News

  • Facing Unprecedented Demand for Testing, Clinical Labs Ask Congress for Surge Capacity Fund

    March 19, 2020
    WASHINGTON, D.C. — As commercial laboratories rapidly extend considerable resources to meet demand for COVID-19 testing, ACLA President Julie Khani sent a letter to congressional leadership seeking support from the federal government. “We are growing increasingly concerned that the federal government is not recognizing the strain on the laboratory industry to meet the demand for testing for COVID-19,” writes Khani. As policymakers consider measuresContinue Reading »...
  • ACLA Letter to Congressional Leadership on COVID-19

    March 18, 2020
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  • LAB Act Co-Sponsors Letter to CMS

    March 18, 2020
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  • Statement on Recent FDA Actions To Expand COVID-19 Testing

    March 17, 2020
    WASHINGTON, D.C. – Following the FDA’s actions announced on March 16, ACLA President Julie Khani released the following statement: “The FDA’s guidance released on Saturday, February 29th cleared the regulatory hurdles to allow commercial labs to immediately begin testing patients as soon as test validation was complete, and our members began accepting specimens for testing less than a week later. The FDA has recently taken several positive steps toContinue Reading »...
  • Commercial Labs Step Up Capacity, Collaborate With Public Health Partners To Respond To National Emergency

    March 13, 2020
    Commercial capacity is expected to exceed 20,000 tests per day nationwide by end of next week, 280,000 tests per week by April 1. WASHINGTON, D.C. – Commercial laboratories have stepped up to bring critical COVID-19 testing capacity to the U.S. health care system. Following the FDA’s guidance on February 29 that provided an accelerated path for commercial laboratories to perform COVID-19 testing, commercial laboratoriesContinue Reading »...
  • COVID-19 Response Efforts: Role of Clinical Laboratories

    March 12, 2020
    Last Updated August 4, 2020 ACLA members have developed and validated novel COVID-19 tests and continue to scale up testing capacity. Members currently performing diagnostic tests for COVID-19 include Aculabs, Aegis Sciences, Ambry Genetics, ARUP, Biodesix, BioReference Laboratories, Exact Sciences, Inform Diagnostics, LabCorp, Mayo Clinic Laboratories, NeoGenomics Laboratories, Quest Diagnostics and Sonic Healthcare. Recent Updates Resource (July 31): Access To COVID-19 Testing Fact Sheet Blog (JulyContinue Reading »...
  • Commercial Labs Announce Plans to Provide COVID-19 Testing

    March 05, 2020
    WASHINGTON, D.C. – The FDA’s latest guidance released over the weekend provided an accelerated path for high-complexity laboratories to support additional testing capacity in response to the COVID-19 outbreak. Prior to Saturday’s announcement, ACLA members were already working to develop novel tests for COVID-19. Additionally, we have been in close communication with public health agencies since January as part of our existing memorandum of understanding with the CDC, the Association of PublicContinue Reading »...
  • ACLA Statement on the VALID Act of 2020

    March 05, 2020
    WASHINGTON, D.C. — Following the introduction of the Verifying Accurate Leading-edge IVCT Development Act of 2020, ACLA President Julie Khani issued the following statement: “ACLA and our member companies are focused on responding to the growing demand for COVID-19 testing capacity. In the coming days, ACLA will be reviewing the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020 with our members and engaging withContinue Reading »...
  • ACLA Statement on COVID-19 Testing

    March 04, 2020
    Following ongoing developments related to COVID-19 testing and response, included below is a statement from ACLA President Julie Khani following today’s meeting with the White House’s Coronavirus Task Force: “We appreciated the opportunity to meet with Vice President Pence and members of the White House’s Coronavirus Task Force this afternoon on the critical issues related to testing capacity. As an industry, clinical labs haveContinue Reading »...
  • ACLA Designates Annual Meeting “Handshake-Free”

    March 03, 2020
    WASHINGTON, D.C. — In light of recent concerns about the spread of COVID-19 in the United States, the American Clinical Laboratory Association (ACLA) is encouraging attendees to go handshake-free at Wednesday’s Annual Meeting. “As leading voices within the clinical laboratory diagnostics community, attendees recognize the importance of aligning our practices with the industry’s core commitment to public health, the driving force that brings usContinue Reading »...