MDxHealth nieuws 2014

1. Bio-marker 20 juni 2014 09:57

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   Na lang zoeken, hierbij wat meer info over de LCD. Het gaat maar om 1200 tests die vergoed worden. Lijkt alleen te gaan over Virginia, North and South Carolina. Er wordt niets gezegd over tests die al uitgevoerd zijn bij Medicare patienten.
   
   www.cms.gov/medicare-coverage-database
   
   Coverage Guidance
   
   Coverage Indications, Limitations, and/or Medical Necessity
   
   Indications and Limitations of Coverage
   Palmetto GBA will provide limited coverage for the ConfirmMDx epigenetic prostate cancer assay (MDxHealth, Irvine, CA) to reduce unnecessary repeat prostate biopsies. While no prospective evidence is currently available, preliminary retrospective evidence of clinical utility supports the potential value of this diagnostic test and serves as adequate evidence of likely clinical utility to support limited coverage. Palmetto GBA is aware that MDxHealth has initiated the PASCUAL Clinical Trial to prospectively address outcomes to establish clinical utility. Although limited coverage of this assay does support data collection within the PASCUAL trial, participation in the PASCUAL trial is not a prerequisite to the limited coverage. Coverage is limited to providers enrolled in the MDxHealth Certification and Training Registry (CTR) program. Based on the company’s proposed study scope, we expect approximately 1200 tests will be performed on Medicare patients performed in the 3 years from the effective date of the final LCD.
   
   ConfirmMDx assesses the methylation status of 3 biomarkers (GSTP1, RASSF1, APC) associated with prostate cancer. ConfirmMDx is intended for use in patients with high-risk factors such as elevated/rising prostate-specific antigen (PSA) or abnormal digital rectal examination (DRE), with a negative or non-malignant abnormal histopathology finding (e.g., atypical cell or high grade prostate intraepithelial neoplasia (HGPIN)) in the previous biopsy, and is being considered for repeat biopsy. Several case/control studies in archived biopsy core tissue blocks demonstrated the sensitivity, specificity and high negative predictive value (NPV) of these biomarkers to predict cancer detection in a repeat biopsy procedure. Single biopsy cores, using as little as 20 microns from formalin-fixed, paraffin embedded (FFPE) tissue blocks are used in this assay.
   
   The performance of this assay in a large, blinded clinical validation study demonstrated a NPV of 90% which is considerably higher than that afforded by standard histopathology review. A mathematically-based budget impact model using the assay in urologic practices to decide upon the need for repeat biopsies reported significant cost and medical resource savings by avoiding unnecessary, invasive biopsies over current standard of care methods. Further logistic regression models using all pertinent risk factors for prostate cancer detection (patient age, serum PSA level, digital rectal exam, histopathological findings on the previous cancer-negative biopsy and the assay) from the clinical validation trial were analyzed to compare various metrics separately and in combination. Assay results and prior histopathology were the strongest predictors of missed cancers and these two measures combined had a higher performance than either alone.
   
   The repeat biopsy rate for patients with an initial negative biopsy was reported to be approximately 40% in the Prostate, Lung, Ovarian and Lung (PLCO) screening trial suggesting that a majority of the patients undergoing repeat biopsies did not have cancer detected. A recently completed field observation study was conducted in 138 patients with negative biopsies and managed by the urologist receiving negative ConfirmMDx for Prostate Cancer assay findings from those patient’s tissues. Only 6 of the 138 patients in that series had received a repeat biopsy yielding a 4.5% repeat biopsy rate.
   
2. Bio-marker 20 juni 2014 09:57

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   ConfirmMDx is covered under the following conditions:
   
   1.Males aged 40 to 75 years old that have undergone a previous cancer-negative prostate biopsy within 15 months and are being considered for a repeat biopsy due to persistent or elevated cancer-risk factors
   and
   
   2.The previous negative prostate biopsy must have collected a minimum of 8 tissue cores (but not have received a saturation biopsy of > 24 tissue cores) and remaining FFPE tissue from all cores is available for testing
   and
   
   3.Minimum tissue volume criteria of 20 microns of prostate biopsy core tissue is available (40 microns preferable)
   and
   
   4.Previous biopsy histology does not include a prior diagnosis of prostate cancer or cellular atypia suspicious for cancer but the presence of high-grade prostatic intraepithelial neoplasia (HGPIN), proliferative inflammatory atrophy (PIA), or glandular inflammation
   and
   
   5.Patient is not being managed by active surveillance for low stage prostate cancer
   and
   
   6.Tissue was extracted using standard patterned biopsy core extraction (and not transurethral resection of the prostate (TURP))
   and
   
   7.Patient has not been previously tested by ConfirmMDx or similar molecular test
   and
   
   8.Testing has been ordered by a physician who is certified in the MolDx approved ConfirmMDx Certification and Training Registry (CTR) program
   
   Palmetto GBA expects MDxHealth to accrual patients in the PASCUAL trial and expects that roughly 50% will be for Medicare patients that are enrolled in the PASCUAL trial. Palmetto GBA expects that preliminary interim analysis of the PASCUAL trial results will become available 2 years from the beginning of the trial. If the interim analysis demonstrates a substantially lower re-biospy rate without adverse events, physician participation in the ConfirmMDx CTR program will be expanded, effectively increasing the number of patients tested and covered. If the interim analysis demonstrates poor patient accrual, suggesting limited merit of this assay in clinical practice, or fails to demonstrate a substantially decreased re-biopsy rate, limited coverage will continue until either 1200 patients have been tested or 3 years from the date of this LCD, which ever if first. Regardless of the final outcomes, when trial accrual is complete, Palmetto GBA expects peer-reviewed presentation and publication of the PASCUAL trial results. The trial results will be reviewed by Palmetto GBA in the context of a LCD reconsideration. Full coverage and removal of the CTR requirement are expected with favorable trial findings, or non-coverage for unfavorable findings.
   
   Certification and Training Registry (CTR) Program
   
   Because of the complicated nature of management decisions utilizing the ConfirmMDx assay and the potential for missing early prostate cancer, testing must be furnished only by physicians who are enrolled in the MolDx approved CTR program. The MDxHealth CTR program serves as a control to assure the appropriate selection of patients, compliance with management decisions and stringent follow up to ensure the benefits of the test outweigh its risks. As part of this requirement MDxHealth will provide to Palmetto GBA regular reports every 6 months.
   
3. Bio-marker 20 juni 2014 09:58

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   The goals of the ConfirmMDx Certification and Training Program are as follows:
   
   •To avoid missing clinically relevant early prostate cancers with associated increased morbidity and mortality,
   
   •To inform prescribers and patients on the safe-use conditions for ConfirmMDx,
   
   •To collect longer term outcomes.
   
   Palmetto GBA is aware that MDxHealth has initiated a confirmatory prospective trial (PASCUAL Clinical Trial) addressing the clinical utility and safety of ConfirmMDx. To assure safe use, MDxHealth will ensure that healthcare providers who order ConfirmMDx are registered and certified in the ConfirmMDx CTR program. ConfirmMDx testing is available only through these providers. The following criteria must be met in order for a healthcare provider to become certified:
   
   •Must have been trained and certified as being a registered investigator as part of the Confirm Mdx PASCUAL trial,
   
   •Must follow patients in a similar fashion to those enrolled in the PASCUAL trial,
   
   •Must provide and document patient counseling as to the benefits and risks of ConfirmMDx testing, highlighting the possibility of missing a clinically significant early prostate cancer,
   
   •Must collect and provide, on request to MDxHealth, a limited number of clinical data elements in patients where the test is ordered bu the patient is not a participant in a registry or trial where similar outcome data is being collected separately.
   
   Data Element Collection
   
   •General Elements:
   
   ?Total number of tests submitted to Medicare for payment
   
   ?Number of Medicare patients enrolled in ConfirmMDx clinical trial(s), and
   
   ?Number of Medicare tested patients, not enrolled in ConfirmMDx clinical trials
   
   •Patient Specific Elements:
   
   ?At initial testing:
   
   ?PSA and DRE findings
   
   ?Date of previous prostate biopsy(ies), with copies of pathology report preferred
   
   ?ConfirmMDx test results
   
   ?Every 6 months:
   
   ?Prostate re-biospy to include time (weeks/months) for previous negative biopsy, type of biopsy (transrectal vs transperitoneal),
   
   ?-Prostate cancer status (Y/N) to include Gleason score, stage, PSA at time of detection and treatment(s), when applicable
   
   ?-Deaths
   
   As part of the Certification and Training registry process, MDxHealth will:
   
   •Maintain a secure database of Confirm MDx CTR providers,
   
   •Monitor to ensure that only ConfirmMDx CTR providers are ordering ConfirmMDx testing.
   
   •Monitor use of the test for patients not enrolled in a clinical trial or outcome focused registry,
   
   •Institute corrective action and prevent a certified provider from ordering the tes if the provider is found to be non-compliant with the ConfirmMDx CTR program.
   
   MDxHealth will develop policies and procedures to provide Palmetto GBA with the required data elements. MDxHealth will also provide representative samples of educational materials, data collection forms, and reporting forms. The reportable data elements will be submitted to Palmetto GBA every 6 months in a mutually accepted format.
   
4. Bio-marker 20 juni 2014 09:58

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   Open Meetings/Part B MAC Contractor Advisory Committee (CAC) Meetings
   Meeting Date Meeting Type Meeting State(s) Meeting Information
   07/08/2014 Open Meeting South Carolina
   South Carolina
   Time: 9 a.m. to 11 a.m. EDT on July 8, 2014
   Location: Palmetto GBA, 17 Technology Circle, Columbia, SC 29203
   Conference Call #: 1-800-591-2259, Passcode: 201747
   
   Palmetto GBA J11 A/B Medicare Administrative Contractor (MAC) has scheduled Open Draft Local Coverage Determination (LCD) meetings in the following area in order to allow for the submission of information related to the proposed LCDs. The general public is invited to submit information for Palmetto GBA's consideration.
   
   LCDs are administrative and educational tools that assist providers, physicians and suppliers in submitting correct Medicare claims for coverage.
   
   07/08/2014 Carrier Advisory Committee (CAC) Meeting South Carolina
   Contractor Advisory Committee(CAC)
   07/10/2014 Open Meeting North Carolina
   North Carolina
   Time: 9 a.m. to 11 a.m. EDT on July 10, 2014
   Location: Hilton Garden Inn Charlotte North, 9315 Statesville Road, Charlotte, NC 28269
   Conference Call #: 1-800-591-2259, Passcode: 201747
   Palmetto GBA J11 A/B Medicare Administrative Contractor (MAC) has scheduled Open Draft Local Coverage Determination (LCD) meetings in the following area in order to allow for the submission of information related to the proposed LCDs. The general public is invited to submit information for Palmetto GBA's consideration.
   
   LCDs are administrative and educational tools that assist providers, physicians and suppliers in submitting correct Medicare claims for coverage.
   
   07/10/2014 Carrier Advisory Committee (CAC) Meeting North Carolina
   Contractor Advisory Committee(CAC)
   07/15/2014 Open Meeting West Virginia
   West Virginia
   Time: 9 a.m. to 11 a.m. EDT on July 15, 2014
   Location: Holiday Inn & Suites, 400 Second Avenue, Charleston, West Virginia 25303
   Conference Call #: 1-800-591-2259, Passcode: 201747
   Palmetto GBA J11 A/B Medicare Administrative Contractor (MAC) has scheduled Open Draft Local Coverage Determination (LCD) meetings in the following area in order to allow for the submission of information related to the proposed LCDs. The general public is invited to submit information for Palmetto GBA's consideration.
   
   LCDs are administrative and educational tools that assist providers, physicians and suppliers in submitting correct Medicare claims for coverage.
   
   07/15/2014 Carrier Advisory Committee (CAC) Meeting West Virginia
   Contractor Advisory Committee(CAC)
   07/17/2011 Open Meeting Virginia
   Virginia
   Time: 9 a.m. to 11 a.m. EDT on July 17, 2014
   Location: Doubletree by Hilton Richmond Airport, 5501 Eubank Road, Sandston, VA 23150
   Conference Call #: 1-800-591-2259, Passcode: 201747
   Palmetto GBA J11 A/B Medicare Administrative Contractor (MAC) has scheduled Open Draft Local Coverage Determination (LCD) meetings in the following area in order to allow for the submission of information related to the proposed LCDs. The general public is invited to submit information for Palmetto GBA's consideration.
   
   LCDs are administrative and educational tools that assist providers, physicians and suppliers in submitting correct Medicare claims for coverage.
   
   
   07/17/2014 Carrier Advisory Committee (CAC) Meeting Virginia
   Contractor Advisory Committee(CAC)
   Comment Period Start Date
   07/08/2014
   Comment Period End Date
   08/25/2014
   Released to Final LCD Date
   N/A
   Reason for Proposed LCD
   •New/Updated Technology
   Proposed Contact
   
   Elaine Jeter, MD
   PO Box 100190
   Columbia, SC 29202
   J11B.policy@PalmettoGBA.com
   
5. Bio-marker 20 juni 2014 10:07

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   Uit het jaarrapport:
   
   Inzake impact op de winst van unrecognized revenues:
   
   "Based on 2013 reported cases and historical average reimbursement amounts, the total estimated value of tests performed in 2013 was USD 9.3 million. Of this amount, the Company recognized USD 3.8 million, leaving uncollected outstanding unrecognized revenues of USD 5.4 million. This uncollected amount has been excluded from the Company’s 2013 revenues. Of the USD 5.4 million, USD 2.9 million is the estimated value of 2013 Medicare cases not recognized and USD 2.5 million unrecognized non-Medicare billings"
   
   Inzake risico van kapitaalverhoging:
   "Considering the situation, the Board of Directors believes that there is enough cash to sustain the current projects of the Company at least until the date of the annual general shareholders’ meeting scheduled for May 2015."
   
   Extra waarde van het bedrijf in geval van overname:
   "On December 31, 2013, the Company had net tax losses carried forward amounting to USD 146 million, implying a potential deferred tax asset of USD 50 million. Due to the uncertainty surrounding the Company’s ability to realize taxable profits in the near future, the Company did not recognize any deferred tax assets on its balance sheet."
6. [verwijderd] 20 juni 2014 12:03

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   quote:

   biostoxx schreef op 20 juni 2014 10:07:

   Extra waarde van het bedrijf in geval van overname:
   "On December 31, 2013, the Company had net tax losses carried forward amounting to USD 146 million, implying a potential deferred tax asset of USD 50 million. Due to the uncertainty surrounding the Company’s ability to realize taxable profits in the near future, the Company did not recognize any deferred tax assets on its balance sheet."
   

   Ik begrijp niet zo goed wat dit hierboven betekent. Wie kan het uitleggen? "Net Tax Losses"? Hoor het graag.
7. peebee 20 juni 2014 13:56

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   quote:

   cyborg1298 schreef op 20 juni 2014 12:03:

   [...]
   
   Ik begrijp niet zo goed wat dit hierboven betekent. Wie kan het uitleggen? "Net Tax Losses"? Hoor het graag.
   

   in Nederland heet dit: verliescompensatie.
   
   Bij de fiscus heb je dan kunnen regelen dat verliezen uit het verleden kunnen worden verrekend met toekomstige winsten.
8. vreemdvermogen 21 juni 2014 11:11

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   Exas olv Kevin Conroy staat goed in de picture:
   www.pharmiweb.com/pressreleases/press...
9. [verwijderd] 23 juni 2014 08:54

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   Vandaag: Buitengewone algemene vergadering. Als ik het me goed herinner wordt er besloten over optie pakketten voor personeel.
   
   Dit moet toch ook weer als indicator voor toekomstige koersstijgingen beschouwd worden? Wellicht eerst een downward reaction door mensen die niet op de hoogte zijn. Dit is natuurlijk al langer geleden aangekondigd.
10. peebee 23 juni 2014 08:59

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    quote:

    cyborg1298 schreef op 23 juni 2014 08:54:

    Vandaag: Buitengewone algemene vergadering. Als ik het me goed herinner wordt er besloten over optie pakketten voor personeel.
    
    Dit moet toch ook weer als indicator voor toekomstige koersstijgingen beschouwd worden? Wellicht eerst een downward reaction door mensen die niet op de hoogte zijn. Dit is natuurlijk al langer geleden aangekondigd.
    

    qua info heb je gelijk.
    
    qua indicator niet, lijkt me. opties voor personeel is natuurlijk zeer leuk, maar dat zijn er niet zoveel dat ze de beurskoers met procenten kunnen laten stijgen/dalen.
    
    Deze week moet het dan MDX week worden, mede gezien de bevestiging vanuit MDX dat de nieuwsbrief in jujni zou komen. Ik begrijp dat MDX op de bevestiging goedkeuring Exact zit te wachten, maar mij gaat het om de bevestiging van de omzet/resultaat 2014 uit autonome groei. Exact zie ik als een mooi extraatje.
11. [verwijderd] 23 juni 2014 09:22

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    Hi Peebee,
    Ik begrijp dat de opties op zich niet een reactie op de koers kunnen veroorzaken als de aantallen te laag zijn. Echter, er wordt aangekondigd dat MDX hiermee bezig is, dat doen ze alleen als het ook echt iets voor het personeel ( en zichzelf ) betekent. Ze verwachten dus dat de aandelen gaan stijgen, anders heeft het optieplan weinig inhoud.
12. peebee 23 juni 2014 09:35

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    daar heb je gelijk in cyborg..
    
    ze houden het geld dus liever aan boord...
    normaal gesproken bindt je de mensen via een optieplan aan het bedrijf en gaat er dus geen kennis verloren..dus ik vind het een goed plan.
    
    ben meer benieuwd of die nieuwsletter nog komt deze week!
13. [verwijderd] 23 juni 2014 09:44

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    Koers blijft laag dus ga nog eens bijkopen; ben wel benieuwd op welke prijs de opties mogen worden gaan uitgeoefend in a.s. optieplan
14. [verwijderd] 23 juni 2014 11:33

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    NEWS RELEASE
    Extraordinary General Shareholders’ Meeting
    IRVINE, CA, and HERSTAL, BELGIUM, 23 June 2014 –MDxHealth SA (NYSE
    Euronext: MDXH), a leading molecular diagnostic company that develops and
    commercializes epigenetic tests to support cancer treatment, held its Extraordinary
    General Meeting of shareholders in Zaventem today. The shareholders approved all
    agenda items of the Extraordinary General Meeting of shareholders.
15. peebee 24 juni 2014 10:28

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    nog steeds geen nieuwsbrief..
    
    als die vandaag niet openbaar gemaakt wordt, gaat er weer een mail naar MDX.
    één keer iets uitstellen kan ik begrijpen, maar 2x is not done en biedt niet echt vertrouwen aan mensen die in willen stappen...
    
    
16. [verwijderd] 24 juni 2014 11:22

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    quote:

    peebee schreef op 24 juni 2014 10:28:

    nog steeds geen nieuwsbrief..
    
    als die vandaag niet openbaar gemaakt wordt, gaat er weer een mail naar MDX.
    één keer iets uitstellen kan ik begrijpen, maar 2x is not done en biedt niet echt vertrouwen aan mensen die in willen stappen...
    
    

    Agreed!
    Sturen maar die email!
17. [verwijderd] 24 juni 2014 14:01

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    Al iets gehoord???
    Wat zou er in de nieuwsbrief zoal kunnen staan?
    Koers naar €6??
18. peebee 24 juni 2014 14:18

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    quote:

    DirkFrank schreef op 24 juni 2014 14:01:

    Al iets gehoord???
    Wat zou er in de nieuwsbrief zoal kunnen staan?
    Koers naar €6??
    

    vanavond gaat tie de deur uit, kreeg de vorige keren meteen de volgende dag respons, dus hopelijk ook deze keer.
    
    Inhoud nieuwsbrief:
    goedkeuring exact op Cologuard (met misschien nog data lancering produkt en percentage fee)
    outlook 2014 (zitten we nog op schema vwb omzet/resultaat)
    nieuwe produkten in de pijplijn, en waar staan deze nu?
    verwachtingen van directie voor 2014 (en volgend)
    cashflow (moet er nog geld bij middels emissie)
    
    we wachten verder...
19. [verwijderd] 24 juni 2014 14:37

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    Goed werk.
    Ben erg benieuwd naar hun reactie, het is een beetje lang stil van het front.
20. [verwijderd] 24 juni 2014 14:42

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    Zeker goed werk!
    Aan de koers te zien worden mensen wat ongeduldig...