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Home  /   Forum   /   Biocartis   /   Biocartis forum geopend

Aandeel Biocartis BRU:BCART.BL, BE0974281132

Laatste koers (eur) Verschil Volume
0,290   0,000   (0,00%) Dagrange 0,000 - 0,000 0  

Biocartis forum geopend

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6.527 Posts
Pagina: «« 1 ... 269 270 271 272 273 ... 327 »» | Laatste | Omlaag ↓
  4. Flatlander 14 juli 2022 18:57
    A few of the jobs are regulatory affairs personnel in the U.S.
    Is this a sign that BCART is realizing they need to beef up for interactions with FDA? I wish we had more insights into the MSI 510K.

    My biggest fear for BCART is that there product Idylla seeks to disrupt a new high growth field Oncology MDx -personalized medicine- health care automation, etc and as such the regulatory processes may be wired to protect local domestic business. We are seeing regulatory delays through much of the developed world outside of the EU. The FDA approved Promega (a competing MSI assay) much quicker than Idylla which presumably submitted a lot of head to head comparisons supporting the application (something the FDA supposedly weights heavily in the approval process). China has thrown up some regulatory roadblocks that are keeping BCART from even filing any registrations until next year. By my count that is a couple years behind the schedule we had been guided toward. While the Japan registrations for KRAS, NRAS and MSI were filed in November by Nicherei, I believe they are also way behind the initially anticipated schedule. Hopefully the process does not languish and we hear something from Japan soon.

    The commonality, is that each of these markets have domestic MDx businesses that are seeking to compete with Idylla. On the other hand, the approvals in the EU and the emerging markets seem to occur on fairly predictable schedules. At some point, if BCART can collect hard evidence of my suspicions they made need to start taking this up with EU trade officials. Part of the advantage that bigger companies have is that they can put legal and lobbying heft behind their efforts.

    FL
  8. Flatlander 20 juli 2022 14:47
    Good Day

    Don't think the system would allow outright denial if appropriate studies and documentation is filed. I do think they can delay it by requesting additional information or documentation. In the meantime Promega or other competitors have additional time to launch their MSI test or stuff the supply channels with their product. Its crappy but I think it is commonly done worldwide.

    FL
  9. Flatlander 20 juli 2022 19:23
    Mikron Asia had a great 1st half 2022. I think it is a pretty good bet that it was helped by the construction of ML3 for Wondfo-Cartis.
    FL

    "The Mikron Group’s net sales rose from CHF 139.9 million in the first half of 2021 to CHF 145.9 million in the first half of 2022 (+4.3%). A major part of the significant increase in order intake will generate sales in 2023, and in subsequent years. With a 48% share of sales, Europe (including Switzerland) remained the Mikron Group’s principal sales market in the first half of 2022. Mikron increased sales in Europe by 3.4% compared with the first half of 2021, in Asia by 60.8% while the sales in the USA decreased by -13.4%."
  15. Flatlander 15 augustus 2022 20:26

    NSCLCToday 19:08
    www.genomeweb.com/scan/lung-cancer-re...

    A few weeks ago I hypothesized that BCART and LifeArc should strike up a relationship to partner their ABC breast cancer assay with Angle in order to make it more conducive to ctDNA liquid biopsy. The same may be true of patnering EGFR and Gene fusion assays for NSCLC. The article suggests that circulating tumor content may provide an effective means for monitoring disease progression. I can see a possible role for Angle's parasortix in mutation monitoring. I think the same results found for checkpoint inhibutors will be found for other mutation drivers. Thus, ctDNA may well become the prefered method for patient disease monitoring. It is a lot easier to draw a blood sample than to obtain a lung swab or fine needle lung sample. I think the cost of repeated NGS analyses would be prohibitive for most insurers/payers. A combination of Parasortix and PCR sequencing for EGFR, ROS, Alk etc should be much quicker and cost effective. Parasortix may well address some of the sensitivity issues associated with using Idylla for ctDNA analyses.

    Is anyone still out there?

    FL
  19. OzDx 16 augustus 2022 11:35
    Performance of Idylla KRAS assay on extracted DNA and de-stained cytology smears: Can we rescue small sample?

    Abstract
    Objective: KRAS is a frequently mutated gene in cancers, and with recent FDA-approved targeted therapy for the G12C mutation, testing for KRAS variants is essential. We evaluated the performance of the Idylla KRAS assay on extracted DNA and cytology smears in order to expand the utility of the assay.

    Methods: In total, fifty-seven human samples were analyzed. Idylla results from sixteen DNA extracted from formalin-fixed, paraffin-embedded tissues (FFPE DNA) and thirty cytology smears were compared to the reference method. We evaluated the performance of the Idylla assay using corresponding cytology smears to rescue cellblocks or surgical blocks that were quantity not sufficient (QNS) for next generation sequencing (NGS).

    Result: In the FFPE DNA cohort, 10 ng DNA input yielded valid results in all 16 samples, with 15 of 16 (93 %) concordant with NGS findings. In the cytology smear cohort, the Idylla KRAS assay demonstrated 100 % concordance with previous NGS results in 30 cases. In the QNS cohort, the assay was valid in all cases and KRAS mutations were identified in 3 of 11 cytology smears, including one G12C mutation.

    Conclusion: The Idylla KRAS assay is a high-performing, feasible, and convenient option for testing extracted DNA and cytology smears. It rescues QNS samples allowing it to be integrated into the molecular workflow as an initial screening test with remarkably quick turnaround times.

  20. Flatlander 16 augustus 2022 14:50
    Hey Oz,
    What is the date on that article? I read something very similar about 2 years ago, although I recall it being focused on EGFR. Do you have any thoughts on the possible use of Angle Parasortix to harvest circulating tumor for liquid biopsy analyses on Idylla, It seems like it addresses the primary problem that Idylla is not sufficiently sensitive to low circulating tumor levels. If it has utility, perhaps we will hear that BCART and LifeArc are evaluating it for the ABC assay, Parasortix is already approved by FDA for breast cancer.

    FL

6.527 Posts
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