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2016 AACC

900 Seventh Street, NW
Suite 400
Washington,  DC  20001

United States
  • Booth: 2627

AACC is a global scientific and medical professional organization dedicated to clinical laboratory science and its application to healthcare. Our leadership in education, advocacy and collaboration helps lab professionals adapt to change and do what they do best: provide vital insight and guidance so patients get the care they need.


 Press Releases

  • FOR IMMEDIATE RELEASE 
    March 16, 2015 
    Molly Polen 
    AACC 
    Director of Communications & PR
    (p) 202.420.7612 
    (c) 703.598.0472 
    mpolen@aacc.org  

    WASHINGTON – Today AACC sent formal comments to the Food and Drug Administration (FDA) on the agency’s proposed regulation of next-generation sequencing tests. AACC appreciates FDA’s efforts to seek input from the healthcare community before developing new policy in this area, but is concerned that FDA regulation of next-generation sequencing could impede the advancement of precision medicine.

    Precision medicine uses a person’s unique biological makeup, including genetics, to determine which treatments that person would respond to best. Genetic tests hold the potential to predict an individual’s risk of developing numerous different conditions throughout life. Having this knowledge could lead one to take a more proactive approach to his or her health, particularly with respect to chronic diseases such as cardiovascular disease and diabetes that could be prevented with basic lifestyle changes. Next-generation sequencing will enhance the application of precision medicine by making genetic testing more readily available.

    After reviewing FDA’s preliminary discussion paper on the topic, “Optimizing FDA’s Regulatory Oversight of Next-Generation Sequencing Diagnostic Tests,” AACC recommends that oversight of next-generation sequencing remain under the Clinical Laboratory Improvement Amendments (CLIA) like other laboratory developed tests. CLIA-regulated laboratories conducting next-generation sequencing testing are experienced in developing, verifying, and performing clinical tests. AACC believes that CLIA-recognized accrediting bodies and professional societies should continue to take the lead in providing oversight and guidance for next-generation sequencing testing in the absence of specific, identified problems with this approach. 

    “AACC agrees with the FDA that next-generation sequencing tests offer great opportunities for advancing laboratory medicine and improving patient care, and we commend the agency’s efforts to initiate a dialogue among the various organizations and professionals involved in next-generation sequencing and those affected by such testing,” said AACC President Dr. David D. Koch. “We believe, however, that the current oversight mechanisms in place for next-generation sequencing are sufficient for dealing with the particular challenges this technology presents and that further FDA involvement at this time might hinder the advancement of this field.” 

     Read AACC’s comment letter here

    About AACC 
    Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org

     

     

  • FOR IMMEDIATE RELEASE
    January 14, 2015
    Molly Polen
    AACC
    Director of Communications & PR
    (p) 202.420.7612
    (c) 703.598.0472
    mpolen@aacc.org

    WASHINGTON – AACC is pleased to announce that Loretta L. Doan, PhD, has assumed the position of vice president of policy and global affairs effective today. Prior to joining AACC, Doan served as director of science policy at the Endocrine Society, an organization representing more than 18,000 scientists and clinicians. At the Endocrine Society, she led a diverse portfolio of science policy initiatives that advanced the field of endocrinology, including a program focused on the standardization of hormone assays.

    In her role at AACC, Doan will primarily be responsible for leading AACC’s science policy and advocacy efforts, which in 2014 involved issues ranging from funding for newborn screening to FDA’s proposal to regulate laboratory-developed tests. Doan will also work to build the association’s global presence and enhance the visibility of the field of laboratory medicine and its practitioners.

    “Dr. Doan has a unique skill set that combines strong scientific credentials with extensive experience in public policy and communicating scientific content and concepts to a range of audiences,” said AACC CEO Janet B. Kreizman. “With her proven ability to design and advance public policy initiatives, we are confident that she will be a strong asset in AACC’s effort to promote greater public understanding of lab tests, and to ensure that laboratory medicine professionals are heard when health and science policy issues are being addressed.”

    “It is a privilege to have been selected as AACC’s vice president of policy and global affairs,” said Doan. “I look forward to working with AACC staff and members, both in the U.S. and internationally, to build awareness of the essential contribution of laboratory medicine professionals to improving patient outcomes through effective lab testing, diagnosis, and treatment.”

    Background on Dr. Loretta L. Doan

    Doan joined the Endocrine Society in 2006 to serve as the organization’s manager of science policy, and launched the society’s first science policy program before being appointed associate director of science policy in 2008, and director of science policy in 2011. Prior to the Endocrine Society, Doan completed a 2-year post-doctoral fellowship in the Experimental Immunology Branch of the National Cancer Institute at the National Institutes of Health.

    Doan earned her PhD in biochemistry and molecular biology from the University of Louisville, Louisville, Kentucky, and holds two Bachelor of Arts degrees in chemistry and communications from Indiana University Southeast, New Albany, Indiana.


    About AACC
    Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.

  • FOR IMMEDIATE RELEASE
    January 29, 2015
    Molly Polen
    AACC
    Director of Communications & PR
    (p) 202.420.7612
    (c) 703.598.0472
    mpolen@aacc.org

    WASHINGTON – Today AACC sent formal comments to the Food and Drug Administration (FDA) addressing FDA’s proposal for oversight of laboratory developed tests. AACC shares FDA’s goal of improving the safety and effectiveness of these crucial tests, but recommends that the agency protect patient access to the tests by limiting its oversight to high risk laboratory developed tests. AACC additionally recommends that the agency broaden its criteria exempting tests for rare diseases from its review process, and re-evaluate its proposal to require the discontinuation or FDA review of tests that fulfill unmet clinical needs once the agency clears or approves a similar commercial test.

    There are many rare or new medical conditions for which no commercial test exists, and clinical laboratories have traditionally filled this void by creating medical tests in-house, known as laboratory developed tests. These tests fulfill a broad range of healthcare needs, from screening newborns for treatable genetic disorders to testing during the ongoing Ebola outbreak.

    Laboratory developed tests are currently regulated by the Centers for Medicare and Medicaid Services (CMS) through an oversight process that AACC believes is sufficiently rigorous. In recent years, however, the number and complexity of laboratory developed tests has increased dramatically, leading FDA in October 2014 to release draft guidance proposing that high- and moderate-risk laboratory developed tests should go through the agency’s clearance or approval process. Under the agency’s proposed oversight framework, low-risk laboratory developed tests would also be subject to registration and listing with the agency, as well as adverse-event reporting.

    After reviewing FDA’s draft guidance, AACC recommends that FDA limit its involvement with laboratory developed tests to joint oversight of the high-risk category with CMS. While FDA’s draft guidance does include plans to exempt certain tests for rare diseases from the review process, AACC believes the criteria for exemption are too narrow. If implemented, the FDA’s proposed criteria would exclude almost all newborn screening tests from the rare disease category. AACC is also concerned by FDA’s proposal to discontinue or review a test fulfilling unmet needs once a commercial test for the same condition is FDA-approved or cleared. This approach could stifle innovation and potentially diminish the quality of care given, because in many instances the laboratory developed test may be the more accurate test.

    AACC and FDA share the goal of optimizing outcomes for patients whose conditions warrant the use of laboratory developed tests. To this end, AACC strongly recommends that the agency’s approach include gathering data on the laboratory developed tests that labs currently use before making decisions regarding its planned oversight framework.    

    “There seems to be a misunderstanding that laboratory developed tests are unregulated because the FDA is only using its ‘enforcement discretion’ for them,” said AACC CEO Janet B. Kreizman. “Laboratory developed tests are actually subject to a variety of oversight mechanisms at the federal and state levels and by professional accreditation organizations. AACC is concerned that duplicative, costly federal oversight could result in many laboratories discontinuing these tests, and patients not getting the proper care because a commercial test does not exist to meet their needs.”

    Read AACC’s comment letter here.


    About AACC
    Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.

 

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