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MDxHealth nieuws 2013

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  1. [verwijderd] 7 oktober 2013 08:45
    omson Reuters /Source: MdxHealth (TM) /XBRU: MDXH /ISIN: BE0003844611

    MDxHealth's ConfirmMDx® Meets All Primary Endpoints in Blinded U.S. Clinical Validation Study


    IRVINE, CA, and HERSTAL, BELGIUM - 8:00 AM, October 7, 2013 - MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, today announced that its ConfirmMDx for Prostate Cancer test met all of the primary endpoints in the recently completed multicenter, blinded DOCUMENT (Detection of Cancer Using Methylated Events in Negative Tissue) clinical validation trial. Preliminary analysis of data verifies the test's high negative predictive value (NPV) for ruling out the presence of prostate cancer and is a significant, independent predictor of risk for men being considered for repeat biopsy.

    "This validation study confirms the high negative predictive value of the ConfirmMDx test in a U.S. population," says Wim van Criekinge, Ph.D., Professor at The University of Ghent and Chief Scientific Officer for MDxHealth. "The clinical utility of this test lies in its ability to reduce unnecessary repeat biopsies, improving patient care and optimizing limited healthcare resources."

    ConfirmMDx for Prostate Cancer is a non-invasive test performed on the residual prostate tissues from the previous negative biopsy, providing critical epigenetic insights beyond histopathology alone, to enable more informed patient management decisions. The multicenter DOCUMENT study was conducted at five major U.S. urologic centers. The study involved analyzing tissue from initial negative biopsies and comparing assay results to cancer detection in subsequent biopsies within 24 months. ConfirmMDx for Prostate Cancer was used to analyze the epigenetic profile of prostate biopsy cores from 350 men screened by PSA. Results from the DOCUMENT study will be published after full analysis of the data is completed.

    "We are extremely pleased with these results, demonstrating that ConfirmMDx for Prostate Cancer validates as a significant, independent predictor for the presence of prostate cancer in a repeat biopsy," said Dr. Jan Groen, CEO of MDxHealth. "These findings are consistent with the results from our earlier European clinical validation study that demonstrated a NPV of 90% (95% CI, 86-94%)".

    About ConfirmMDx for Prostate Cancer
    Over 975,000 American men are diagnosed with a negative prostate biopsy each year; however approximately 25-35% of those men receive false-negative results. Under the current standard of care, prostate biopsy procedures consisting of 10-12 needle biopsy cores only sample approximately 1% of a man's prostate. This approach leaves men at risk of occult cancer, leading to a high rate of repeat biopsies, often on cancer-free men. There is an unmet medical need for a clinically effective diagnostic test to address this dilemma. ConfirmMDx for Prostate Cancer is able to detect an epigenetic field effect or 'halo' associated with the cancerization process at the DNA level. This "halo" around a cancer lesion can be present despite cells having a normal appearance under the microscope. Thus ConfirmMDx for Prostate Cancer aids urologists in identifying truly negative men who may forego an unnecessary repeat biopsy procedure.

    About MDxHealth
    MDxHealth is a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment. The company's tests are based on proprietary gene methylation (epigenetics) technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. For more information visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
  2. [verwijderd] 7 oktober 2013 14:46
    Wat een ge-jojo vandaag.
    Jammer dat er weinig reactie is op de nieuwsbericht(en) die naar buiten komen.
    Misschien dat het event in Japan nog voor een boost kan zorgen.
  3. [verwijderd] 7 oktober 2013 16:09
    quote:

    DennisF schreef op 7 oktober 2013 14:46:

    Wat een ge-jojo vandaag.
    Jammer dat er weinig reactie is op de nieuwsbericht(en) die naar buiten komen.
    Misschien dat het event in Japan nog voor een boost kan zorgen.

    Gaat gebeuren in de nasleep van deze dagen. De nieuwe studieresultaten gaan daar gepubliceerd worden vandaar dat ze vandaag het persbericht ook via reuters hebben doorgespeeld. Wat nieuwe investeerders uit japan kunnen leuke fratsen uithalen met de koers van het aandeel wanneer zij echt gaan geloven in het product van het concern. Ik ben benieuwd naar het koersveloop deze week!
  4. [verwijderd] 7 oktober 2013 16:14
    het Vat,

    seekingalpha.com/instablog/826770-len...

    ....
    In a research report last month, Roderick Verhelst, an analyst with Petercam in Belgium, said that the studies provide further evidence that DNA methylation-based tests are the way of the future in improving the diagnosis and subsequent treatment of cancer patients. "MDxHealth is on the forefront of this field and thus excellently positioned to benefit from this," he added.

  5. [verwijderd] 8 oktober 2013 13:09
    Mdxh is geduld; weinig omzet, weinig nieuws, goede waardering, hoge omzet pas in 2015. Loopt het echter naar 3,30 zien we de 3 euro niet meer terug.
  6. [verwijderd] 10 oktober 2013 01:22
    NEWS!

    MDxHealth and Sumitomo sign Pharmaco Molecular Diagnostic Partnership for Japan

    MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support the diagnosis and treatment of cancer patients, today announced the signing of a partnership with Summit Pharmaceuticals International Corporation (SPI) a subsidiary of Sumitomo Corporation to gain access to the Japanese market with its pharmaco molecular diagnostic (PharmacoMDx) epigenetic technologies and products. Expanding upon MDxHealth's PharmacoMDx program, the partnership aims to provide companion diagnostic solutions, or theranostics, to pharmaceutical companies in the Japanese market. No financial terms have been disclosed.

    "As the global life sciences industry continues to pair diagnostics with therapeutics to determine patient response, we believe this partnership with SPI will provide MDxHealth with the necessary leverage and expertise to penetrate the Japanese market," stated Dr. Jan Groen, CEO of MDxHealth. "We look forward to working closely with the SPI team to offer our unique epigenetic PharmacoMDx products and services to drug development companies."

    MDxHealth's PharmacoMDx team leverages Next-Generation and Deep Sequencing technologies for the identification and validation of powerful epigenetic biomarkers for novel therapeutics. Companion diagnostic assays are playing an increasingly important role in the development process of new compounds as they can help identify patients who may benefit from a new drug, improving efficacy, reducing adverse side effects, and potentially accelerating regulatory approval thereby helping pharma companies reduce the time and cost associated with bringing new products to market.

    Source: MDxHealth

  7. [verwijderd] 10 oktober 2013 01:30
    Lijkt erg goed nieuws voor de langere termijn, helaas zie ik niet zo 1 2 3 wat voor omzet dit genereert op termijn, dus verwacht ik niet zoveel koersreactie op korte termijn. Hopelijk wel natuurlijk !
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