News

  • Comments Regarding Proposed NIH Genetic Test Registry

    July 29, 2010
    Re: Request for Information on the National Institutes of Health Plan to Develop a Genetic Testing Registry Dear Dr. Collins: On behalf of the American Clinical Laboratory Association (ACLA), I am pleased to submit these comments on the proposed National Institutes of Health (NIH) Genetic Test Registry (GTR). ACLA represents national, regional, and local laboratories across the country, many of which offer extensive menusContinue Reading »...
  • Clinical Laboratory Industry on Role for FDA in Regulating Laboratory Developed Tests

    July 16, 2010
    July 16, 2010 For Immediate Release Contacts: Alan Mertz, 202-637-9466; amertz@clinical-labs.org David Mongillo, 202-637-9466; dmongillo@clinical-labs.org Clinical Laboratory Industry on Role for FDA in Regulating Laboratory Developed Tests “21st Century tests require 21st Century Solutions” Washington, DC — The Food and Drug Administration can promote progress toward personalized medicine by approaching the oversight of laboratory developed tests (LDTs) in a focused, flexible, and balanced wayContinue Reading »...
  • The Genome Project: A Balance Sheet

    June 15, 2010
    To the Editor: Mapping the human genome was not just about finding cures. It was also about understanding disease so we could provide better care. That is now happening in spades throughout the health system. Genetic tests can identify the exact molecular nature of a patient or disease, allowing for better prevention and targeted treatment. The cure rate for childhood leukemia now exceeds 80Continue Reading »...
  • Comments on NPI Interim Final Rule

    June 07, 2010
    Acting Administrator Marilyn Tavenner Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201   RE: Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (CMS-6010-IFC) Dear Acting Administrator Tavenner: On behalf of the American Clinical LaboratoryContinue Reading »...
  • ACLA Supports Physician Guidance in Patient-Centered Genetic Testing

    May 12, 2010
    Washington DC – Consumers should seek the guidance of a personal physician or other health care provider in the use of direct to consumer genetic tests to ensure proper understanding of the results and appropriate follow-up, said the American Clinical Laboratory Association (ACLA) today. Recent media reports of genetic tests being marketed and sold directly to consumers in drug stores and other retail establishmentsContinue Reading »...
  • Letter to Health Level Seven on Electronic Delivery of a Laboratory Directory of Services (eDOS)

    May 06, 2010
    Dr. Charles Jaffe, M.D., Ph.D. Health Level Seven, International 3300 Washtenaw Avenue, Suite 227 Ann Arbor, MI 48104 RE: American Clinical Laboratory Association Laboratory Test Compendium Framework Dear Dr. Jaffe: The American Clinical Laboratory Association (ACLA) represents national, regional, and local laboratories that collectively have an extensive history of providing the nation’s hospitals and physicians with leading-edge health information technology (IT) to streamline theContinue Reading »...
  • Comments on Device Tax and LDTs

    February 28, 2010
    See Original PDF here. February 28, 2010 Internal Revenue Service 1111 Constitution Avenue, NW Washington, DC 20224 Re: Notice 2010-89 Dear Ladies and Gentlemen: The American Clinical Laboratory Association (ACLA), is pleased to provide these comments regarding implementation of the excise tax on medical devices in new Section 4191 of the Internal Revenue Code (the ―Code‖), as added by Section 1405 of the HealthContinue Reading »...
  • Comments on the President’s Council of Advisors on Science and Technology (PCAST) Report

    January 19, 2010
    Department of Health and Human Services Office of the National Coordinator for Health Information Technology Attention: Steven Posnack Hubert H. Humphrey Building, Suite 729D 200 Independence Avenue, SW Washington, DC 20201 Re: Request for Information Regarding the President’s Council of Advisors on Science and Technology (PCAST) Report Entitled “Realizing the Full Potential of Health Information Technology To Improve Healthcare for Americans: The Path Forward”Continue Reading »...