the invading pathogen. Of course, if a COVID-positive patient is determined to have sepsis, he or she would not be discharged, but admitted into the ICU.

    We are modifying our clinical trials right now at the request of the U.S. government to make sure that we can include COVID-positive patients. We've submitted a grant to the U.S. government for accelerated emergency use authorization of our test for COVID triage.


    My take:
    The Bad News: The US approval is likely delayed since the clinical trial has been altered to include triage of COVID positive Sepsis cases.

    The Good News: Positive results from such a clinical trial would make this an extremely important test. I don't know about the EU but numerous COVID positive patients have been discharged from emergency rooms only to either die at home or return to the hospital a short time later.

    This could be very big. The trials should have no trouble enrolling sufficient patients,so I think we could have results and an EUA furing the 3rd quarter.

    Regards FL




  9. Flatlander 3 juni 2020 00:08
    Looks like BCART has ramped up its distribution network throughout the world. Most of western Europe is served by BCART out of Belgium but they identify alot of outside distribution partners throughout the world. My guess is that this is in anticipation of Septicyte Rapid product launch in the near future.

    Someone out there want to go through the list and check it against the list of countries that follow the EU marking of a new MDx product. I think this is a statement of much larger anticipated geographically distributed demand compared to its Oncology MDx products.

    Unfortunately, we will only have a few weeks of distribution during the 2nd quarter, so we might have to wait a while to track the sales numbers associated with this new product.

    FL

    www.biocartis.com/en/in-your-country
  10. Flatlander 5 juni 2020 21:51
    Invetech POC best practices. As posted previously, I'm pretty sure this is BCARTS contracted manufacturing partner for the consoles. I tried to post the PDF but the file size was too big, so use the link.

    The graph on page 19 suggests that BCART can still cut the cost of each cartridge in half if they can reach full capacity. In the graph case 1.2 million cartridges per year.

    FL

    www.genomeweb.com/resources/white-pap...
  11. Ocean Seven 9 juni 2020 16:49
    Heeft er iemand een idee wat de stand van zaken is met het oog op de eigen opstart van het sales team in de US? Ik zie geen Sales vacatures openstaan in Amerika.
    Verwachten we eigenlijk iets van trigger voor we de halfjaarlijkse resultaten, begin september, krijgen?
    We dobberen nu al ongeveer een maand rond de 4.6-4.9.
  12. RUF RTR 9 juni 2020 17:28
    Er is wel degelijk een team verantwoordelijk voor de USA, zowel naar sales, r&d, technische ondersteuning.
    Een week geleden verscheen op de linkedin pagina van Biocartis een foto van het US-team met als titel
    “The Biocartis US team is still going strong”
    Het is biotech dus niets valt uit te sluiten op vlak van nieuwsberichten zowel positief als ook negatief natuurlijk.
  13. Flatlander 10 juni 2020 14:47
    I'm quite optimistic about the launch of Septicyte Rapid. I've done a good deal of research and I believe the test is ideally positioned for Covid triage use. Because the test is Host Response RNA based rather than pathogen based, it is directed at the cytokine storm that is at the root of the Covid deaths. Almost all Covid deaths are attributed to sepsis resulting from this cytokine storm.

    In the switch from Septicyte Lab to Septicyte Rapid Biocartis has addressed two of the use limiting factors identified in the attached review.

    cmr.asm.org/content/31/2/e00089-17

    1st the Rapid test may now be run on 0.9 ml of blood making it appropriate for all age groups including infants.

    2nd the TAT has been cut from 4 to 6 hours to 65 minutes.

    Combine these factors with the ease of use and I think Septicyte could well be the "Killer Ap" that drives console placements. I have previously hypothesized that BCART suffered from a Chicken and Egg problem. In order to attract new partnerships the number of console placements needs to increase so as to increase the attractiveness of the platform. But to drive console placements, Idylla needs "a must have assay" that provides something not available on other platforms. Septicyte especially during the pandemic fits that bill. If by mid 2021 we are talking about console placements well in excess of 2500, the system will have the kind of momentum that attracts partners and new content. My review of the history of Cepheid's Gene Expert launch found that pandemic fears (H1N1, TB, etc.) often drove sales. Initially, I did not think this would help BCART since they were focusing on oncology, but septicyte has the potential to place a lot of units in emergency rooms and ICU's. After this pandemic, the equipment utilization for other assays will likely increase. If I'm right about increased console placement, BCART will need to target a cross marketing campaign in the future to foster increased oncology assay usage.

    I always though that OncoType Dx would be the driver for system uptake. I now think that driver is Septicyte.

    FL


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