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Home  /   Forum   /   MDxHealth   /   2013

2013

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147 Posts
Pagina: «« 1 ... 3 4 5 6 7 8 »» | Laatste | Omlaag ↓
  1. [verwijderd] 19 april 2013 13:18
    Ik heb sinds kort ook weer aandelen gekocht, 1500 voor 2,11. Verwacht binnenkort weer een stijging. Ik merk dat de laatste tijd de bied altijd hoger is dan de laat, dus het is een kwestie van tijd voordat we weer gaan stijgen. Waarschijnlijk naar aanloop van de cijfers op 7 mei over het eerste kwartaal. De omzet zal wel weer aardig opgelopen zijn tov 1ste kwartaal 2012. Ben benieuwd!
  10. [verwijderd] 6 mei 2013 12:59
    Ik hoop het. Hoewel ik zelf aandelen heb van MdxHealth verwacht ik toch enigszins een emissie. deze zal wel rond de 2 euro liggen denk ik, aangezien het aandeel daar sinds oktober 2012 boven ligt. Ik baseer dit op de volgende mededeling van de CEO:

    For the fiscal year 2013, the Company expects strong revenue growth, and is expecting the majority of revenues to come from its ClinicalMDx products and services. In the course of 2013 the Company expects to receive Medicare coverage for its ConfirmMDx test. Operating expenses are expected to increase primarily from the expansion of sales and marketing efforts in the U.S. Accordingly, 2013 net loss and cash burn are expected to increase versus 2012, while R&D expenses are expected to be remain at current levels.

    Er zat eind 2012 ongeveer 11,1 miljoen in kas. Men verwacht een sterke groei van de inkomsten, maar misschien nog wel een grotere groei van de uitgaven. Als de inkomsten minder sterk groeien dan de uitgaven, dan is het voor een bedrijf belangrijk om genoeg geld in kas te hebben. Voor dit jaar hebben ze dat, maar vorig jaar plaatsten ze ook in juli 2012 een emissie, toen ze nog genoeg in kas hadden. Het ligt er heel sterk aan wat de inkomsten en uitgaven zijn. In kwartaal 4 waren de inkomsten 1,7 miljoen en uitgaven 3,4 miljoen, het dubbele. Ik ben benieuwd of ze morgen met cijfers komen waarin de inkomsten meer zijn gestegen dan de uitgaven. Als dat zo is met een positieve outlook, dan zullen we stijgen en is er misschien geen emissie nodig. Anders gaat men toch op safe spelen, want de outlook voor de lange termijn ziet er naar mijn mening prima uit!

  14. Superdude 7 mei 2013 08:14
    Revenue increases 51% over first quarter 2012

    IRVINE, CA, and LIEGE, BELGIUM - May 7, 2013 - MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today issued its business update for the quarter ended March 31, 2013.

    "In Q1 2013, we recorded considerable growth in the sales of our ConfirmMDxTM for Prostate Cancer test. At the time of this release, we have surpassed a key milestone of 1,500 ConfirmMDx tests sold this year, exceeding the total number of tests sold in 2012. We experienced an increased rate of adoption within the urology community, adding new clients and further establishing a solid base of repeat clients, with nearly 400 urologists ordering ConfirmMDx to date," said Dr. Jan Groen, CEO of MDxHealth. "We are extremely pleased with the growing momentum of our commercialization efforts, augmented by the recent expansion of the sales force and the publication of our clinical validation study in the Journal of Urology earlier this year. We believe the increased awareness of ConfirmMDx among urologists will result in continued adoption by the urology community and drive positive coverage decisions by payors."

    Q1 2013 Highlights

    During Q1 2013, adoption of the ConfirmMDx(TM) for Prostate Cancer test, launched in May 2012, continued to grow, as reflected in the significant increase in revenues during the period. Revenues in Q1 2013 increased 51% compared to the same period in 2012, with total revenues of €1.1 million. Reported revenue in Q1 2013 was obtained exclusively from commercial activities. As of March 31, 2013, the company had €9.5 million of cash on hand.

    In Q1 2013, MDxHealth published two prostate cancer scientific papers and presented two studies at the February ASCO Genitourinary Cancers symposium in Orlando, Florida, USA. Both the scientific publications and studies demonstrated that the biomarkers in the ConfirmMDx test outperform PSA in a prostate cancer detection algorithm and as an aide to the decision to proceed for a repeat prostate biopsy. The company also published a health economic study in the Journal of American Health & Drug Benefits, which demonstrates that a commercial insurance plan would realize approximately $600 in cost savings per patient within the first year of establishing coverage for the ConfirmMDx for Prostate Cancer test.

    During the quarter, Merck KGaA reported that its Phase III clinical study with cilengitide in newly diagnosed glioblastoma did not meet its primary endpoints. As a result the service agreement regarding MGMT testing for this particular project with Merck KGaA ended.

    Events after the Reporting Period

    On April 18, 2013, MDxHealth partner Exact Sciences reported top-Line data from the clinical trial of their Cologuard colorectal cancer screening test, a non-invasive, convenient DNA-based screening test for colorectal cancer and pre-cancerous polyps. Data from the 10,000-patient, DeeP-C clinical trial show that all endpoints were achieved, with sensitivity of 92% and specificity of 87% for the detection of colorectal cancer. Exact Sciences is expected to submit data from the DeeP-C study to the U.S. Food and Drug Administration as part of its pre-market approval (PMA) submission. Later this year, Exact Sciences is also expected to submit the study's complete data set for publication in a peer-reviewed journal, for presentation at a major medical meeting, or both. Exact Sciences intends to sell this test through its own CLIA service laboratory in Madison, Wisconsin. MDxHealth will receive milestone payments and royalties from the sale of the Cologuard test.

    In April, MDxHealth's Irvine-based CLIA certified and College of American Pathologists (CAP) accredited laboratory also received ISO 9001:2008 certification from DEKRA Certification, Inc., Chalfont, PA.

    Key non-audited financials, as of March 31, 2013

    Amounts in Euro's as at or for the three months ended


    Euro thousands

    March 31, 2013 YTD

    March 31,2012 YTD

    Revenues

    1,083

    719

    EBITDA Income (Loss)

    (2,838)

    (1,842)

    EBIT Operating Income (Loss)

    (2,906)

    (1,953)

    Net Profit (Loss)

    (2,905)

    (1,920)

    Cash and cash equivalents

    9,467

    9,557

    Q1 2013 commercial product and service revenue was €1.1 million, growing 51% over Q1 of 2012. None of the revenue was obtained from grants, compared to Q1 2012 which had €137K in revenue from grants. Overall spending in Q1 was €4.0 million, up €1.4 million over the same period last year. The increase in overall expense was primarily due to planned expansion of the company's commercial operations to accelerate the sales of the ConfirmMDx for Prostate Cancer test. First quarter operating loss (EBIT) and net loss were €2.9 million, an increased loss of €953K and €985K, respectively, over the same period in 2012. The Company's cash and cash equivalents as at March 31, 2013 was €9.5 million. The Company's revenue recognition policy at this time is primarily based on cash collections. Because reported revenues generally exclude uncollected outstanding billable cases, the impact of current test sales on reported revenues may be delayed by one or more calendar quarters. However, as billing and reimbursement trends are established with each payor, the Company is transitioning to an accrual-based revenue recognition policy. Additionally, MDxHealth has held claims to Medicare and will pursue payment once Medicare has reviewed and approved the company's medical dossier and finalizes reimbursement for the test, expected in 2013.

    Q2 and FY2013 Outlook

    MDxHealth will continue executing its commercialization strategy for the ConfirmMDx for Prostate Cancer test by establishing new sales and marketing agreements within and outside the U.S. Operating expenses are expected to increase primarily from this expansion of our commercial efforts in the U.S. The Company expects total revenue to grow significantly in Q2 over Q1 and to show year-over-year growth for FY2013. This guidance is based on management's assessment of growth, including anticipation of increased sales of the ConfirmMDx for Prostate Cancer test and from new PharmacoMDx opportunities. MDxHealth also expects to receive a license for its CLIA laboratory from the State of New York before the end of Q3, 2013.
  19. Superdude 8 mei 2013 09:32
    Press Release
    MDxHealth's ConfirmMDx(TM) Combined with PSA and Other Risk Factors, Improves Diagnosis of Prostate Cancer



    ConfirmMDx Highlighted in Presentation on New Biomarker Algorithm for Prostate Cancer at 2013 AUA Conference

    IRVINE, CA, and LIEGE, BELGIUM - 8:00 AM, May 8, 2013 - MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today announced that an integrated risk management approach combining epigenetic profiling using the ConfirmMDx for Prostate Cancer test, combined with PSA, histopathological findings and other risk factors, improves the detection of prostate cancer, stratifying men at high risk for prostate cancer from those at low risk who may forego a repeat biopsy. Data were presented at the American Urology Association annual meeting in San Diego, USA.

    The standard of care for screening has been PSA and DRE exam, however this has generated a great deal of controversy within the medical community. The American Urological Association supports use of PSA in the appropriate age group of men, despite the USPSTF recommendation to restrict its use. One of the biggest challenges with PSA screening is the high number of false-positive test results leading to prostate biopsies on men suspected to have prostate cancer. The majority of men will receive a negative biopsy result, however due to sampling errors, cancer can be missed in up to 25% of biopsied men. This leads to uncertainty of diagnosis and a high rate of repeat biopsies.

    "Results from clinical studies have demonstrated that the ConfirmMDx for Prostate Cancer test can help urologists confirm negative biopsy results, reducing the need for repeat biopsies, and ensure men with positive results are managed appropriately," explained Prof Wim van Criekinge, Head of the Laboratory for Computational Genomics and Bioinformatics (Biobix), University of Ghent, Belgium, who presented the data. "These studies show that integrating multiple traditional risk factors with this type of DNA methylation profiling increases the specificity of testing. Ultimately this could decrease the risk of misdiagnosis and improve patient management."

    Study Details
    Logistic regression models were used to evaluate a population of 391 men with a first, prostate cancer-negative biopsy with a complete panel of risk factors (age, PSA, digital rectal examination, histopathology and the epigenetic profile). All risk factors were tested individually and in combinations. The epigenetic profile was found to be the strongest individual predictor (odds ratio (OR) = 3.46; p-value < 0.001). The clinical utility was optimal for a model including the epigenetic profile and the histological findings of the first biopsy, resulting in a sensitivity of 74%, a specificity of 63% and an NPV of 91%.

    Clinical Update on Novel Prostate Cancer Biomarkers
    In a session at the AUA conference titled "Understanding How New Biomarkers Will Assist in the Diagnosis and Prognosis of Prostate Cancer", urology experts Dr. David Crawford and Dr. Neal Shore examined the clinical utility and current status of new prostate cancer biomarkers, such as MDxHealth's ConfirmMDx for Prostate Cancer and Genomic Health's Oncotype DX. The discussion described how these tests can aid in the improved detection and treatment of prostate cancer.

    The session provided an overview of the prostate cancer diagnostic pathway that included the role of biomarkers. In addition, a case study was presented that highlighted the urologist's dilemma when presented with a patient with elevated PSA and other high risk factors. MDxHealth's ConfirmMDx for Prostate Cancer was used to highlight how the significant issue of false-negative biopsies can be addressed.

    "When a prostate biopsy is performed for appropriate indications, there may be concern that the cancer may have been missed, despite the usual 10-14 core sampling. Tests which can improve the negative predictive value for a 1st time biopsy have clinically significant benefit, thus potentially avoiding unnecessary repeat biopsies," said Neal Shore, MD, FACS, CPI, Medical Director at the Carolina Urologic Research Center. "ConfirmMDx is a valuable addition to our armamentarium and addresses an unmet need in diagnostic evaluation. Many men are subjected to unnecessary repeat biopsies, with the attendant morbidity and cost, as a result of an elevated PSA as well as the concern of missing an undetected cancer. ConfirmMDx assists in the avoidance of unnecessary repeat biopsies."

    The program was supported by the Prostate Conditions Education Council, a consortium of leading physicians, health educators, scientists and prostate cancer advocates.

    About ConfirmMDx for Prostate Cancer
    Over 650,000 American men receive a negative prostate biopsy result each year; though approximately 25% of these men may still harbor occult prostate cancer. This well-documented risk of undetected cancer, often with clinically significant Gleason scores, leads to a high rate of repeat biopsies with over 40% of men receiving at least one repeat biopsy, and many receiving a 3rd and 4th biopsy. Today's gold standard diagnostic approach is the prostate biopsy procedure, collecting 10-12 needle core biopsy samples, however this sampling represents less than 1% of a man's prostate. ConfirmMDx for Prostate Cancer is an epigenetic assay to help urologists distinguish patients who have a true-negative biopsy from those at risk for occult cancer. The test is able to detect an epigenetic field effect or "halo" associated with the cancerization process at the DNA level. This molecular "halo" around a cancer lesion can be present despite having a normal appearance under the microscope. 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.

    About MDxHealth

    MDxHealth is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. The company's first commercial product, ConfirmMDxTM for Prostate Cancer, has been shown to help distinguish patients who have a true-negative biopsy from those who may have undetected cancer. MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. The company has a proprietary platform and a strong epigenetic product pipeline focused on the development of products for prostate, brain and lung cancers. The company is based in Irvine, California with a European headquarters in Liege, Belgium. For more information visit MDxHealth's website at www.mdxhealth.com and follow us on Twitter at: www.twitter.com/mdxhealth
  20. Superdude 10 mei 2013 13:32
    MDxHealth kijkt uit naar Amerikaanse licentie
    Vrijdag 10 mei 2013

    Het farmabedrijf MDxHealth uit Luik, gespecialiseerd in moleculaire diagnostiek, heeft tijdens het eerste kwartaal van dit jaar een omzet gerealiseerd van 1,08 miljoen euro. Dat betekent een stijging met 51 procent tegenover dezelfde periode vorig jaar. Het nettoverlies nam toe van 1,9 miljoen euro tot 2,9 miljoen euro.
    Hogere kosten

    Het verlies moet volgens het bedrijf worden geweten aan de toenemende kosten. Het bedrijf voegt er aan toe te verwachten dat de omzet tijdens het tweede kwartaal verder zal stijgen, maar er wordt aan toegevoegd dat ook de marketing-kosten, vooral voor prostaatkanker-tests op de Amerikaanse markt, verder zullen blijven toenemen. Er wordt wel opgemerkt dat voor het einde van het derde kwartaal op een licentie voor een laboratorium voor kankertests in de Verenigde Staten wordt gehoopt, waardoor het bedrijf naar eigen zeggen toegang krijgt tot een zeer aantrekkelijke commerciële markt.

    Bron: Express.be
147 Posts
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