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Released: 26-Mar-2020 10:40 AM EDT
AACC Applauds the Senate for Updating Its Legislation to Ensure that All Patients Have Access to COVID-19 Testing
American Association for Clinical Chemistry (AACC)

AACC applauds the U.S. Senate for responding to the concerns of the clinical laboratory community and revising the Coronavirus Aid, Relief, and Economic Security (CARES) Act to ensure that it provides insurance coverage for all COVID-19 tests, regardless of whether or not they are performed under an FDA emergency use authorization (EUA).

Released: 24-Mar-2020 11:30 AM EDT
When Mothers Receive Fentanyl Epidurals During Labor, the Fentanyl Gets Passed on to Their Babies
American Association for Clinical Chemistry (AACC)

Breaking research in AACC’s The Journal of Applied Laboratory Medicine shows that the fentanyl in epidurals can pass on to babies during labor. While the infants in this study did not experience adverse effects from this fentanyl transfer, this information is crucial to ensuring that new mothers don’t get falsely accused of fentanyl abuse, which can have dire social repercussions for mother and child.

Released: 19-Mar-2020 3:00 PM EDT
AACC Launches Directory of U.S. Labs That Are Performing COVID-19 Testing
American Association for Clinical Chemistry (AACC)

To facilitate rapid identification of COVID-19 cases, AACC has launched a directory of U.S. clinical laboratories that are, or will be, performing testing for SARS-CoV-2, the virus that causes COVID-19. This directory is designed to help healthcare providers quickly find laboratories that can diagnose patients suspected to have COVID-19.

Released: 17-Mar-2020 4:30 PM EDT
AACC Urges Congress to Ensure That All COVID-19 Tests Are Covered by Insurance Now That FDA Has Released Guidance That Will Expand Testing Access
American Association for Clinical Chemistry (AACC)

On March 16, FDA updated its guidance on COVID-19 testing to allow clinical labs to create and perform COVID-19 tests without pursuing FDA emergency use authorization (EUA). AACC commends this decision, which will help speed the expansion of COVID-19 testing at this crucial time. However, the association remains concerned that the Families First Coronavirus Response Act does not provide coverage for COVID-19 tests unless the tests are performed under an EUA. AACC urges Congress to rectify this problem before passing the bill so that all patients will have access to coronavirus testing.

Released: 16-Mar-2020 8:30 AM EDT
Families First Coronavirus Response Act Would Prohibit Insurers from Paying for Some COVID-19 Tests
American Association for Clinical Chemistry (AACC)

AACC greatly values the work that the U.S. House of Representatives has done to support American families in the midst of the coronavirus outbreak and is supportive of the goals of H.R. 6201, the Families First Coronavirus Response Act. However, we are concerned that the language as currently drafted does not provide coverage for COVID-19 tests performed prior to those tests receiving Emergency Use Authorization (EUA) from the Food & Drug Administration (FDA).

Released: 6-Mar-2020 3:55 PM EST
New Legislation Would Jeopardize Patient Access to Medical Tests Across the Board by Restricting Policy that Removed Barriers to Coronavirus Testing
American Association for Clinical Chemistry (AACC)

On March 5, U.S. House and Senate lawmakers introduced the VALID Act, which would give the Food and Drug Administration (FDA) new, expansive powers to regulate laboratory developed tests—tests that are already regulated by the Centers for Medicare and Medicaid Services (CMS) and are subject to stringent personnel, quality control, and proficiency testing requirements. This bill promotes duplicative, costly federal regulations for clinical laboratories that will result in decreased patient access to essential medical tests. AACC urges Congress not to act on this bill until its impact on healthcare can be thoroughly evaluated.

Released: 2-Mar-2020 10:45 AM EST
AACC Statement on New FDA Guidance That Allows Certified Labs to Perform Coronavirus Testing
American Association for Clinical Chemistry (AACC)

AACC thanks the FDA for being responsive to the concerns of the clinical laboratory community and amending the coronavirus guidance to allow CMS-certified labs to develop and implement new tests for coronavirus prior to FDA approval.

Released: 28-Feb-2020 2:30 PM EST
As U.S. Struggles to Get Coronavirus Testing Up and Running, AACC Calls on FDA to Allow Clinical Labs to Develop Their Own Tests for the Virus
American Association for Clinical Chemistry (AACC)

In a letter to the Food and Drug Administration (FDA), AACC is urging the agency to allow clinical laboratories to develop coronavirus tests without going through FDA review. Lifting this regulatory requirement is key to ensuring that all patients have access to high-quality coronavirus testing and that healthcare workers have the tools they need to control the spread of this disease in the U.S.

Released: 31-Jan-2020 5:50 PM EST
Two New Rapid Coronavirus Tests Could Play Key Role in Efforts to Contain Growing Epidemic
American Association for Clinical Chemistry (AACC)

Breaking research in AACC’s Clinical Chemistry journal shows that two new tests accurately diagnose coronavirus infection in about 1 hour. These tests could play a critical role in halting this deadly outbreak by enabling healthcare workers to isolate and treat patients much faster than is currently possible.

Released: 15-Jan-2020 2:40 PM EST
AACC CEO Janet B. Kreizman to Retire in the Second Quarter of 2020
American Association for Clinical Chemistry (AACC)

AACC today announced that its CEO, Janet B. Kreizman, will retire in the second quarter of 2020. “For the past 7 years, Janet has been a strategic leader for the organization, strengthening the association’s position as the leading voice and hub for laboratory medicine professionals dedicated to advancing quality patient care and improved health outcomes,” said AACC President Dr. Carmen L. Wiley.


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