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  1. Flatlander 2 maart 2019 17:24
    Biocartis has priced their cartridges at a point where there is room for the clinic or hospital to mark it up and receive reimbursements from the insurers. With the 510(k) pathway approval, point of care users will make a nice profit off the use of Idylla. That combined with the fast turn around time will greatly expedite adoption of the platform.

  2. forum rang 10 DeZwarteRidder 2 maart 2019 18:49

    Flatlander schreef op 2 maart 2019 17:24:

    Biocartis has priced their cartridges at a point where there is room for the clinic or hospital to mark it up and receive reimbursements from the insurers. With the 510(k) pathway approval, point of care users will make a nice profit off the use of Idylla. That combined with the fast turn around time will greatly expedite adoption of the platform.

    Je beweert dus dat Biocartis veel te weinig geld vraagt voor het gebruik van Idylla-cassettes zodat het ziekenhuis er veel winst mee kan maken...!!!??

    Dat zou betekenen dat Biocartis over 10 jaar nog geen winst maakt.
  3. Flatlander 2 maart 2019 20:30
    In the U.S the insurance reimbursement rates are determined by the specific genomic pathway panel being analyzed (BRAF, KRAS etc). The reimbursement rate will not be influenced by whether it is analyzed by a NGS method in a lab vs. an IVD test in the clinic where the biopsy is taken. Because Idylla's competitors are largely lab based with greater technician effort, reagents, steps etc. the competitors currently have much higher costs. Biocartis has chosen to initially price at a reasonable margin that puts the assay cost well below competitors. This leaves the clinical lab where the Idylla test is run the potential to mark up the costs considerably and still receive full insurance reimbursement. I believe that ones the 510(k) pathway approvals are received that the adoption rates will take off in the US since the clinics will have a strong economic reason to use the test (i.e., they can bill it out for 100% profit). It remains to be seen how Biocartis will change the cartridge billing rate once 501(k) approval is received for clinical diagnostic use. Arguably, they should increase the price.

  4. Flatlander 4 maart 2019 16:30
    Biocartis is currently getting little credit (based on share price doldrums) for several positive developments including:
    expansion of GHDX partnership into Urology;
    China and Japan market expansion;
    Product offering expansion in MSI;
    AstraZeneca CDx partnership

    Many of these deals allow Biocartis to leverage limited resources by having their partner carry some of the regulatory burden. This is important now when profitability is still a couple of years off. At times I'm frustrated that BCART has not listed in the US. Looking at how GH has performed since it IPO'd, I believe that BCART could raise a lot more cash with less dilution. I've convinced myself that this is balanced by the advantage that they are currently flying under the radar building momentum (increased product offerings, geographic expansion) without a huge target on their back. Too much visibility on the NYSE or Nasdaq would undoubtedly draw competitors. At some point I'm sure BCART will list in the US (at least it seems to be the trail that QGEN and others have taken). In the mean time BCART generated good technical reviews. I was impressed by the attached link that suggested Idylla has a place for 1st line diagnostic pathology. Placement in this setting (clinics, hospitals, small labs, etc.) would be allow huge expansion. This is obviously dependent on expanding beyond the RUO designation, That's why the emphasis on 510(k) pathway approvals are critical.

  5. tomtesteron 7 maart 2019 11:46

    Flatlander schreef op 6 maart 2019 15:27:

    Anyone on the board have any thoughts on the China joint venture with Wondfo. Will the intellectual property be protected adequately?


    I think the wondfo JV will prove to be very successful in the future:
    China is a country where due to pollution there is a high incidence of cancers. Alligning the cartridge portfolio to these types of cancers can in my perspective open a huge market potential.

    I also think that Biocartis and its CEO are smart enough to be aware of the potential risk of intellectual property breaches. By choosing Wondfo as their partner, they choose a market leader in China who is also active in the US (lab in San Diego and brancg in Chicago), and in 120 countries in total. They are seen as a trustworthy partner.
  6. Flatlander 7 maart 2019 16:22
    Thanks, I agree with your assessment of the market potential. I hope you're right on the trustworthiness of Wondfo. When I first invested in Biocartis, I tried to research the patent portfolio. I recall that they have approximately 40 patents and license agreements protecting various aspects of their technology. Of course, this all depends on a legal system that is willing to enforce intellectual property rights.

    I was a bit disappointed with the year end results but was pleased with the initiatives identified for 2019. I believe the ramp up in the U.S. is constrained because of the RUO designation. The sales reps have to be very careful not to cross the line in marketing it as a clinical diagnostic device.

    I'm always intrigued by the potential for Idylla to be used to disseminate partner sponsored ads and educational material. Idylla is in effect a very valuable ecosystem that is positioned to dispense valuable information at the time of biopsy or genetic pathway diagnosis. The placement of such information or ads at such a pivotal time in the patient treatment is invaluable and could make BCART a preferred partner for CDx relationships. This is all a ways off, and BCART needs to ramp console placement and cartridge volumes before entertaining any partner sponsored ads.

    I'm glad I finally found a forum to discuss Biocartis.

  7. Flatlander 7 maart 2019 23:45
    Anyone know the status of the Immunexpress -Biocartis relationship? The attached article suggests that Immunexpressis rounding up additional funding to advance the Septicyte IVD


    However, I don't recall any mention of it on the Feb 28 update. Furthermore, the following statement
    on page 4 of the Feb 28 Press Release leads me to believe that Biocartis is terminating the ImmunExpress collaboration.

    "Contract terminations – During H2 2018, a review of infectious disease oriented collaborations and license agreements was conducted, which resulted in the termination of certain collaborations that were no longer of strategic importance to Biocartis. As part of this review, the agreement with Koninklijke Philips N.V., under which Biocartis had gained access to certain patent rights and know-how, in relation to an ancillary platform for selective enrichment of pathogen DNA for use with bloodstream infection tests, has been terminated. The underlying patent rights are being returned to Philips and the related book value has been fully impaired, resulting in EUR 3.2m non-cash impairment.

    The ImmunExpress relationship appears to have existed for several years (+/- 2012 -six years before last years announcement) but does not appear to be advancing.

    Other than strategic decision to emphasize oncology related assays for business/cost related reasons,, is there another factor that has limited progress on the septicyte IVD assay? The fact that this has been kicking around for so long makes it look like some type of technical constraint.

  8. Flatlander 13 maart 2019 01:18
    Good news on the CDx collaboration with Bristol Myers for MSI. I used to get upset that BCART was operating totally under the radar in the US. Now I'm thinking it may be a strategic advantage. They have been able to secure CDx agreements with 5 major pharma companies,, launched Idylla in every major market in the world and are in the process of validating the GHDx Oncotype Dx Breast IVD assay (only test shown to predict whether a patient will benefit from Chemotherapy). If the OncoType prostate test is half as strong an assay this could be a very long running profitable collaboration. These collaborations are coming to BCART without drawing a number of copycat oncology IVD competitors.

    Like they have said in many of the conference calls, this is a multiyear journey. I've switched to using these benchmarks to track progress rather than focusing on the share price,

  9. Flatlander 13 maart 2019 17:40
    Thanks. I'm not trying to monopolize the posts on this board. I see a lot of potential for BCART and I've been looking for a forum to discuss the company. Outside of IVD oncology competition (does not currently seem to be a concern), the major risk seems to be that NGS may get cheaper and faster in the future. That is fine, I believe that is still a ways off. There will always be a need for timely information at the time of biopsy/diagnosis.

  10. Flatlander 15 maart 2019 15:32
    The China IVD registration process appears complex. The extent to which validation studies conducted in foreign markets may be utilized to support the registration is unclear. Once registered, the IVD test is generally not reimbursed by insurance for a period of 2 years. During this time the patient bears the cost for the test. The attached article does provide a perspective on the immense potential of the China IVD market. Looks like we should be prepared for this to play out in a 3 to 5 year time frame.
  11. Flatlander 15 maart 2019 15:48
    This statement is encouraging:

    "While all Class II and III IVDs have been required to go through local clinical studies in China, China’s State Council recently issued new regulations on October 8, 2017 that should allow some foreign clinical trial data for medical device and IVD registration. Trials must be conducted at multiple centers and meet CFDA registration requirements. These changes should be positive for Western medical device manufacturers, reducing the need for local clinical trials, lowering market entry costs, and cutting the time needed to achieve registration. Avoiding the need for a local clinical trial could reduce the IVD registration timetable by about one year. What remains unclear is which IVD products will be able to use data from foreign clinical trial data."

    If this plays out favorably, might it be possible to launch sales of of some assays (i.e., Iung CRC) late this year? The cartridges and consoles would need to initially be imported from Belgium until local manufacturing is established.

    Just conjecture.
  12. Flatlander 25 maart 2019 23:09
    Based on today's weakness, it looks like Biocartis might revisit the 52 week lows in the 9's. It got absolutely no traction from the BMY CDx collaboration announcement. I see a variety of late 2019-2020 catalysts but probably not a lot in the near term. Possible catalysts include: 1) A press release from Wondfo (China Partner) or Nichirei Bioscience (Japan Partner) indicating progress with registration and providing a launch date would be a major catalyst. I understand that the Wondfo collaboration will include manufacturing in China. However, why must this preclude launching with cartridges a consoles manufactured in Belgium while the China manufacturing facility is being constructed; 2) Information on the Onco Dx Breast assay validation and specifically when EU approval might be expected will be major news. 3) Similarly, the Onco Dx prostate status will also be welcome news since both of the OncoDx products will serve large markets in the EU and US. 4) Finally, updates on the status of FDA negotiations for approvals of MSI, BRAF, KRAS etc would probably be the biggest momentum maker since this would allow the product to be used for diagnostic purposes rather than RUO. Such an authorization would allow the tests to be reimbursed by insurers. This would undoubtedly allow the sales to ramp in the US.

    One of the things I like most about BCART is that they can leverage the staff and technical resources of their partners (CDx Pharma and content partners like GHDX) to expedite FDA approvals. If FDA makes progress revamping the 510K pathway, I don't see why some of these approvals might not move faster than the guidance. I think the FDA process will eventually get to where the EU Marking procedure has gotten (i.e., about 6 months from filing to approval), but this will likely take a few years.

    In the short term, my best guess is that BCART could go as low as 9.7 and will probably have difficulty breaking 12 without one of the aforementioned catalysts. I've pretty much loaded up, but I may add a little more to my share count.

    Any-one know the reason for the apparent downgrade by one of the analysts?

  13. Flatlander 26 maart 2019 17:56
    I think the price of Biocartis share price has been dragged down by low growth expectations for Europe. The German Bund yields went negative again suggesting that the overall market sees little potential for growth in Europe. Perhaps this macro view is related to the uncertainty over Brexit. I don't think any of this affects the opportunities for BCART.

    Three years from now, we will probably look back at this period being critical. BCART is expanding offerings and is moving toward diagnostic approvals in the U.S. The switch from RUO will allow greater sales in the U.S.. Also, BCART has wracked up 4 CDx agreements without garnering much attention. They have established international distribution partnerships with Fischer Healthcare, Wondfo and Nichirei Bioscience without competition placing a target on their back. I believe that even the current US trade war with China may also be benefiting BCART by limiting US competition (primarily lab based NGS) from making headway in China. BCART is working with limited funds and therefore must proceed cautiously. A large competitor could throw money and try to make up lost ground quickly. This could quickly erode BCARTs head start advantage.

    GHDX has been successful by developing assays that anticipate trends. They have targeted questions that are critical during treatment (i.e., will this woman benefit from chemotherapy, is this man's prostate cancer likely to turn aggressive?). They now have prioritized answering these questions through an IVD platform, so the results are available cheaper, quicker, without sending out tissue samples, etc.). I waited about 3 years for the market to recognize the value in GHDX (an eventual triple). This only occurred after the TailorX release at ASCO last year. GHDX had published numerous similar studies results before the TailorX results were published in the NEJM. It often takes a high profile large study in a reputable journal to make a difference. BCART is building out critical offerings, infrastructure and relationships before they have a big target on their back. I believe that their partners will help with regulatory approvals and eventually author or co-author papers that will speed adoption rates. This all takes time. MDx and CDx are in their infancy. Most hospitals and clinics have not developed standardized approaches yet. This trend will likely play out over a decade or more.

    In the meantime we will need to be patient. Given the progress outlined above, it's hard to believe that BCART still trades below the 2015 IPO price.

  14. Flatlander 1 april 2019 18:47
    Apparently the Septicyte assay on Idylla is not dead yet.
    Immune express announced in Early Feb that they had raised additional funds for the program. The infectious disease IP that Biocartis returned to Phillips must have been unrelated.
    That said, BCART has downplayed this program (I don't even think the partnership is mentioned on any recent Investor Relations info). I stand by my earlier statement that their must be a difficult technical constraint since it is costing more and has been under development for so long.

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