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  1. Flatlander 9 mei 2020 17:59

    • Flatlander

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    quote:

    FilipVanderAa schreef op 8 mei 2020 11:40:

    [...]

    I guess biocartis is still a long way behind with about 175000 cartridges sold each year.
    Do you know how many different tests can run on their instrument?
    Do you have any idea of the average time between registering a test or medicine for approval and receiving the approval or does this vary greatly?
    What is your take on the insider buying of Verrelst? A sign for things to come?

    Greetings,
    Filip
    Filip

    175,000 was the volume of cartridges in 2019. That represented growth of 32% over the 2018 sales. In a normal year I'd a project similar growth rate in 2020. However, with the pandemic cancer biopsies are way down. How long that number can stay suppressed is anyone's guess. My guess is someone with with a lump in their breast, or blood in their stool will not want to wait more than a month or two. Routine colonoscopies in cases with no symptoms will probably be delayed. So I think some procedures that can't be deferred are ramping up right now. But it is likely the total number will be lower than a typical year. That said, BCART is rolling out Septicyte Rapid in the next month or so in the EU and later in the year in the US. The Covid 19 test (assuming EUA) will likely roll out in both the EU and the US later this year. There is tremendous need for these test and I'm guessing that they may launch with the assistance of JnJ. So it could find traction quickly. Long story short there are too many moving parts for BCART to maintain the 2020 guidance.

    As far as the number of Assays on the market I'd direct you to page 12 of the attached corp presentation. Eight have received EU marking for diagnostic use, 17 (including the 8) have been approved for for research use only. The ultimate number of assays is limited only by the number of genetic mutations of interest to drug developers etc. This content number will grow throughout the foreseeable future.

    investors.biocartis.com/sites/default...

    Your question about the approval time frames is somewhat of a guess, since BCART did not announce the date that they began meeting with FDA to establish approval pathways for various assays. In the case of MSI, I think it is likely that they began negotiations with the FDA inearly 2019 when the EU approval was eminent. So pre-application submittal have likely been ongoing for more than a year. During this time, BCART has been collecting the data that FDA indicated they wanted to see. If they file the PMA submission late this year it will likely be that approval will not be received until the 1st half of 2021. So this process will be more than 2 years in the making before approval. The PMA is the most comprehensive and stringent of the approval pathways. Often this pathway is used where there is no comparable device already on the market to provide a basis of comparison. The 510K process is somewhat less stringent and usually requires a comparison to an existing device or analysis method. I'm guessing that this 510K approval pathway is at least 12 to 18 months. The two processes are described in the attached link. Both of these are way too long! Former FDA director Scott Gotlieb was reportedly working on streamlining these processes when he quit the Agency. The entire MDx testing system is biased toward CLIA labs that are able to get relatively quick approvals for NGS testing in a prescribed lab. I have to tell myself that the approval process barriers will become a moat to slow competitors when Idylla finally garners the approvals. Also, NGS testing is not very transferable to the POC environment. So my hope is today's pain is tomorrow's gain.

    www.fda.gov/medical-devices/premarket...

    Finally, with regards to CEO purchases of shares, it is a positive. When I CEO spends more than half of his annual salary to purchase shares it is a good sign. As the old adage goes "there are many reasons for insiders to sell shares but only one reason to buy." I was posting on this board that I thought he should send investors a positive sign by purchasing. I'm glad he did.

    Ok MB, another chapter for the book! As I said all along, I just want to contribute to a balanced forum for a company that I think holds considerable promise. This is going to play out over a very long time. But the next year should be transitional in setting the momentum for future growth. When these factors become evident the share price will undergo re-valuation.

    FL
  2. [verwijderd] 10 mei 2020 11:14

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    investors.biocartis.com/sites/default...

    investors.biocartis.com/sites/default...

    Above 2 links are the only thing I could find relating to the Extraordinary Shareholder's meeting of May the 8th, which mainly seemed to revolve around agreeing on the proposal of a potential capital increase.

    In another post I found:
    "De jaarvergadering van Biocartis heeft vrijdag ingestemd met alle agendapunten. Dit maakte het diagnostiekbedrijf na afloop van de vergadering bekend. "

    -- I don't know what the agenda points of this general meeting were though, anyone who knows where to find that?

    The post also mentions the below:
    "Er was geen deliberatie en stemming over de items op het agenda van de buitengewone algemene aandeelhoudersvergadering, omdat het aanwezigheidsquorum voor een dergelijke vergadering niet bereikt werd, zo meldde Biocartis."

    Does this mean that there was no vote yet on the potential capital increase?
    The second link mentions that if the quorum of presence is not reached there will be another extraordinary meeting on 9 june 2020.

    Enjoy the weekend
    Thomas
  7. Lucid 13 mei 2020 16:03

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    Mijn enige aandeel in de plus vandaag dus hopelijk blijft het groen. Wel vreemd eigenlijk dat ze bij negatief marktsentiment positief staan en wanneer de rest positief staat, dan gaat Biocartis regelmatig in het rood. Is me een eigenaardig aandeel geworden in verhouding met enkele jaren terug. Hopelijk komen we ooit nog eens terug boven de 10. Ik geloof in het bedrijf maar het aandeel is echt een klucht geworden.
  8. Flatlander 14 mei 2020 15:31

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    I heard an interesting quote on a podcast yesterday that made me think of Biocartis.

    "Emergencies do not result in novel change, but rather accelerate changes that were already underway"

    Several of the changes required to respond to the pandemic play to Idylla's strengths. For instance
    the shift to POC monitoring with quicker, actionable results; the automation of processes in order to foster social distancing; the ability to recover actionable results from samples with degraded DNA; and most recently the ability to rapidly diagnose sepsis (the leading cause of death in COVID fatalities).

    Regards FL.
  9. Flatlander 14 mei 2020 23:28

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    Recent Poster on Seticyte Rapid Validation

    ccforum.biomedcentral.com/articles/10...
    P481 Clinical performance of a rapid sepsis test on a near-patient molecular testing platform
    R Brandon1, J Kirk2, T Yager2, S Cermelli2, R Davis2, D Sampson2, P Sillekens3, I Keuleers3, T Vanhoey3
    1Immunexpress, Seattle, United States; 2Immunexpress, Immunexpress, Seattle, United States; 3Biocartis NV, Biocartis, Mechelen, Belgium
    Introduction:

    The purpose of this study was to clinically validate a new, rapid version of the SeptiCyte™ assay on a near-patient testing platform (Biocartis Idylla™). SeptiCyte™ LAB is the first-in-class sepsis diagnostic to gain FDA-clearance but has a complex workflow and a turnaround time (TaT) of ~ 6 hours. The assay in Idylla™ cartridge format is called SeptiCyte™ RAPID.

    Methods:

    SeptiCyte™ LAB was translated to the Biocartis Idylla™ near-patient testing platform and analytically validated. For this study, 0.9mL of peripheral blood PAXgeneTM solution from previously collected patient samples was pipetted directly into the cartridge and inserted into the Idylla™ reader. Patients were part of an independent cohort (N=200) from Intensive Care Units located in the USA and Europe. SeptiCyte™ RAPID results were reported as a SeptiScore™ between 0 and 10 with higher scores representing higher probability of sepsis. Assay performance determined included technician hands-on-time (HoT), assay TaT, failure rates, and Area Under ROC Curve based on comparison to retrospective physician diagnosis.

    Results:

    Average HoT was 2 minutes, and average TaT was 65 minutes. Clinical samples could be processed immediately with SeptiCyte™ RAPID and did not require 2 hour pre-incubation of PAXgene blood, greatly improving TaT. Correlation of SeptiScore™ values between LAB and RAPID, based upon a subset of samples run on both platforms, was very high (R2>0.97). Estimated ROC AUC performance for discriminating sepsis from non-infectious systemic inflammation (NISI/SIRS) was similar to that previously reported for SeptiCyte™ LAB.

    Conclusions:

    This is the first demonstration of a validated, fully-integrated, rapid, reproducible, near-patient, immune-response sepsis diagnostic, providing actionable results ~ 1 hr, to differentiate sepsis from non-infectious systemic inflammation / SIRS.

    FL
  10. Flatlander 15 mei 2020 03:18

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    While I'm waiting for those of you in the EU to wake up, I'll point out what I considered to be the most important revelation from the preceding poster presentation.

    "Methods:
    SeptiCyte™ LAB was translated to the Biocartis Idylla™ near-patient testing platform and analytically validated. For this study, 0.9mL of peripheral blood PAXgeneTM solution from previously collected patient samples was pipetted directly into the cartridge and inserted into the Idylla™ reader. "

    Apparently the Septicyte shift Idylla has reduced the volume of blood required for the analysis. The blood volume was identified as a major impediment to using the test on infants. Sepsis is a leading cause of infant mortality. The blood draw limit for infants is considered to be 1 ml. I've excerpted a discussion of the Septicyte test that lists this limitation (below).

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

    Host-Targeted Technologies
    SeptiCyte Lab.SeptiCyte Lab (Immunexpress Inc., Seattle, WA) is the first RNA-based technology that targets specific human inflammatory markers using 2.5 ml whole blood for sepsis determination in 4 to 6 h. It has 510(k) clearance from the U.S. FDA for use as an aid in differentiating infection-positive (sepsis) from infection-negative systemic inflammation (SIRS) in critically ill patients on their first day of ICU admission.

    SeptiCyte Lab is a host response-targeted, reverse transcription-quantitative PCR (RT-qPCR)-based test that quantifies the relative expression levels of four RNA biomarkers (CEACAM4, LAMP1, PLA2G7, and PLAC8) known to be involved in innate immunity and the host response to infection. In the discovery phase, microarray analysis was used to identify RNA biomarkers that could differentiate patients with sepsis from patients with postsurgical infection-negative systemic inflammation (186). These biomarkers were then converted to a RT-qPCR format and used to develop the SeptiCyte Lab test for sepsis (186). SeptiCyte Lab is rapid, robust, and accurate for classifying patients with infection-related sepsis across gender, race, age, and date of ICU admission (186). It has been suggested to be an indicator of the probability and not the severity of sepsis (187, 188). In a pilot study using 2.5 ml of blood, SeptiCyte Lab effectively discriminated between two groups of critically ill pediatric patients (40 children with clinical severe sepsis syndrome versus 30 children with congenital heart disease). The area under the curve (AUC) in receiver operating characteristic (ROC) curve analysis, which describes the probability that a test will rank a positive incident higher than a negative one when chosen at random, was used to discriminate between the two cohorts. Even for different RNA analysis techniques, an AUC value of >0.9 was obtained (0.99 versus 0.95), indicating high accuracy. In another prospective observational study with 129 adult ICU patients, an AUC of 0.88 was obtained to discriminate SIRS from sepsis. SeptiCyte Lab scores have shown the ability to classify sepsis better than individual or combinations of other clinical, demographic, and laboratory markers (189).

    SeptiCyte is a promising, novel, broad-based diagnostic test for sepsis. The current 4- to 6-h turnaround time can potentially be reduced to a targeted 1.5 h by optimizing the RT-qPCR platform on which the test is implemented. One drawback is the requirement for 2.5 ml of blood, which is not feasible for use on neonatal populations. Additionally, this test does not provide any information about the pathogen or its antibiotic resistance. However, a determination of infection-negative SIRS could serve to limit antibiotic treatment. More clinical studies across different patient populations are needed to confirm the ability of SeptiCyte to improve outcomes in the clinic. Nonetheless, it has the potential to play a role in reducing inappropriate empirical antibiotic use, which could be of tremendous value in light of the recent antibiotic resistance epidemic. This technology has not yet commercially launched, and no cost information is available at this time. Combining SeptiCyte with pathogen- and resistance-targeted tests that work within the same critical time frame could generate significant synergy, with the potential to enhance the overall NPV of these diagnostic tests and their impact on antibiotic use. Furthermore, such combined approaches may deepen our understanding of the progression of infection-related sepsis.
  13. Flatlander 15 mei 2020 14:41

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    Joe

    These are trying times. I know the temptation to sell everything and run for the hills. I share my research because I believe it may help some have the confidence to hold on despite the tough times. I do not see many products in a growing need area that are critically received by scientists and in the process of launching worldwide. Today BCART is scratching the surface of this market due to the RUO restrictions. As those restrictions slowly come off, the market opportunities will become visible and the share price will appreciate. My only regret is I wish I more fully understood the the inertia and the pace of gaining the diagnostic approvals.

    FL
  14. Flatlander 15 mei 2020 14:48

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    If BCART can gain the EUA and launch its COVID 19 test later this year, there will still be a strong market for fast accurate results. Abbott's ID Now has such a high false negative rate that it should be pulled from the market. The Cepheid test has about the same TAT as Idylla (based on the RSV test) and is about 98& accurate. I expect the Idylla product will be similar.
    FL
    www.cnbc.com/2020/05/14/fda-data-sugg...
  17. Flatlander 20 mei 2020 14:34

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    Pretty quiet here.

    The Sepsis testing market is heating up. Danaher is launching its own test.

    healthcare-in-europe.com/en/news/earl...

    www.prnewswire.com/news-releases/beck...

    However, the test looks like it is meant for the lab with numerous batch samples run at one time. To me that is not truly POC and will likely lengthen the time from sample to answer.

    Anyone still around?

    FL
  18. Flatlander 20 mei 2020 14:49

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    www.prnewswire.com/news-releases/beck...

    Based on the video, the Danaher system seems pretty complex with a lot of moving parts. If they rushed it out to try to beat Septicyte to market, I think we might find out that it is prone to mechanical issues. I also suspect that it will likely take longer than Septicyte. Given the throughput, it looks like a piece of equipment that is best run in batch mode, meaning time is lost compiling a group of samples for analysis. I don't have any evidence of any of this other than the videos.

    FL
  19. [verwijderd] 20 mei 2020 20:32

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    quote:

    Flatlander schreef op 20 mei 2020 14:34:

    Pretty quiet here.

    The Sepsis testing market is heating up. Danaher is launching its own test.

    healthcare-in-europe.com/en/news/earl...

    www.prnewswire.com/news-releases/beck...

    However, the test looks like it is meant for the lab with numerous batch samples run at one time. To me that is not truly POC and will likely lengthen the time from sample to answer.

    Anyone still around?

    FL

    I read an interview with rudi de winter today. He's the ceo of x-fab silicon foundries. He was talking about their collaboration with thermo fisher and boehringer Ingelheim for the production of so-called labs on a chip and Point of Care. I just hope biocartis has a big enough advantage over the competition.
  20. DRTVR 20 mei 2020 20:51

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    quote:

    FilipVanderAa schreef op 20 mei 2020 20:32:

    [...]
    Zou het dan zo simpel zijn om alles waarmee BC zo lang bezig is, dat dit ineens kan ingehaald worden, ik hoop het niet ...
  21. CGCDLR 20 mei 2020 20:51

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    Dag FL, nog steeds lees ik met veel interesse u & andere bijdrage(s).Ergens wachten we allemaal op een trigger die een richting bepaald voor Biocartis.Ik ben sedert jaren aandeelhouder en mijn positie blijft behouden.
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