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UrduOn 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.
Tag: american association for clinical chemistry
Families First Coronavirus Response Act Would Prohibit Insurers from Paying for Some COVID-19 Tests
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).
New Legislation Would Jeopardize Patient Access to Medical Tests Across the Board by Restricting Policy that Removed Barriers to Coronavirus Testing
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.
AACC Statement on New FDA Guidance That Allows Certified Labs to Perform Coronavirus Testing
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.
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
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.
Two New Rapid Coronavirus Tests Could Play Key Role in Efforts to Contain Growing Epidemic
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.
AACC CEO Janet B. Kreizman to Retire in the Second Quarter of 2020
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.
New AACC Guidance Document Outlines How Healthcare Professionals Can Prevent the Widespread Supplement Biotin From Interfering With Medical Tests
Biotin’s upsurge in popularity has led to a parallel rise in incidents of this health supplement interfering with critical medical tests. A new guidance document from AACC urges clinicians and laboratory experts to collaborate to prevent this potentially harmful test interference, and to ensure that patients taking biotin receive high quality care.
New Blood Test Could Help Elderly Concussion Patients With Internal Head Bleeding to Get Diagnosed, Treated Faster
Novel research shows that a blood test can differentiate elderly concussion patients with brain tissue damage from those without it. This finding, published in the special brain health collection of AACC’s The Journal of Applied Laboratory Medicine, could help ensure that elderly patients with severe concussions receive crucial treatment for their injuries.
Novel Research That Could Advance Testing, Treatment for Concussions Showcased in the January Issue of AACC’s The Journal of Applied Laboratory Medicine
In a special brain health collection, AACC’s The Journal of Applied Laboratory Medicine highlights the innovative clinical tests that laboratory medicine experts are developing to improve care for concussions.
Breaking Research in AACC’s Clinical Chemistry Journal Debunks the Claim That Vitamin D and Fish Oil Supplements Reduce Inflammation
One of the many advertised benefits of vitamin D and fish oil supplements is that they reduce systemic inflammation, which in turn could help prevent certain chronic illnesses. However, a first-of-its-kind study published in AACC’s journal Clinical Chemistry has discovered that these two supplements do not actually reduce inflammation in healthy individuals, a finding that could help consumers make more informed choices about which supplements they decide to take.
The Journal of Applied Laboratory Medicine Is Now Indexed in PubMed
AACC, a global scientific and medical professional organization dedicated to better health through laboratory medicine, is pleased to announce that its peer-reviewed publication The Journal of Applied Laboratory Medicine has been accepted for indexing in PubMed, one of the largest and most respected databases of medical research in the world.
AACC’s Journals, Clinical Chemistry and The Journal of Applied Laboratory Medicine, to Be Published through Oxford University Press
AACC, a global scientific and medical professional organization dedicated to better health through laboratory medicine, is pleased to announce a publishing partnership with Oxford University Press for its peer-reviewed journals, Clinical Chemistry and The Journal of Applied Laboratory Medicine. Both journals will join Oxford University Press’s world-class science portfolio starting in January 2020. The partnership will increase researchers’ and healthcare practitioners’ access worldwide to the important science published in the journals.