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Home  /  Forum  /  MDxHealth  /  Kruipen richting de 2 euro

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Kruipen richting de 2 euro

84 Posts
Pagina: «« 1 2 3 4 5 »» | Laatste | Omlaag ↓
  18. [verwijderd] 12 april 2012 08:14
    social.eyeforpharma.com/opinion/perso...

    James Clark, vice-president for research and development at MDxHealth, based in Durham, North Carolina, described how DNA methylation patterns can be used as biomarkers for predicting cancer drug activity.

    One well-described example of this concerns temozolomide, a glioblastoma drug that has achieved blockbuster status.

    Patients with tumours in which the enzyme O6-methyl guanine methyltransferase (MGMT) has been deactivated by DNA methylation respond much better to this drug, with median overall survival improved by about nine months over similar patients without this methylation.

    It is now straightforward to detect DNA methylation patterns using second-generation sequencing techniques.

    MDxHealth is building a workflow to sequence 1,000 complete "reference epigenomes," which will be used to discover markers for cancers and other diseases, and modifying its technology so it can be used to test circulating DNA in readily accessible body fluids.

  19. Debit or Credit 17 april 2012 09:22
    Mdxhealth is donderdag aanwezig op dit event, zijn zij in staat om die dag de studie resultaten van het biopsy tissue te presenten? We gaan het zien! Ik verwacht dat we weer langzaam omhoog gaan naar nieuwe steunen en weerstanden. Dit event zal nieuwe investeerders werven. Wanneer kunnen we een eind maken aan het kruipen naar de 2 euro?

    Thursday 19 April 2012 - Register NowBioCapital Europe 2012, organised by LSP (Life Sciences Partners) and ABN AMRO, is delighted to announce its 10th consecutive event, taking place on Thursday 19 April 2012 in Amsterdam, The Netherlands.

    For the second year running, the event will be held at the luxurious and historic hotel Sofitel Amsterdam The Grand, the former town hall situated in the heart of Amsterdam.

    BioCapital Europe is Europe's premier life sciences investment conference, offering VCs and Institutional Investors unique and timely access to around 40 exciting biotech companies from the Benelux and Europe.

    Attendance is by invitation only. In 2011, the event attracted 200 attendees (mainly CEOs, CFOs, pharma execs, VCs, and Institutional Investors). VCs and Institutional Investors are invited to attend free of charge to this event.

    Met vriendelijke groet,

    DoC.
  20. [verwijderd] 17 april 2012 16:46


    Dear Shareholders,

    It is my pleasure to share with you the April 2012 progress report on MDxHealth. In this newsletter, I describe some of our recent accomplishments and the next steps in our strategy for future success. Below are a few of the highlights:

    In March, we released our fourth quarter and full year 2011 financial results. These figures showed a continued growth in our revenues, particularly in the fourth quarter, where we saw a 48% increase compared to the same period in 2010. This increase is attributable to the uptake of our epigenetic testing platform among the pharma industry. We anticipate future growth in our revenues throughout 2012 predominantly coming from companion diagnostic collaborations and sales of our ConfirmMDx™ for Prostate test after the launch later this year.

    Operationally, we continue to focus efforts on ensuring our new CLIA laboratory in Irvine is completely up to date. We finished the build out of our R&D facilities. The Irvine facility also received its out of state license from the State of Maryland, which allows the laboratory to receive and process clinical specimens from this state. All US laboratories are required to obtain licenses within their own state, as well as, five others: Maryland, Rhode Island, Pennsylvania, New York and Florida. We have submitted applications for all required out of state licenses and permits. In addition, the company hired four sales managers, one sales director and a director of marketing. These new personnel have many years of experience in the urology/oncology market and are now preparing for the launch of our prostate product in Q2 2012.

    As MDxHealth establishes its CLIA lab operations and initiates preparations for the launch of its ConfirmMDx for Prostate Cancer test, Miriam Reyes, VP of Lab Operations, provides below some interesting insights about the critical elements to run a CLIA lab.

    We appreciate your continued interest and support.

    Sincerely,
    Jan Groen


    As we implement our commercial strategy, we continue licensing discussions with the pharmaceutical and biotechnology industry for our epigenetic technology and tests. We are seeing greater acceptance of our approach as demonstrated by the increase in revenues. Recent publications in Nature (Nature 483, 637-639 (28 March 2012) and The Economist (Apr 7th 2012 ) clearly demonstrated that cancer epigenetics is one of the fasted growing fields. Many pharma companies are currently developing epigenetic based drugs.


    Miriam Reyes, VP of Laboratory Operations at MDxHealth
    Leading MDxHealth's CLIA laboratory build in preparation for the launch of ConfirmMDx for Prostate Cancer, Miriam Reyes provides below some interesting insights about the critical elements of running a CLIA lab.

    Beside the physical lab, what other departments are a crucial part of the lab ops?
    A CLIA lab has several integral departments that ensure the smooth running of operations, including Client Services, Logistics and Accessioning. A brief description of their roles is provided below:

    Client Services plays a crucial role in representing the company as one of the voices of MDxHealth. Client Services provides the customer service for our external and internal customers. For MDxHealth's existing and prospective customers, the department assists by providing testing information, test order status, logistical support, patient specimen test kit supply replenishment, billing support, as well as, acting as a conduit to the internal operations.

    The Logistics department coordinates the transportation delivery services and provides customer service reassurance of safe receipt and delivery of patient specimens and test results. The department tracks the patient specimen packages from the time they are picked up from our customer facilities to when they arrive at MDxHealth. The Logistics department also facilitates the timely delivery of patient reports to the customers and safely returns all patient specimen blocks that were used for the assay.

    The Accessioning department thoroughly reviews each patient case to ensure that the correct information and specimens were received. A reconciliation of patient specimens with the test requisition is performed on each case to confirm the patient test request. Every patient specimen is reviewed thoroughly, entered in the Laboratory Information Management System and barcode labelled for sample processing prior to submission into the laboratory. The accuracy of the information and specimens is crucial as it provides the initial identification of each patient specimen.

    Client Services plays a crucial role in developing and maintaining client relationships by being proactive and responsive to our client's needs.

    What is a LIMS system and how is it utilized?
    LIMS (Laboratory Information Management System) is a data management software program used in diagnostic laboratory settings for tracking and inventory of samples, reagents, and assay test results. In addition to laboratory functionalities, LIMS also includes patient, customer, and billing functionalities allowing for a fully integrated laboratory operations system. The system documents information ranging from account information, assay results, sample inventory, reporting and more in a centralized database, and provides a user interface to facilitate data management across all aspects of laboratory operations.

    What Quality Assurance Practices are implemented in a clinical laboratory?
    The laboratory has established, and follows, written policies and procedures as an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general, pre-analytical, analytical and post-analytical laboratory systems. Such defined quality metrics implemented in MDxHealth's laboratory operations involve the following: Assay Proficiency Testing, Personnel Competency, Qualification of Incoming Reagents, Equipment IQ/OQ/PQ, Bi-annual and Quarterly Equipment Calibrations, Monthly Assay Trending, Barcode labelling, Quarterly Quality Management Reviews and a Corrective Action and Preventative Action Program, all to meet quality value and customer satisfaction.

    Who is responsible to release the patient results?
    CLIA laboratories established and licensed in the State of California require a California licensed Clinical Laboratory Scientists (CLSs) to perform and release patient test results. After analysis, the CLS is responsible for the review of the quality control and patient data to determine if the patient test results can be released as an accurate and reliable result to the clinician. The end responsibility lies with the Laboratory Director that is a board certified pathologist with medical credentials and licenses in all of the five required states.

    How do doctors order the test?
    ConfirmMDx for Prostate Cancer may be ordered as a test through MDxHealth's test requisition form (TRF). On completing the TRF, clients follow the specimen requirements of the assay; whereby the client prepares, packages and ships the specimen directly to MDxHealth for sample processing. Customers will also have the option to order the assay through an online customer portal in the near future.



    Dr. Jan Groen, President and CEO of MDxHealth will be presenting at the following conferences:

    LSP Bio Capital Europe 2012
    April 19, 2012
    Amsterdam, The Netherlands
84 Posts
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