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Home  /  Forum  /  MDxHealth  /  MDxHealth Launches ConfirmMDx for Prostate Cancer

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MDxHealth Launches ConfirmMDx for Prostate Cancer

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Pagina: 1 2 »» | Laatste | Omlaag ↓
  1. [verwijderd] 15 mei 2012 08:32
    * Reuters is not responsible for the content in this press release.
    Tue May 15, 2012 2:00am EDT

    MDxHealth Launches ConfirmMDx™ for Prostate Cancer

    First epigenetic test to help identify men who may avoid repeat biopsies

    Regulatory News:

    MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today announced the launch of ConfirmMDx™ for Prostate Cancer, a novel test that helps urologists distinguish patients who have a true-negative prostate biopsy from those who may have occult cancer. Testing will be performed in MDxHealth’s state-of-the-art Irvine-based CLIA laboratory for physicians submitting prostate tissue samples directly or via its exclusive co-marketing partner PLUS Diagnostics.

    “As many as one in four men could be misdiagnosed due to limitations with current prostate biopsy procedures, commonly described as ‘sampling error’. As a consequence, the standard of care for men with persistently high-risk factors, but no evidence of prostate cancer in a biopsy, is limited to continued surveillance and repeat biopsies, often on prostate-cancer-free men. The ConfirmMDx for Prostate Cancer test detects epigenetic changes associated with the presence or absence of prostate cancer,” explained Prof Dr. Wim van Crienkinge, Chief Scientific Officer of MDxHealth.

    “The launch of ConfirmMDx for Prostate Cancer represents the culmination of extensive research and development efforts and demonstrates the commitment of the MDxHealth team to deliver on its new commercial strategy,” said Dr. Jan Groen, CEO of MDxHealth. MDxHealth is uniquely positioned with its portfolio of epigenetic assays to capitalize on the realization of true personalized medicine, improving patient care, while reducing healthcare costs.”

    About ConfirmMDx for Prostate Cancer

    Over 650,000 American men receive a negative prostate biopsy result each year; however approximately 25-35% of these results are false negative. Under the current standard of care, prostate biopsy procedures collect 10-12 needle biopsy cores on average, effectively sampling less than 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 prostate-cancer-free men. There is an unmet medical need for a clinically effective diagnostic test to address this dilemma. ConfirmMDx for Prostate Cancer is an epigenetic assay to help distinguish patients who have a true-negative biopsy from those at risk for occult cancer. The test helps urologists rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and, helps rule in high risk patients who may require repeat biopsies and potential treatment. The test is able to detect an epigenetic field effect or “halo” associated with the cancerization process at the DNA level in cells adjacent to cancer foci. This molecular “halo” around a cancer lesion can be present despite having a normal appearance under the microscope. Thus ConfirmMDx for Prostate Cancer aids urologists in identifying men who may forego unnecessary repeat biopsies.

    Please visit MDxHealth and PLUS Diagnostics at the American Urology Association Annual Meeting, May 19-23 2012 in Atlanta, GA, booths #3831 and #3923.

    About MDxHealth

    MDxHealth is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. By applying patented DNA methylation platform and biomarkers, MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. For more information visit www.mdxhealth.com and follow us on Twitter at: www.twitter.com/mdxhealth.

    Dr. Jan Groen will present on MDxHealth at the 13th annual meeting BioEquity Europe that is taking place on May 15th-16th in Frankfurt, Germany.

    This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation.

    MDxHealth
    Dr. Jan Groen, CEO
    US: +1 949 812 6979
    BE: +32 4 364 20 70
    info@mdxhealth.com
    or
    Halsin Partners
    Mike Sinclair
    UK: +44 20 7318 2955
    Cell: +44 7968 022075
    msinclair@halsin.com

    www.reuters.com/article/2012/05/15/id...
  3. Debit or Credit 15 mei 2012 10:47
    Nu officieel op de website!

    Press Release
    MDxHealth Launches ConfirmMDx™ for Prostate Cancer
    MDxHealth Launches ConfirmMDx™ for Prostate Cancer
    First epigenetic test to help identify men who may avoid repeat biopsies

    IRVINE, CA, and LIEGE, BELGIUM, May 15, 2012 – MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today announced the launch of ConfirmMDx™ for Prostate Cancer, a novel test that helps urologists distinguish patients who have a true-negative prostate biopsy from those who may have occult cancer. Testing will be performed in MDxHealth's state-of-the-art Irvine-based CLIA laboratory for physicians submitting prostate tissue samples directly or via its exclusive co-marketing partner PLUS Diagnostics.

    "As many as one in four men could be misdiagnosed due to limitations with current prostate biopsy procedures, commonly described as 'sampling error'. As a consequence, the standard of care for men with persistently high-risk factors, but no evidence of prostate cancer in a biopsy, is limited to continued surveillance and repeat biopsies, often on prostate-cancer-free men. The ConfirmMDx for Prostate Cancer test detects epigenetic changes associated with the presence or absence of prostate cancer," explained Prof Dr. Wim van Crienkinge, Chief Scientific Officer of MDxHealth.

    "The launch of ConfirmMDx for Prostate Cancer represents the culmination of extensive research and development efforts and demonstrates the commitment of the MDxHealth team to deliver on its new commercial strategy," said Dr. Jan Groen, CEO of MDxHealth. "MDxHealth is uniquely positioned with its portfolio of epigenetic assays to capitalize on the realization of true personalized medicine, improving patient care, while reducing healthcare costs."

    About ConfirmMDx for Prostate Cancer
    Over 650,000 American men receive a negative prostate biopsy result each year; however approximately 25-35% of these results are false negative. Under the current standard of care, prostate biopsy procedures collect 10-12 needle biopsy cores on average, effectively sampling less than 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 prostate-cancer-free men. There is an unmet medical need for a clinically effective diagnostic test to address this dilemma. ConfirmMDx for Prostate Cancer is an epigenetic assay to help distinguish patients who have a true-negative biopsy from those at risk for occult cancer. The test helps urologists rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and, helps rule in high risk patients who may require repeat biopsies and potential treatment. The test is able to detect an epigenetic field effect or "halo" associated with the cancerization process at the DNA level in cells adjacent to cancer foci. This molecular "halo" around a cancer lesion can be present despite having a normal appearance under the microscope. Thus ConfirmMDx for Prostate Cancer aids urologists in identifying men who may forego unnecessary repeat biopsies.

    Please visit MDxHealth and PLUS Diagnostics at the American Urology Association Annual Meeting, May 19-23 2012 in Atlanta, GA, booths #3831 and #3923.

    About MDxHealth
    MDxHealth is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. By applying patented DNA methylation platform and biomarkers, MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. For more information visit www.mdxhealth.com and follow us on Twitter at: www.twitter.com/mdxhealth.

    Dr. Jan Groen will present on MDxHealth at the 13th annual meeting BioEquity Europe that is taking place on May 15th-16th in Frankfurt, Germany.

    Dr. Jan Groen, CEO
    MDxHealth
    US: +1 949 812 6979
    BE: +32 4 364 20 70
    info@mdxhealth.comCLOAKING
    Mike Sinclair
    Halsin Partners
    UK: +44 20 7318 2955
    Cell: +44 7968 022075
    msinclair@halsin.comCLOAKING


    This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company's control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation.

    English version

    Version Française

  5. [verwijderd] 15 mei 2012 13:57
    MDxHealth lanceert test voor prostaatkanker

    Arne Petimezas - 15 mei 2012, 12:40
    Een test van MDxHealth moet helpen aantonen of er daadwerkelijk sprake is van prostaatkanker.

    Volgens MDxHealth wordt bij mogelijk een op de vier mannen de al dan niet aanwezigheid van prostaatkanker verkeerd gediagnosticeerd. Als gevolg van de diagnostische problemen moeten mannen met een hoge kans op prostaatkanker steeds een biopsie laten doen.



    De test ConfirmMDx moet nu vaststellen of bij een biopsie, een weefseltest, echt geen kanker aanwezig is of dat er wel degelijk sprake van sporen van kanker.



    De tests met het middel zullen worden uitgevoerd in MDxHealths laboratorium in Irvine in de Amerikaanse staat Californië.



    Door: ABM Financial News.
    Info@abmfn.nl
    Hoofdredactie: +31(0)20-737 17 42
    Redactie: +31(0)20-262 29 78

  6. Debit or Credit 15 mei 2012 14:30
    quote:

    boxer2 schreef op 15 mei 2012 13:39:

    Morgen slechte cijfers????
    'k Heb het vaker meegemaakt dat 1 dag voor de cijfers een goed bericht wordt verspreid om zo een koersdip vanwege de slechte cijfers zo veel mogelijk te voorkomen.
    Waarom denk je dat? Ik verwacht veel specifieke details over de cijfers. En zie geen reden waarom de cashburn ver onder de verwachting is.

    DoC.
  7. Debit or Credit 15 mei 2012 15:00
    Door de marketingdeal met plusdx heeft mdxhealth haar netwerk vergroot en extra events op de agenda gezet:

    May 19-23, 2012
    MDxHealth To Present at American Urology Association Annual Meeting
    www.aua2012.org
    June 7-9, 2012
    MDxHealth To Present at 2012 Texas Urological Society Annual Meeting
    www.texasurologist.org/
  8. Debit or Credit 23 mei 2012 09:16
    Press Release
    MDxHealth’s ConfirmMDxTM for Prostate Cancer Test Helps to Identify Men Able to Avoid Repeat Biopsies
    Multi-Center MATLOC Data Presented at AUA Annual Meeting

    IRVINE, CA, and LIEGE, BELGIUM, 23 May, 2012 - January 9, 2012 – MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today announced it has presented data demonstrating that its epigenetic ConfirmMDxTM for Prostate Cancer test can aid urologists in identifying patients who may avoid a repeat prostate biopsy.

    In men suspected to have prostate cancer, the potential for false-negative biopsy results is well documented in the literature. Approximately twenty-five percent of men receiving a negative histopathology result, the gold standard for diagnosis, could be harboring occult cancer. Fear over this issue leads to additional physician visits, screening, and repeat biopsies, often on prostate-cancer-free men. MDxHealth’s ConfirmMDx test assesses the DNA methylation status of genes associated with prostate cancer. The test will help urologists differentiate patients with a true-negative biopsy from those who may have cancer undetected by prostate biopsy and histopathological review.

    The data from the MATLOC (Methylation Analysis To Locate Occult Cancer) study presented during the Late Breaking Science Forum yesterday at the American Urology Association (AUA) Annual meeting in Atlanta, USA, revealed that the ConfirmMDx for Prostate Cancer test is a powerful tool to aid urologists in addressing false-negative biopsy concerns.

    "With a high negative predictive value, exceeding that of standard microscopic histopathology review, the MATLOC study results demonstrate that the ConfirmMDx for Prostate Cancer test can help urologists confirm true-negative biopsy results, providing peace-of-mind and reducing unnecessary repeat biopsies,” explained principle investigator Dr. Grant Stewart from the Edinburgh Urological Cancer Group at the University of Edinburgh, who presented the data. “The test will also help urologists identify high-risk men who may have occult cancer, enabling more effective triage of these patients with a repeat biopsy and treatment as required."

    "These data confirm the high negative predictive value (NPV) and clinical utility of the ConfirmMDx for Prostate Cancer genes and DNA methylation technology previously reported in published studies. We believe the test fulfills an unmet medical need, complementing the current standard of care, and holds the potential to reduce unnecessary invasive procedures and the associated healthcare expenditures. Prostate biopsies pose significant risk of trauma and infection, at times requiring hospitalization. As a consequence, approximately one-third of men refuse to endure a repeat biopsy despite fear of a false- negative result, leaving these men at risk for disease progression. ConfirmMDx, a non- invasive assay performed on the residual prostate tissues from the previous negative biopsy, provides critical insights beyond histopathology to enable more informed patient management decisions," said Dr. Jan Groen, CEO of MDxHealth. "We are pleased to announce that ConfirmMDx for Prostate Cancer is now available to urologists directly through MDxHealth’s state-of-the-art CLIA laboratory, and via our co-marketing partner PLUS Diagnostics.”

    Study Details
    The multicenter MATLOC study involved 3 sites from the UK and Belgium, testing tissue from initial negative biopsies and comparing assay results to cancer detection in subsequent biopsies within 30 months revealing either cancer (cases) or negative results (controls). Individual prostate biopsies comprised 10 separate tissue cores on average. ConfirmMDx for Prostate Cancer was used to analyze the methylation status of a panel of validated biomarkers (GSTP1, APC and RASSF1) in 4,681 archived prostate biopsy cores from 483 men in a blinded fashion. Results demonstrated that the assay had a NPV of 90%

    Application of this assay to initial, negative prostate biopsies accurately identified over two- thirds of patients who had cancer detected on a subsequent prostate biopsy, while correctly confirming negative findings in approximately two-thirds of men who were cancer-free in a subsequent prostate biopsy. The high NPV of 90% indicates this assay could help avoid unnecessary repeat prostate biopsies.

    Approximately 60% of positive assay results were indicated by one methylated gene while the remaining 40% of cases displayed two or more methylated genes. Univariate analyses identified that the methylation panel was a significant predictor of prostate cancer diagnosis. These findings were confirmed with a multivariate logistic regression, correcting for PSA, age, digital rectal examination results prior to initial biopsy and histopathological findings of this biopsy.

    The study entitled “Clinical utility of a multiplexed epigenetic gene assay to detect cancer in histopathologically negative prostate biopsies: results of the multicenter MATLOC study”, was presented by Dr. Grant Stewart from the Edinburgh Urological Cancer Group at the University of Edinburgh, on Tuesday, May 22, 2012 during the late breaking science session. Abstracts from the conference are available online.

    Over 650,000 American men receive a negative prostate biopsy result each year; however approximately 25-35% of these results are false negative. Under the current standard of care, prostate biopsy procedures collect 10-12 needle biopsy cores on average, effectively sampling less than 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 prostate-cancer-free men. There is an unmet medical need for a clinically effective diagnostic test to address this dilemma. ConfirmMDx for Prostate Cancer is an epigenetic assay to help distinguish patients who have a true-negative biopsy from those at risk for occult cancer. The test helps urologists rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and, helps rule in high risk patients who may require repeat biopsies and potential treatment. The test is able to detect an epigenetic field effect or “halo” associated with the cancerization process at the DNA level in cells adjacent to cancer foci. This molecular “halo” around a cancer lesion can be present despite having a normal appearance under the microscope. Thus ConfirmMDx for Prostate Cancer aids urologists in identifying men who may forego unnecessary repeat biopsies.

    About MDxHealth
    MDxHealth is a leading molecular diagnostics 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 www.mdxhealth.com and follow us on Twitter at: www.twitter.com/mdxhealth.
    Dr. Jan Groen will present on MDxHealth on June 19th at 9:30 at the 2012 BioInternational Convention that is taking place in Boston (June 18-21)

    For more information:

    Dr. Jan Groen, CEO
    MDxHealth
    US: +1 949 812 6979
    BE: +32 4 364 20 70
    info@mdxhealth.comCLOAKING
    Mike Sinclair
    Halsin Partners
    UK: +44 20 7318 2955
    Cell: +44 7968 022075
    msinclair@halsin.comCLOAKING


  10. Debit or Credit 27 mei 2012 10:11
    quote:

    Binckie 123 schreef op 25 mei 2012 13:48:

    Armzalig koersverloop! Geduld is bijna op! Hoelang nog?
    Denk dat ik komende week maar weer wat 10k biedblokken erin moet gaan zetten. Als we het algemene sentiment bekijken mogen we niet klagen maar een koersprong met al dit goed nieuws had ik ook wel verwacht! European valdidation is nu erg belangrijk! Gezien de strikte wetgeving in amerika zie ik daarom zeker goedkeuring binnen Europa!

    DoC.
  13. boxer2 1 juni 2012 11:37
    quote:

    Debit or Credit schreef:

    [quote alias=Binckie 123 id=6294835 date=201205290055]
    Wanneer wordt die Europese goedkeuring verwacht?
    [/quote]

    Kan niet lang duren Binckie, pakweg een aantal maanden! Tevens mooie ijsbergbied op 1,47 en 1,50. Er lijkt weer wat te gaan gebeuren!
    Waar zie je die ijsbergen. Ik kan ze niet ontdekken
  15. harrysnel 1 juni 2012 11:56
    quote:

    Debit or Credit schreef op 1 juni 2012 11:52:

    Op 1,47 en 1,50. Je ziet dat er een paar 100 staan in jou boekje terwijl er in werkelijkheid tienduizenden/honderdduizenden staan.
    Dat klopt niet, ik verkocht 10k. Merendeel (8488) is gegaan op 1,46. Als er ijsberg had gelegen had ik er 1,47 minimaal voor gehad.
  16. Debit or Credit 1 juni 2012 12:00
    quote:

    harrysnel schreef op 1 juni 2012 11:56:

    [...]

    Dat klopt niet, ik verkocht 10k. Merendeel (8488) is gegaan op 1,46. Als er ijsberg had gelegen had ik er 1,47 minimaal voor gehad.
    Je had ook een limiet op 1,50 of 1,47 moeten plaatsen. De particuliere belegger heeft toen inderdaad jou stukken deels op 1,46 over genomen! Wat was je reden tot verkoop harry?
  17. harrysnel 1 juni 2012 12:18
    @DOC: Reden voor verkoop is algemeen beurssentiment. Vaak wat latere reactie van lokale aandelen bij daling, wil dit plukje weer oppikken op lager niveau.

    Overigens gezien dat Agendia 50mln heeft opgehaald?
    www.iex.nl/Nieuws/ANP_ANP-310512-107/...
    Agendia wilde aanvankelijk naar beurs maar ging niet door vanwege slecht beursklimaat. Eerder heb ik op dit forum al geplaatst dat MDX-Health veel bestuurders kent afkomstig van Agendia. Ander raakvlak: Agendia heeft ook lab in Irvine, California. Sluit daarom samengaan niet uit. Misschien een reverse take-over van MDX-Health waardoor Agendia alsnog op beurs komt; Agendia heeft nu iig de financiele middelen.

    nb speculatie mijnerzijds
  18. Debit or Credit 1 juni 2012 12:25
    quote:

    harrysnel schreef op 1 juni 2012 12:18:

    @DOC: Reden voor verkoop is algemeen beurssentiment. Vaak wat latere reactie van lokale aandelen bij daling, wil dit plukje weer oppikken op lager niveau.

    Overigens gezien dat Agendia 50mln heeft opgehaald?
    www.iex.nl/Nieuws/ANP_ANP-310512-107/...
    Agendia wilde aanvankelijk naar beurs maar ging niet door vanwege slecht beursklimaat. Eerder heb ik op dit forum al geplaatst dat MDX-Health veel bestuurders kent afkomstig van Agendia. Ander raakvlak: Agendia heeft ook lab in Irvine, California. Sluit daarom samengaan niet uit. Misschien een reverse take-over van MDX-Health waardoor Agendia alsnog op beurs komt; Agendia heeft nu iig de financiele middelen.

    nb speculatie mijnerzijds
    Super post Harry! Zelf ben ik groot particulier belegger en investeer nu 8 maanden in mdxh, zelf een belang van ruim 200.000 aandelen in die tijd opgebouwd met een kleine verkoop van 18.500 aandelen kendrion a 18,80. Ik sluit niet uit dat Mdx ook overgenomen kan worden. Ik zie je graag terug volgens mij is je kennis zeker de moeite waard om te delen.

    Mvg,

    DoC.
  20. harrysnel 1 juni 2012 12:32
    Forum MDX is jammer genoeg niet zo actief maar kan natuurlijk veranderen. Dank voor de waardering:). Lees iig graag andere meningen over aandelen waar mijn interesse ligt. Juist lokale aandelen zijn m.i. de moeite waard, onbekend maakt soms onbemind en dan liggen er misschien kansen..
28 Posts
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