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Aandeel Biocartis BRU:BCART.BL, BE0974281132

  • 0,290 22 sep 2023 17:35
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Biocartis forum geopend

6.263 Posts
Pagina: «« 1 ... 256 257 258 259 260 ... 314 »» | Laatste | Omlaag ↓
  1. forum rang 4 Flatlander 31 januari 2022 00:05
    As we look at 2022 with the cash coffers running down I need to think about some things that could have a material impact of the trajectory. The following events could double the number of consoles in use in relatively short order:

    MSI 510K approval in the US. - IHC and other commonly used methods tend to be labor intensive so there is an opportunity to expedite the workflow by incorporating Idylla into the lab workflow.

    Nichirei Bioscience as indicated the intent to integrate Idylla into its network of 2000 pathology labs upon successful registration as indicated from the Hi 2019 PR. We are now looking at several assays being approved before the end of the year.

    " Japan commercialization - On 7 January 2019, Biocartis announced to have signed an agreement with Nichirei Bioscience, a leading supplier of biological and diagnostics products in Japan, for the product registrations and distribution of the Idylla(TM) platform in Japan. Upon successful registration, Nichirei Bioscience's sales force will commercialize the Idylla(TM) platform across its network of some 2,000 pathology laboratories."

    China registration of EGFR, BRAF and MSI would unlock IVD use in a market that is not oversaturated with NGS testing facilities. Government reimbursement will likely require additional time but the system would fill an immediate need in smaller cities that are looking for a cost effective way to to provide MDx testing capacity. It is not unreasonable to assume that the registration approvals could unlock IVD opportunities resulting in a couple thousand console placements.

    The SkylineDx merlin assay is already available in a lab form in the U.S. Market and they have applied for Medicare and insurance reimbursement. This assay is supported by research from the Mayo Clinic one of the most prestigious cancer hospitals in the U.S.. A test that enables unnecessary lymph node biopsies is a cost saver and likely to be strongly supported by insurers. Therefore I can see a case for wide adoption. Depending on the insurance reimbursement rate their could be a significant incentive for the practice to offer the test on Idylla. There are approximately 7800 dermatology practices in the US. This is most likely a late 2023 into 2024 opportunity, but it is a large one.

    I focus on these opportunities to significantly ramp the number consoles since it would create the often talked about inflection point in the cartridge sales. Right now BCART management needs to stabilize things, provide a palatable option for funding the company. To the extent that these opportunities remain on the table, BCART needs to revisit and highlight these opportunities so that the investment community can see the path to profitability that does not require 5 more years.

  2. forum rang 4 Flatlander 31 januari 2022 14:57
    A couple things you can look for during the call include:

    1) Strategy for raising cash sufficient to bridge to profitability;
    2) Update on Manufacturing Line #3 in China;
    3) Status update on Asia registrations;
    4) Status of MSI 510K FDA registration (could come at any day);
    5) Conservative and beatable guidance on console placements and cartridge sales;
    6) Status of fire insurance reimbursement and reagent stock build;
    7) Hopefully an announcement of the release date for the BRAF-EGFR cartridge. This should include the necessary corrections to the T790 mutation amplification curve; and
    8) Look for evidence of growth favoring areas including the EU and ROW (S. America etc) where Idylla has full IVD use approvals. Unfortunately we have not gotten specific geographic number breakdown to look at this quantitatively.

    As I've said on many occasions, the increase in retirements, the push for decentralized MDx, and the backlog of testing from deferred preventative health testing all are factors that should provide a tailwind for the type of automated MDx testing provided by BCART.

  3. ElTorro 3 februari 2022 16:56
    Klein pakketje met niet te veel risico ;-)
    Ik verwacht dat ze nog verder gaan zakken zolang er geen zekerheid is rond de financiële toestand.
    Moeten snel geld ophalen om dit en volgend jaar cashburn te overleven en in 2024 hangt er nog een molensteen rond de nek. Zolang de marges blijven zoals ze nu zijn (30/40%) gaat het niet lukken vrees ik.
    Opschalen productie en sales, goedkeuringen en financiën op orde krijgen.. het management weet wat gedaan.
  4. Bonsjoer 3 februari 2022 17:07
    Idd. beperkt terug ingestapt, verwacht deels ook dat ze nog verder zakken.., alleen wil ik mezelf geen slecht humeur bezorgen als er om 7:00 een positief mailtje binnenkomt :D , met goedkeuring FDA MSI oid.., verder verwacht ik nog wel wat positief nieuws wat de verwachtingen voor dit jaar betreft., en duidelijkheid over de financiering.., dat hangt nu als een zwaard van Damocles boven Biocartis.
  5. ElTorro 3 februari 2022 18:39
    Goed nieuws zoals goedkeuring in US zijn idd welkom en zullen even naar positieve daytrades leiden, maar dan zal het snel weer de orde van de dag zijn, de belegger wil nu echt wel weten hoe ze de weg naar winstgevendheid gaan vinden, en dit met een slinkende zak centen. In het huidig beursklimaat nog een IPO lanceren in US, problematisch.
  6. forum rang 4 Flatlander 4 februari 2022 04:01
    This Genome Webinar kind of makes the case for Idylla.

    Identifying Meaningful Mutations in Tumor Testing With a Somatic Database
    Date: February 10th, 2022
    Time: 7:00 am PT / 10:00 am ET / 4:00 pm CET

    Precision medicine is transforming cancer care, with next-generation sequencing (NGS) enabling the simultaneous analysis of multiple genomic alterations with therapeutic implications. However, due to the sporadic nature of somatic cancers and the increasing uptake of NGS testing, the number of detected variants is exponentially growing, challenging labs to confidently identify meaningful mutations that could influence or improve decisions at the point of care. Approximately 50 percent of the oncologists in the United States find NGS results sometimes or often difficult to interpret, while 31 percent of small to medium-sized labs in Europe view a lack of knowledge and exposure to routine analyses and interpretation as the most critical bottleneck in NGS testing [1-2].

  7. forum rang 10 voda 4 februari 2022 07:06
    PERSBERICHT: Persbericht Biocartis Group NV: Openbaarmaking van een transparantiekennisgeving

    4 februari 2022, 07:00 CET

    Openbaarmaking van een transparantiekennisgeving

    Mechelen, België, 4 februari 2022 -- Biocartis Group NV (de 'Vennootschap' of 'Biocartis'), een innovatief bedrijf in de moleculaire diagnostiek (Euronext Brussels: BCART), kondigt vandaag aan, overeenkomstig artikel 14, lid 1 van de Belgische Wet van 2 mei 2007 op de openbaarmaking van belangrijke deelnemingen in emittenten waarvan aandelen zijn toegelaten tot de verhandeling op een gereglementeerde markt (de 'Belgische Transparantiewet'), dat zij op 2 februari 2022 een transparantiekennisgeving (de 'Kennisgeving') heeft ontvangen waaruit blijkt dat op die datum, het totale aantal stemrechten en gelijkwaardige financiële instrumenten in het bezit van Credit Suisse Group AG (onrechtstreeks via andere Credit Suisse entiteiten) is gestegen tot 3,68%, zoals hieronder verder wordt toegelicht.

    De Kennisgeving bevat de volgende informatie:

    -- Reden van de Kennisgeving: Verwerving of overdracht van
    stemrechtverlenende effecten of stemrechten.

    -- Kennisgeving door: Een moederonderneming of een controlerende persoon.

    -- Kennisgevingsplichtige persoon: Credit Suisse Group AG, Paradeplatz 8,
    CH-8001 Zürich, Zwitserland.
    -- Transactiedatum: 28 januari 2022.

    -- Kennisgevingsdrempel die is overschreden: 3%.

    -- Noemer: 57.545.663.

    -- Details van de Notificatie: Credit Suisse Group AG bezit nu
    (onrechtstreeks via andere entiteiten van Credit Suisse) in totaal
    1.276.367 stemrechten (d.w.z. 2,22% van het totale aantal
    Biocartis-aandelen tegenover 3,08% waarvan op 11 oktober 2021 aan
    Biocartis kennis is gegeven) en 839.165 aandelen die het aan
    derden in bruikleen heeft gegeven met het recht deze op elk moment
    terug te roepen (d.w.z. 1,46% van het totale aantal
    Biocartis-aandelen), wat een totale positie van 3,68% oplevert.

    -- Volledige keten van gecontroleerde ondernemingen via dewelke de
    deelneming daadwerkelijk wordt gehouden: Credit Suisse Group AG,
    Credit Suisse AG, Credit Suisse Asset Management InternationalHolding Ltd., Credit Suisse Asset Management & Investor Service
    (Schweiz) Holding AG, Credit Suisse Fund Management S.A. / Credit
    Suisse Group AG, Credit Suisse AG, Credit Suisse (Schweiz) AG /
    Credit Suisse Group AG, Credit Suisse AG, Credit Suisse
    Voor verdere informatie wordt verwezen naar de Kennisgeving die hier ter beschikking is op de website van de Vennootschap.

    Krachtens de Belgische Transparantiewet en de statuten van de Vennootschap is een kennisgeving aan de Vennootschap en aan de Belgische Autoriteit voor Financiële Diensten en Markten ('FSMA') vereist door alle natuurlijke personen en rechtspersonen, telkens wanneer het percentage van stemrechten in de Vennootschap gehouden door zulke personen de drempel van 3%, 5%, 10%, en ieder verder veelvoud van 5%, van het totale aantal stemrechten in de Vennootschap bereikt, overschrijdt of onderschrijdt.

    ----- EINDE ----
  8. OzDx 6 februari 2022 09:11
    Check out this article published in my home country :)
    Validation of EGFR mutation testing on cytological smears of lung cancer using the Idylla platform
    " In conclusion, this study demonstrates that utilising the Idylla EGFR mutation assay on destained Diff-Quik stained slides obtained from EBUS-TBNA procedures is 100% concordant with current laboratory based methods for mu-tation testing, even in low cellularity smears without enrichment. The control EGFR Cq values suggests that Diff-Quik stained slides are superior to FFPE material for this assay. By utilising this method in the management of patients with lung cancer, clinicians can
    obtain a rapid same day result for EGFR mutation status, reserving FFPE cell block and biopsy material for immunohistochemistry, fluorescence in situ hybridisation and NGS and reducing the need for further diagnostic procedures with associated risks."

    Idylla solves real life problem many diagnostic labs are facing day to day.

    I also like to keep track of how many pubmed publications there are each year and it's consistently going up year on year.
    I'm looking forward to listening to annual earnings call on the 24th.
  9. forum rang 4 Flatlander 8 februari 2022 05:59

    Very similar take aways to an article that ran about two years ago. Reusing cytology smear samples makes a ton of sense since it is hard to obtain quality samples with sufficient viable DNA material. Looks like standardizing the de-staining protocol and running short courses for cytology labs would be well received.

  10. Stockbrood 9 februari 2022 07:09
    Dan bij deze:

    Biocartis and Ophiomics to Collaborate on
    Liver Cancer Test
    • Primary liver cancer
    is the sixth most common and third most lethal cancer in the world
    • Collaboration to focus on commercialization of HepatoPredict™, a prognostic gene expression signature test to identify
    which patients will benefit from liver transplantation
    Mechelen, Belgium, 8 February 2022 - Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative
    molecular diagnostics company (Euronext Brussels: BCART), and Ophiomics, a Lisbon (Portugal) based biotech
    company developing a precision medicine portfolio focused on liver cancer, today announce that they entered into
    a collaboration which will initially focus on the commercialization of HepatoPredict™, a prognostic gene expression
    signature test to help identify which patients will benefit from curative-intent surgery, in particular liver
    transplantation. HepatoPredict™ will be distributed by Biocartis in Europe as a manual kit mainly addressing
    centralized expert laboratories, and the test may later be translated into a version on Biocartis’ rapid and easy-to?use molecular diagnostics platform Idylla™.
    Primary liver cancer is the sixth most common and third most lethal cancer in the world, with more than 900,000
    new cases per year resulting in more than 800,000 deaths per year2
    . Hepatocellular carcinoma (HCC) is the most
    common type of primary liver cancer that frequently occurs in people with chronic liver diseases, such as cirrhosis3
    Treatment options include ablation4
    , surgical resection5 or transplantation, with liver transplant being the most
    effective curative treatment for HCC patients with cirrhosis6
    . Due to shortage of donor organs, the proper selection
    of patients is crucial. Current models to select patients are sub-optimal7
    , leading to potential exclusion of patients
    that may benefit from surgery.
    HepatoPredict™ is a gene expression signature test that combines clinical parameters with molecular markers to
    assess the tumor biology, aiming to predict which patients will benefit most from liver transplant and identifying
    those for which a transplant should be avoided. HepatoPredict™ has been validated retrospectively with
    encouraging results, increasing the number of patients that can benefit from curative-intent transplantation by
    . Further prospective and retrospective validation is ongoing9
    HepatoPredict™ will be launched as a CE-marked IVD manual kit in Q1 2022. The partnership will initially focus on
    Biocartis’ commercialization of the manual kit in Europe. In a next stage, depending on successful commercial
    uptake of the manual kit, Ophiomics and Biocartis aim to initiate the development of a fully automated version of
    the test on Biocartis’ decentralized Idylla™ platform.
    Herman Verrelst, Chief Executive Officer of Biocartis, commented: “We are excited to partner with
    Ophiomics to improve outcomes for liver cancer patients. The availability of a manual kit version of the Ophiomics
    test allows us to help patients and generate commercial traction right from the start of the collaboration while we
    prepare to bring this test onto our Idylla™ platform to maximize patient access to the test long term.”
    José Pereira Leal, Chief Executive Officer of Ophiomics, added: “We are thrilled to be initiating this
    collaboration with a company that is complementary to Ophiomics’ vision to develop effective precision medicine
    solutions that enable patients and healthcare providers to make the best treatment decisions. This partnership will
    enable us to immediately leverage Biocartis’ commercial organization for an early access to the European market,
    anticipating future, closer collaboration on this and other assays.”
6.263 Posts
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