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MDxHealth Nieuws 2017

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  1. maurice 1971 29 oktober 2017 12:55
    Heb een interssant artikel gelezen in een tijdschrift over MDX.
    Had graag in het kort wat info hier over sta te popelen om in te stappen

    Mvg
    Maurice
  2. forum rang 6 Tom3 29 oktober 2017 13:25
    quote:

    maurice 1971 schreef op 29 oktober 2017 12:55:

    Heb een interssant artikel gelezen in een tijdschrift over MDX.
    Had graag in het kort wat info hier over sta te popelen om in te stappen

    Mvg
    Maurice
    Aan leesvoer hier geen gebrek zou ik zo denken. Er zijn ook tegengeluiden van bijvoorbeeld een J2000 en DWBH, maar die hebben onderweg om een of andere reden de bibbers gekregen. Blijft boeiende lectuur. Denk niet dat JG uiteindelijk zal falen in het nakomen van zijn targets. Indien hij het waarmaakt ga je heel andere koersen zien
  3. forum rang 6 Tom3 29 oktober 2017 17:54
    Hier het hele artikel over mri/prostaatkanker in Medscape:
    NCI Study: MRI of the Prostate Misses Cancers

    Roxanne Nelson, BSN, RN
    October 27, 2017
    The use of multiparametric (MP) MRI has improved the detection of clinically important prostate cancers and has cut down on the detection of indolent cancers.
    However, new findings from a study involving 100 consecutive men with prostate cancer who were treated at a major imaging center show that a substantial number of cancers are missed.
    About 16% of lesions were missed, and approximately 5% of clinically important prostate cancers (>5 mm, Gleason score > 3+3) were underestimated on MP MRI, according to Baris Turkbey, MD, of the Molecular Imaging Program at the National Cancer Institute in Bethesda, Maryland, and colleagues.
    Overall, prostate cancer size was underestimated by at least 30% in eight (8%) of 100 patients.
    Their study was published online October 20 in Radiology.
    Use of advanced MRI for patients with prostate cancer is being increasingly studied, as it holds promise for detecting potentially aggressive prostate tumors as well as possibly sparing some men from having to undergo invasive biopsies. Last year, the first study of MRI as a primary prostate cancer screening tool reported that its use was "feasible" for the general population.
    The authors of the current study note that although MP MRI has been validated in a number of studies, the modality fails to detect some clinically important cancers.
    "It is widely quoted that the 'miss rate' on MRI for clinically significant tumors is between 10% and 20%," said Dr Turkbey. "Our study showed comparable results."
    The purpose of this study was to illustrate cases of MRI-negative prostate cancer to show that, even on technically good MRI imaging studies from an experienced site, MRI is imperfect, he explained.
    "It misses some tumors, and it underestimates others. On balance, however, MRI has consistently been shown to be of a net benefit, as it shows 30% to 40% more clinically significant lesions than random biopsies."
    It's very similar to the situation with mammograms. Dr Baris Turkbey
    Therefore, MRI is a very useful adjunct in prostate cancer diagnosis, but it is not 100% accurate. "Patients need to understand that ? and that it's very similar to the situation with mammograms," Dr Turkbey said.
    High Detection Rate, but False Negatives Occur

    In this study, Dr Turkbey and his colleagues sought to identify and characterize false negative, clinically important prostate cancers that were missed during MP MRI assessment in a retrospective, single-center study.
    The cohort consisted of men who had undergone MP MRI and subsequent radical prostatectomy, which allowed for a definitive analysis of their cancerous lesions. The men's imaging studies were prospectively interpreted by two genitourinary radiologists who were blinded to the histopathologic findings.
    Two other readers, who were not blinded to the histopathologic findings, assigned a Prostate Imaging Reporting and Data System (PI-RADS) version 2 score to each clinically important lesion (0.5 mm; Gleason score, 3+3) that was missed on MP MRI.
    A total of 162 clinically important lesions were included in the final analysis. The duration between MRI and prostatectomy was 128 days (median, 120 days; range, 2 - 390 days).
    At least one clinically important cancer was detected at initial MRI interpretation in 99 patients (99%). In one individual (aged 59 years; prostate-specific antigen [PSA] level, 3.75 ng/mL; PSA density, 0.045 ng/ml2), all lesions were missed on MRI. At least one clinically important lesion was missed in 26 (26%) of the cohort, and the size of clinically important cancers was underestimated in eight (8%) patients.
  4. forum rang 6 Tom3 29 oktober 2017 17:55
    Taken together, 136/162 lesions (84.0%) were correctly identified by MRI.
    Eight lesions (4.9%) were prospectively identified, but tumor size was underestimated on MRI (Gleason score, 3+4; n = 5 [3.1%]; Gleason score, 4+4; n = 2 [1.2%]; Gleason score, 4+5; n = 1 [0.6%]).
    A total of 26 (16%) lesions were missed during the initial interpretation (one per patient). Gleason scores in this patient subset were 3+4 (n = 17 [65%]), 4+3 (n = 1 [4%]), 4+4 (n = 7 [27%]), and 4+5 (n = 1 [4%]).
    During the retrospective review, eight (31%) PI-RADS 1 lesions were not detected on MP MRI; 18 (69%) lesions were visible (PI-RADS 2, n = 7 [27%]; PI-RADS 3, n = 6 [23%]; PIRADS 4, n = 5 [20%]). Within this group, five (62%) were Gleason 3+4 lesions, and three (38%) were Gleason 4+4 lesions.
    "We think that we can detect about half of the missed lesions and reduce the number of greatly underestimated lesions using computer-aided diagnosis algorithms," Dr Turkbey pointed out. "However, a number of patients will escape detection of their clinically significant prostate cancer using MRI alone. Therefore, we and many other centers continue to advocate for systematic biopsies in addition to targeted biopsies, and we are investigating several aspects of this phenomenon."
    Only 16 Patients Underweent MP-MRI Before Biopsy: What That Means

    Commenting on the study, Hashim U. Ahmed, PhD, BM, chair of urology and consultant urologic surgeon at Imperial College, London, United Kingdom, pointed out that all the patients in this series had biopsy-proven cancer.
    "The patients had identifiable cancer already, and as the authors show, 99 of the 100 men had one clinically significant cancer lesion correctly identified by MRI," Dr Ahmed said. "So, for the individual, there is a large probability of MP MRI identifying a significant cancer."
    He explained that it is already known that MP MRI has a miss rate for significant disease. In a clinical trial conducted earlier this year by Dr Ahmed and his colleagues, MP MRI administered as a triage test before the first transrectal ultrasound biopsy identified at least one quarter of all patients who could safety avoid undergoing a biopsy. Results of this study also suggested that this technology might improve the detection of clinically significant prostate cancer.
    "If one uses template mapping biopsies, as we did in the multicenter, prospective, blinded, validation PROMIS study of 11 expert and nonexpert centers, no cancers of Gleason 4+3 or higher of any volume were missed by MP MRI," he said. "This is already leaps and bounds better than the current transrectal systematic biopsy."
    This is already leaps and bounds better than the current transrectal systematic biopsy. Dr Hashim Ahmed
    Dr Ahmed did note that the current study did have some methodologic problems.
    "Only 16 of 100 were true prebiopsy MP MRI," he told Medscape Medical News. "We have known for over a decade that postbiopsy MRI scans are significantly degraded with biopsy-related inflammation and bleeding for between 3 and 6 months after a biopsy, and in some cases, up to 9 to 12 months. The study also only evaluated the two largest lesions on the report ? if there were significant MRI lesions after this upper limit of two, it seems the authors denoted them as 'negative' on the MP MRI."
    In explaining another concerning factor, he said, "We also need to be cognizant of the fact that MP MRI will not be the sole source of cancer localization and extent. Did the biopsies detect significant disease just outside and adjacent to the MRI lesion and in other areas? We don't know this.
    "We do know from a number of other studies, and this study confirms this, that MP MRI can underestimate the volume of the lesion on pathology," Dr Ahmed continued. "This information needs to be incorporated into targeted biopsy strategies and into treatment strategies, such as dose-escalation radiotherapy or focal ablative therapy."
    The authors have disclosed no relevant financial relationships. Dr Ahmed has received funding from Sonacare Medical, Sophiris, and Trod Medical for clinical trials.
    Radiology. Published online October 20, 2017. Abstract
    For more news, join us on Facebook and Twitter
    Medscape Medical News © 2017
  5. forum rang 6 Tom3 29 oktober 2017 18:21
    Even inhakend op het artikel gevonden door de tuinman: bij de Andros mannenkliniek vindt het klinisch onderzoek plaats dmv een mp mri en de SelectMDxH test. Als alle 2 negatief zijn vind er geen verder onderzoek plaats. Bij een positieve test bij 1 of 2 van deze onderzoeken vind een biopsie plaats. De kans dat er dan een false negative bij zit (de bestaansreden van Confirm MDxH) zal minder groot meer zijn dan als er alleen een biopsie wordt uitgevoerd. In Europa is er kennelijk weinig bestaansrecht voor de Confirm test. Aangezien Amerikanen kennelijk voor driedubbele zekerheid gaan zal de Confirm test ook met een mri scan het nog wel even volhouden nu ook de mri steken laat vallen.
  6. forum rang 4 DWB Happy 30 oktober 2017 00:17
    quote:

    Tom3 schreef op 29 oktober 2017 18:21:

    Even inhakend op het artikel gevonden door de tuinman: bij de Andros mannenkliniek vindt het klinisch onderzoek plaats dmv een mp mri en de SelectMDxH test. Als alle 2 negatief zijn vind er geen verder onderzoek plaats. Bij een positieve test bij 1 of 2 van deze onderzoeken vind een biopsie plaats. De kans dat er dan een false negative bij zit (de bestaansreden van Confirm MDxH) zal minder groot meer zijn dan als er alleen een biopsie wordt uitgevoerd. In Europa is er kennelijk weinig bestaansrecht voor de Confirm test. Aangezien Amerikanen kennelijk voor driedubbele zekerheid gaan zal de Confirm test ook met een mri scan het nog wel even volhouden nu ook de mri steken laat vallen.
    Nee, de onlangs vernieuwde MRI scan die nu uitgerold gaat worden laat juist helemaal geen steken meer vallen, en is juist een regelrechte bedreiging voor MDX.

    www.radboudumc.nl/nieuws/2017/binnen-...

    MDxHealth zit in een benarde situatie, er komt steeds meer concurrentie op de markt, urologen bepalen waarvoor ze kiezen $$.
    MDxHealth loopt achter de feiten aan, ze worden ingehaald door betere testen en onderzoeksmethodes.

    De zorgverzekeraar heeft de vernieuwde diagnostiek opgenomen in het zorginkoopbeleid en zal de verdere uitrol ervan in Nederland actief gaan stimuleren.

  7. forum rang 4 vreemdvermogen 30 oktober 2017 07:06
    MDxhealth Enters into Distribution Agreement with Unilabs for SelectMDx for Prostate Cancer

    NEWS RELEASE / REGULATED INFORMATION / INSIDE INFORMATION



    IRVINE, CA, and HERSTAL, BELGIUM - 07:00 CEST, October 30, 2017 - MDxHealth SA (Euronext: MDXH.BR) today announced that the company has entered into an agency service agreement for SelectMDx® with Swiss-based Unilabs, one of Europe's leading providers of clinical laboratory testing and medical diagnostic imaging services.



    Under the terms of the agreement, Unilabs medical laboratory in Geneva Switzerland, will perform SelectMDx service testing for all its clinical labs in France, Portugal, Sweden, Norway, Denmark, Finland, UK, Italy and Switzerland. To offer this service through its network, the laboratory will purchase SelectMDx CE-marked IVD kits from MDxHealth.



    "We are excited that Unilabs is going to offer SelectMDx service testing to their customers," said Dr. Jan Groen, CEO, MDxHealth. "The company's broad hospital network and commercial capabilities will significantly contribute to the successful market penetration of SelectMDx."

    "We are delighted to offer SelectMDx to Unilabs customers," commented Dr Pierre-Alain Menoud, Head of Molecular Diagnostics at Unilabs, Switzerland. "This agreement with MDxHealth reinforces our commitment to providing urologists with a service test."

  8. Jopie81 30 oktober 2017 08:15
    With more than 200 laboratories and 44 imaging units and a broad catalogue of more than 2,500 diagnostic tests, Unilabs is a leading European provider of clinical laboratory testing and medical diagnostic imaging services. Headquartered in Geneva, Switzerland the Unilabs Group serves private and public healthcare providers, local governments, pharmaceutical companies and the general public. The company employs more than 7,300 people worldwide, successfully operates laboratory and medical diagnostic imaging facilities in 15 countries, and generates annual revenues of €810m in 2016.
  9. [verwijderd] 30 oktober 2017 08:18
    Voila nog wat geduld , en als er geen algemene beurscrash komt , of een geopoletiek probleem , dan zit het wel goed met dit aandeel :)
  10. forum rang 4 vreemdvermogen 30 oktober 2017 08:34
    Bedenk wel dat het alleen een service is die ze bieden. Daar moet MDx wel voor betalen.Het belangrijkste is nu dat die testen afgenomen worden. De hele logistiek is op orde.
  11. forum rang 6 Tom3 30 oktober 2017 08:34
    quote:

    Jopie81 schreef op 30 oktober 2017 08:30:

    Vandaar dus dat ze zo'n haast hebben gemaakt met het open van het lab in Nijmegen.
    Dat lab in Nijmegen is alleen voor de Benelux landen. Duitsland, waar Unilabs niet zit, wordt bediend door Dr Stein & Kollegen
  12. forum rang 6 Tom3 30 oktober 2017 08:48
    quote:

    DWB Happy schreef op 30 oktober 2017 00:17:

    [...]

    Nee, de onlangs vernieuwde MRI scan die nu uitgerold gaat worden laat juist helemaal geen steken meer vallen, en is juist een regelrechte bedreiging voor MDX.

    www.radboudumc.nl/nieuws/2017/binnen-...

    MDxHealth zit in een benarde situatie, er komt steeds meer concurrentie op de markt, urologen bepalen waarvoor ze kiezen $$.
    MDxHealth loopt achter de feiten aan, ze worden ingehaald door betere testen en onderzoeksmethodes.

    De zorgverzekeraar heeft de vernieuwde diagnostiek opgenomen in het zorginkoopbeleid en zal de verdere uitrol ervan in Nederland actief gaan stimuleren.


    Bij het Radboudmc wordt net als in het artikel van de tuinman ook gesproken over mp-mri. Ik zou dat artikel nog maar eens goed doorlezen. Mp mri geeft dus een lagere betrouwbaarheid dan SelectMDx. Enfin het is je eigen geld.

    www.radboudumc.nl/nieuws/2017/binnen-...
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