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MDxHealth nieuws 2014

5.395 Posts
Pagina: «« 1 ... 21 22 23 24 25 ... 270 »» | Laatste | Omlaag ↓
  6. forum rang 4 Nel 21 februari 2014 13:47
    Wat een onzin effegenoeg sorry dat ik even binnen kom vallen:-)
    DPA is de enige uitzenders die nog niks heeft gedaan de rest is ruim 100% gestegen op herstel
    Dus tja acherblijvers zullen eens een inhaalslag gaan maken:-) :-) :-)
    De investerders zoals doc zien dit ook in:-) :-) maar dat kan hij zelf beter toelichten
    Dus onzin wat je meld

    Succes hier
  7. [verwijderd] 22 februari 2014 19:38
    Heb een heel erg goed leesbaar stuk gevonden, wel van 11 Feb.

    A Test to Prevent Repeat Prostate Biopsies? Perhaps, if the Bar of “Clinical Utility” Can Be Met

    Published Online: February 11, 2014
    Mary K. Caffrey

    If a man who has symptoms of prostate cancer but a negative biopsy could use a test to avoid a second biopsy, wouldn’t that test make sense? It might, but it might not. The decision to pay for the test could rest on whether the man’s insurer, which often is Medicare, thinks his doctor will act based solely on the test’s outcome.

    This is the world of “clinical utility,” where in recent years, proving a test’s accuracy no longer pushes it past the finish line for payers.

    Recent efforts by MDxHealth, based in Hertsal, Belgium, and Irvine, California, to market its ConfirmMDx epigenetic test for prostate cancer—and to gather data to support broader availability— crystallize the competing forces at work in the molecular diagnostic marketplace, as clinical utility has emerged as the new bar for reimbursement.

    Why the change? It comes down to a single word: Cost.

    In the decade after the sequencing of the human genome, there’s been an explosion in personalized medicine, along with a rapid rise in new cost categories that didn’t exist just a few years ago.1

    A March 2012 white paper published by UnitedHealthcare said the payer spent $500 million on genetic and diagnostic testing in 2010, which represented 14% more per person than in 2008. Extrapolating on its own data, United Healthcare pegged the 2010 total for Medicaid and Medicare at $5 billion, or 8% of all national spending on clinical laboratory tests.2

    The concept of personalized medicine—matching the right drug to the right patient at the right time—holds out the promise of driving down costs over time, as therapies are used with precision, leaving less waste and fewer side effects. But for a test like ConfirmMDx to save money demands that physicians practice medicine differently, relying on a test instead of a second biopsy.3

    As new genetic and biomarker-based tests emerge, not all payers are convinced that physicians are ready for change. The bar of clinical utility requires test makers to prove that their diagnostic tool is the factor that drives decisions, not a belt-and-suspenders add-on that simply gives doctors more information.

    Therein lies the conundrum. Beth Davis, senior director of health policy and reimbursement for MDxHealth, said “clinical utility” means showing that a test has value to doctors in real-world settings. And proving that value can be difficult if payers won’t reimburse for the test, because that has the practical effect of making it unavailable to most patients.

    Clinical utility, Davis said, “is a big, evolving discussion right now, because it means different things to different people.” Essentially, she said, “You’re measuring physician behavior.”

    In the case of ConfirmMDx, the test maker is not only making the clinical argument that the test works, but also the economic argument that it saves money by preventing unnecessary second
    and third biopsies. Davis made her case December 4, 2013, at the Philadelphia meeting, Oral Oncolytics, including data that show 700,000 men have repeat biopsies annually because the standard 12-core method can miss a growing cancer3,4 (See Figure).

    Used in lieu of repeat biopsies, ConfirmMDx could save $588 per patient on average, or $500,000 a year for a commercial health plan with 1 million members, according to results published in
    American Health & Drug Benefits.5 The MDxHealth website has a growing list of commercial plans that reimburse for the test, and it continues to highlight results about the test’s validity.6,7

    An Economic and Quality of Life Case

    Prostate is the most common cancer among men, except for skin cancer; it is the leading cause of cancer deaths among men behind lung cancer. The American Cancer Society estimated that
    238,590 new cases would be diagnosed in 2013, with 29,720 deaths.8

    At the same time, the rise of cancer screening with the prostate-specific antigen (PSA) test over the past 20 years means that 2.5 million men who have had prostate cancer are alive today.8

    Widespread screening has saved lives but also increased costs and for some, complications. There is increased promotion of a “wait and watch” approach to those tumors that are not aggressive, and questions about the value of PSA testing led the US Preventive Services Task Force (USPSTF) to issue a highly controversial D rating for the popular screening.9 (See Panel Discussion).

    Since most prostate cancer diagnoses occur among older men, cost implications of large-scale PSA testing are huge. A study published just this month in Cancer tracked almost 95,000 men in Medicare, aged 66 to 99 years, who had never had prostate cancer, for 3 years.10 Just over half, or 51.2%, had PSA tests during the period, with 2.9% having a biopsy.10

    But as the Cancer article noted, 72% of the costs associated with PSA screening came from “downstream biopsy-related procedures,”10 and not from the screening itself; if those costs could be mitigated, discussion over the controversial D rating from the USPSTF might shift from how to not screen to how to limit the number of biopsies that result.

    ConfirmMDx still relies on biopsy as what Davis called the “gold standard,” but it recognizes that the standard 12- core method might miss cancerous tissue. ConfirmMDx seeks to confirm the presence of an epigenetic “halo” that exists around a tumor, which might be present even though the cells look normal under a microscope.

    The test relies upon DNA methylation, a biochemical process that can alter gene expression as cells divide and result in the silencing of tumor suppressors. When DNA methylation goes awry, unfolding either too quickly or too slowly, cancer can result. This process does not happen all at once; thus, DNA methylation can be used as a readout for a pre-cancerous or cancerous state.

    If a patient has a negative biopsy but a positive result with ConfirmMDx, the doctor can either treat as if the patient had a positive pathology result, or limit additional cores to the area of known “hot spots,” reducing costs, discomfort, and side effects, according to Davis. Thus, the ConfirmMDx test can not only limit costs but also improve quality of life.

    - See more at: www.ajmc.com/publications/evidence-ba...
  10. [verwijderd] 24 februari 2014 08:29
    Wederom een mooi bericht

    Published: 08:00 CET 24-02-2014 /GlobeNewswire /Source: MDxHealth (TM) /XBRU: MDXH /ISIN: BE0003844611

    ConfirmMDx for Prostate Cancer Test Featured in ONCOLOGY

    Review of New Biomarkers in Prostate Cancer



    IRVINE, CA, and HERSTAL, BELGIUM -- 8:00 AM, February 24, 2014 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 the ConfirmMDx® for Prostate Cancer test was highlighted as one of several key advances in biomarker technology that aims to transform detection of prostate cancer and its subsequent management. In a review published in the February 2014 issue of ONCOLOGY, leading urologists, E. David Crawford, MD, Neal D. Shore, MD and co-author Karen Ventii, PhD, explain how an explosion in genomic analysis and interpretation of prostate cancer tissue has enabled discovery of new biomarkers, their integration into clinical practice, and clinical management of the disease.



    Over 975,000 American men have 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 for undetected 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 detects an epigenetic field effect or 'halo' associated with the presence of cancer at the DNA level. This "halo" around a tumor can be detected in prostate cells despite 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.



    "In the last few years, several new genomic biomarkers have emerged that can help guide clinicians on when to biopsy, whom to re-biopsy, and how to assist patients in their treatment decisions," explained E. David Crawford, M.D, head of Urologic Oncology at the University of Colorado. "One such exciting test is ConfirmMDx for Prostate Cancer, an epigenetic assay to help distinguish patients who have a true-negative biopsy from those who may have occult cancer. This test aids in improved risk stratification and allows us to reduce unnecessary repeat biopsies on men at low risk for prostate cancer."



    "Prostate cancer biomarkers should assist the clinician in improving risk assessment, reducing overtreatment, and providing more selective therapy for patients with high-risk disease," noted Neal D. Shore, Medical Director of the Carolina Urologic Research Center, Myrtle Beach, South Carolina. "With new biomarkers like ConfirmMDx being integrated into the clinic, we are seeing clinical decision-making impact on patient care."



    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.

  15. peebee 24 februari 2014 13:20
    nog meer vuurwerk?
    MDXHealth is al aardig gestegen vind ik zelf, nu is iedereen in afwachting van de cijfers later deze week...ik kan me voorstellen dat degene die aandelen wil, deze nu wel in handen heeft.

    De rest (de snelle handelaren, daytraders) wachten eerst de cijfers af en kijken wat al die persberichten nu daadwerkelijk allemaal betekenen voor MDXHealth.

    Qua persberichten is er niets te klagen, nu maar kijken of de koers verder omhoog kan na de cijfers en de presentatie vanuit de directie.. ben zeer benieuwd of er ook een outlook gegeven wordt voor 2014, of dat het een "uitdagend" jaar wordt..
  16. [verwijderd] 24 februari 2014 13:34
    Hoezo aardig gestegen .
    In 5 jaar van ca 7 euro naar 3,68 . Terwijl de ontwikkelingen nu op zijn best zijn .
    Kijk je op KT , dan is er een leuke stijging voor degene die net op het juiste moment zijn ingestapt .Volgens mij staan we nog ,maar net aan het begin van een echte stijging ( zoals bijv Genfit /Horizon )

    Genfit in 1 jaar van ca 4 naar nu 31 euro .Dat is pas een stijging . Ook hier staan de ontwikkelingen nu op zijn best .

    Verkopen van MDX zullen nu maand op maand gaan versnellen .

  17. peebee 24 februari 2014 14:08
    als je zover terug kijkt moet je ook de verwatering in 2012 meenemen van ca 7 miljoen aandelen tegen een koers van 1,50 p/stuk geloof ik...die kwamen er toen ineens bij, dus koersvergelijking is niet zoals jij deze voorstelt.

    Vanaf (half) 2012, na de emissie is de koers al aanzienlijk gestegen.

    En inderdaad als je een van de eerste beleggers bent geweest is de oogsttijd aanstaande

    De aanhouder wint zullen we maar zeggen..
  18. [verwijderd] 24 februari 2014 15:22
    Hoeveel aandelen warrants ed zijn er inmiddels bij Genfit bijgekomen ? Ondanks dat stijging van inmiddels 900% in 1 jaar . Alles draait om resultaten / een topprodukt en verwachte verkopen .

    Ook MDx staat op het punt te expanderen . Daar hoort dan uiteraard een veel hogere koers bij .

    Ik vind het werkelijk ongelofelijk dat een Genfit bijv in 1 jaar met 900% kan stijgen .

    MDx mag het wat mij betreft met de helft doen .
  19. Debit or Credit 24 februari 2014 17:00
    quote:

    effegenoeg schreef op 21 februari 2014 13:33:

    [...]

    Hij heeft zich vol gekocht in dpa.
    Al zijn stops waren afgegaan en probeert nu zijn geluk in de uitzendbranch waar je volgens mij komend jaar effen niet wezen moet.
    Ben op vakantie, houdt alles prima bij alleen weinig tijd voor het forum.

    DoC.
5.395 Posts
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