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Home  /  Forum  /  MDxHealth  /  MDxHealth nieuws 2014

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MDxHealth nieuws 2014

5.395 Posts
Pagina: «« 1 ... 168 169 170 171 172 ... 270 »» | Laatste | Omlaag ↓
  1. poolbeer 22 september 2014 20:23

    Exact Sciences Announces Group Health Cooperative as First Health Plan in Wisconsin to Cover Cologuard®

    Stool-based DNA (sDNA) screening test for colorectal cancer to be available by prescription to patients at Group Health Cooperative Clinics

    .

    Business Wire
    Exact Sciences Corp.
    5 hours ago

    MADISON, Wis.--(BUSINESS WIRE)-

    Exact Sciences Corp. (EXAS) today announced that Group Health Cooperative will be the first health plan in Wisconsin to offer Cologuard® to its patients. Cologuard is the first and only Food and Drug Administration (FDA) approved, noninvasive stool DNA screening test for colorectal cancer. Cologuard will be available to patients as part of their current laboratory benefits, covered by Group Health Cooperative of South Central Wisconsin (GHC-SCW), and can be prescribed by their primary care physicians.

    Cologuard offers people 50 years and older who are at average risk for colorectal cancer an easy to use screening test which they can do in the privacy of their own home. Cologuard has been proven to find 92 percent of colorectal cancers in average risk patients with 87 percent specificity. Unlike many other screening options, Cologuard does not require medication, dietary restrictions or bowel preparation prior to taking the test. It is the first noninvasive screening test for colorectal cancer that analyzes both stool-based DNA and blood biomarkers to detect cancer and precancer. The Cologuard technology platform was co-developed by Exact Sciences Corp. and the Mayo Clinic.

    “At Group Health Cooperative, we take pride in offering the most advanced cancer detection technology available,” said Kevin Hayden, Chief Executive Officer of Group Health Cooperative. “With colorectal cancer in particular, a high level of non-compliance with existing screening options has hampered our ability to identify the disease in its early stages when it is most treatable. As an accurate and patient-friendly screening option, Cologuard represents a significant advance in the fight against colorectal cancer. Making Cologuard available will hopefully encourage patients to get regular screenings and, in turn, improve survival rates for this preventable cancer.”

    Colorectal cancer is highly preventable with screening. However, twenty-three million Americans between 50 and 75 are not getting screened as recommended and, as a result, colorectal cancer remains the second-leading cancer killer in the United States. For those whose cancer is detected at an earlier stage, the five-year survival rate can be greater than 90 percent.

    “Exact Sciences is proud to be a Wisconsin-based company, making it especially fitting that one of the first health plans and clinics in the country to offer and cover Cologuard be in our own backyard,” said Kevin Conroy, president, CEO and chairman of Exact Sciences Corp. “We look forward to working with Group Health Cooperative to give patients in Wisconsin access to this important new cancer screening technology.”

    Cologuard is designed to detect DNA alternations and blood released from cancer and precancerous colon lesions. The test requires a physician order. After the physician orders Cologuard, the kit is mailed directly to the patient’s home. The patient then collects a stool sample in the Cologuard Collection Kit and sends the kit back to the Exact Sciences lab for testing through a pre-paid mailer. Patients learn of their results in as little as two weeks from their physician. Patients with a positive result will need to undergo colonoscopy.

    Cologuard will be available to patients through their current laboratory benefits, covered by Group Health Cooperative of South Central Wisconsin (GHC-SCW), through their primary care physicians. Rx only.

    For more information, visit www.CologuardTest.com or call 1-844-870-8870. More information on colon cancer and the importance of screening and early detection at www.beseengetscreened.com/. Visit www.exactsciences.com to sign up for the company’s eNewsletter.
  2. [verwijderd] 23 september 2014 08:15
    IRVINE, California, and HERSTAL, BELGIUM - September 23, 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 its ConfirmMDx® for Prostate Cancer test qualifies for Medicare coverage effective November 3, 2014.

    The Centers for Medicare and Medicaid Services (CMS) released the final version of the coverage policy issued by Palmetto GBA, the Medicare administrator responsible for the MolDx technology assessment program that evaluated the ConfirmMDx test:

    MolDX Title: ConfirmMDx Epigenetic Molecular Assay

    LCD#: L35368



    As part of an ongoing commitment to ensure that Medicare covers the appropriate use of the ConfirmMDx test, Palmetto GBA expects MDxHealth to continue accruing patients in the prospective, randomized PASCUAL clinical utility trial currently in process, and to enroll providers into it's Certification and Training Registry. The LCD provides for coverage initially limited to patients of physicians enrolled in the ConfirmMDx Registry. MDxHealth will conduct an interim analysis of the PASCUAL study to determine the repeat biopsy rate, and expects to complete the interim analysis in 2015. Provided the interim analysis yields positive results showing a substantially lower repeat biopsy rate, Palmetto will expand physician participation in the ConfirmMDx Registry, effectively increasing the number of Medicare patients covered. If the interim analysis demonstrates poor accrual, or fails to demonstrate a substantially decreased repeat biopsy rate, the LCD indicates that limited coverage will continue until either 1,200 patients have been tested or 3 years from the effective date of the LCD, which ever occurs first. MDxHealth expects to have tested 1,200 patients within the PASCUAL trial and the Registry by Q2 2016. Unrestricted Medicare coverage, with the Registry requirement removed, is expected with favorable PASCUAL trial findings.



    "The ConfirmMDx for Prostate Cancer test is an important tool validated to aid urologists with management of patients suspected to harbor undetected prostate cancer and the need for a repeat biopsy. The PASCUAL clinical trial is an opportunity to prospectively demonstrate how urologists utilize the test results in a patient population with a previous negative biopsy result," said principal study investigator Neal Shore, M.D. Medical Director, Carolina Urologic Research Center Partner, Atlantic Urology Clinics, Myrtle Beach, South Carolina. "Prostate cancer is one of the most common cancers in U.S., with 1 in 6 men diagnosed during their lifetime. Prostate cancer can be most effectively treated if caught early, so ConfirmMDx serves a vital role. The ConfirmMDx test provides valuable genomic insights beyond standard pathology review, helping urologists make informed decisions about the need for repeat biopsy on high risk patients."

    "We are pleased to announce this important milestone for the ConfirmMDx test, and MDxHealth. The decision by Palmetto GBA's MolDX technology assessment program to cover ConfirmMDx for Medicare beneficiaries under the conditions set forth in the LCD establishes ConfirmMDx as a "reasonable and necessary" test for the management of men suspected to have occult cancer. Medicare's decision will facilitate negotiations with private insurance companies as well," stated Dr. Jan Groen, CEO of MDxHealth. "Initial patient enrollment in the PASCUAL trial has been robust and we are confident this study will yield positive results corresponding to those already reported in the clinical utility study we published earlier this year
  5. [verwijderd] 23 september 2014 09:04
    In ieder geval mooie opening!

    Nu is het afwachten of het vastgehouden wordt en er meer kopers zijn of dat de marketmaker de koers kan blijven drukken onder de 4,10 en liefst onder de 4 euro.
    Hopen maar dat het nu eens doorzet. Er komt steeds iets meer PR.
    Het is afwachten tot de grote doorbraak doorzet, geduld misschien nog even.
  19. [verwijderd] 23 september 2014 10:02
    Ja het blijven kanzen want als we alles wisten dan was het niet zo moeilijk maar de kans omhoog lijkt me toch echt groter dan naar beneden. En ja ik zit er inmiddels zwaar in dus heb mijn roze brilleke op. En zoals eerder gezegd door ene Mark R. te D. is een zwarte piet nu eenmaal zwart
5.395 Posts
Pagina: «« 1 ... 168 169 170 171 172 ... 270 »» | Laatste |Omhoog ↑

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