FDA Changes to Laboratory Developed Test Regulation: Livestreamed Expert Panel
Association for Diagnostics & Laboratory Medicine (ADLM)FDA Changes to Laboratory Developed Test Regulation: Livestreamed Expert Panel - Live Event. 07/30/2024
FDA Changes to Laboratory Developed Test Regulation: Livestreamed Expert Panel - Live Event. 07/30/2024
A novel study published today in ADLM鈥檚 journal, Clinical Chemistry, has found that it takes the human body much longer than previously thought to clear xylazine 鈥 one of the most popular emerging drugs of abuse in the U.S. This much-needed insight into how the body processes xylazine could improve treatment of overdose patients who鈥檝e taken it.
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) released a position statement today supporting consumers鈥 efforts to play active roles in their healthcare by ordering their own laboratory tests. The statement emphasizes that such direct-to-consumer testing should be performed only by reputable laboratories that are certified under the Clinical Laboratory Improvement Amendments (CLIA) and that are committed to providing clear information and guidance to help consumers interpret the results.
Today, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC), together with the American Association of Bioanalysts, American Society for Clinical Pathology, American Society for Microbiology, and the Infectious Disease Society of America, has filed an amicus brief in the case of American Clinical Laboratory Association (ACLA), et al. v. U.S. Food and Drug Administration (FDA), et al.
Today, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) released the latest results from an ongoing survey that ADLM has been conducting to determine how the Food and Drug Administration鈥檚 (FDA鈥檚) final laboratory developed tests rule will impact patient care. The survey found that, under the FDA rule, individuals from rural and historically marginalized communities will have severely limited access to vital tests, which could lead to harmful and even life-threatening delays in diagnosis and treatment.
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) has issued expert guidance on lipid tests, which measure blood levels of fats and cholesterol to help assess a patient鈥檚 risk of heart disease and stroke. By giving clinicians and laboratory medicine professionals much-needed clarity on how to best use these tests, the new guidelines will ensure that more patients with cardiovascular disease get the treatment they need.
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC), welcomed thousands of laboratory experts to ADLM 2024 (formerly the AACC Annual Scientific Meeting & Clinical Lab Expo) from July 28-August 1. The meeting featured groundbreaking advances in diagnostic research and technology that exemplify the essential role that the field of laboratory medicine plays in patient care.
Exciting research at the frontier of artificial intelligence and data science in laboratory medicine was presented today at ADLM 2024 (formerly the AACC Annual Scientific Meeting & Clinical Lab Expo).
Today at ADLM 2024 (formerly the AACC Annual Scientific Meeting & Clinical Lab Expo), researchers will present data on a novel test that predicts whether Alzheimer鈥檚 patients are genetically predisposed to side effects from anti-amyloid drugs, a promising new class of Alzheimer鈥檚 therapeutics.
Breaking research shows that rates of cannabis use during pregnancy are far higher than previously thought, a finding that could improve efforts to identify pregnant cannabis users and inform them of potential risks.
In a new study, researchers have demonstrated that there is an insufficient basis for incorporating race in prenatal screening for birth defects. In a second, separate study, researchers have found that HIV-exposed uninfected children are at higher risk for health problems compared to uninfected, unexposed children.
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) is pleased to announce the recipients of its 2024 Top Corporate Supporter Award, a distinction given to companies and organizations that generously support the association through advertising, sponsorships, and exhibits.
At ADLM 2024 (formerly the AACC Annual Scientific Meeting & Clinical Lab Expo) in Chicago, more than 300 experts will present cutting-edge research and technology that will shape the future of laboratory medicine and improve patient care.
On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the so-called Chevron doctrine and reinforced that Congress and the courts are responsible for writing and interpreting laws, respectively, not federal agencies.
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) is pleased to announce that Paul Jannetto, PhD, DABCC, FADLM, MT(ASCP), has been elected to serve on the ADLM board of directors as president-elect starting in August 2024. Following this, he will serve successive terms as the association鈥檚 president from August 2025-July 2026 and as past president from August 2026-July 2027.
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) is pleased to announce that Representatives John Joyce, MD (R-Pa.), and Cathy McMorris Rodgers (R-Wash.) are the recipients of ADLM鈥檚 Outstanding Legislator Awards for the 118th Congress.
Today, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) released the results of a survey that ADLM conducted to determine how the Food and Drug Administration鈥檚 (FDA鈥檚) final laboratory developed tests rule will impact patient access to essential tests. The survey found that, in spite of certain tests being exempt from the rule, it will still force many laboratories, particularly those in hospitals, to discontinue critical tests, including those needed to identify prescription and illegal drug use.
A new study demonstrates that minimally invasive blood collection devices could increase the participation of people experiencing homelessness (PEH) in public health studies and clinical research.
The U.S. Food and Drug Administration (FDA) has long sparked controversy with its proposals to regulate laboratory developed tests (LDTs) as medical devices.