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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. In response to this landmark decision, Representative Bill Cassidy, MD (R-La.), sent a letter to the Food and Drug Administration (FDA) today asking how the agency plans to implement this new framework, especially considering the fact that, under this new ruling, many of the agency’s actions in recent years are now officially considered to be outside the bounds of its authority.

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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’s president from August 2025-July 2026 and as past president from August 2026-July 2027. In addition, the ADLM membership elected two new directors to the association’s board. They will take office in August 2024 along with the incoming president of the Academy of Diagnostics & Laboratory Medicine and the incoming chair of the ADLM Clinical Laboratory Scientists Council, both of whom will also serve on the board.

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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’s Outstanding Legislator Awards for the 118th Congress.

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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’s (FDA’s) 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.

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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.

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The U.S. Food and Drug Administration (FDA) has long sparked controversy with its proposals to regulate laboratory developed tests (LDTs) as medical devices.

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Breaking research demonstrates that clinical labs should account for the self-reported race of pregnant individuals when screening for spina bifida and other open neural tube defects. This finding, which was presented today in the Association for Diagnostics & Laboratory Medicine’s (formerly AACC’s) Clinical Chemistry journal, could improve prenatal care for pregnant Black individuals.

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To this day, no one knows for certain what caused the liver and kidney disease that led to Ludwig van Beethoven’s untimely death. However, a new letter to the editor in the Association for Diagnostics & Laboratory Medicine’s (ADLM’s, formerly AACC’s) journal Clinical Chemistry rules out one popular theory, showing that the composer was exposed to lead levels that were high — but not high enough to kill him.

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The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) has issued a new guidance document that provides expert recommendations on fundamental areas of clinical testing for respiratory viral infections. As respiratory virus testing continues to evolve rapidly in the wake of the COVID-19 pandemic, this guidance aims to ensure that patients benefit fully from emerging technologies in this field.

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We at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) strongly disagree with the Food and Drug Administration’s (FDA’s) decision to issue a final rule placing laboratory developed tests under duplicative FDA authority, in addition to these tests’ current regulation under the Centers for Medicare & Medicaid Services (CMS).

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The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) is proud to announce the recipients of the 2024 ADLM and Academy of Diagnostics & Laboratory Medicine Awards. Through this annual awards program, ADLM and its Academy recognize individuals around the world for outstanding research and service in the field of laboratory medicine and highlight the vital contributions made by all lab professionals to patient care.

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Today, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) released the results of a survey the organization conducted to determine how the Food and Drug Administration’s (FDA’s) proposed laboratory developed tests rule would impact patient care.

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Statement attributable to: Octavia Peck Palmer, PhD President, Association for Diagnostics & Laboratory Medicine (formerly AACC)

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“Today, we at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) provided testimony to Congress regarding the impact of the Food and Drug Administration’s (FDA’s) proposed rule to impose FDA oversight on laboratory developed tests in addition to Centers for Medicare & Medicaid Services (CMS) oversight. While we share FDA’s goal of ensuring that laboratory developed tests are safe and effective, we have serious concerns about the agency’s proposal. If finalized, this rule would create a burdensome dual regulatory structure that would limit patient access to many life-saving tests.

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A new tuberculosis (TB) test disclosed in the Association for Diagnostics & Laboratory Medicine’s (formerly AACC’s) Clinical Chemistry journal would allow testing for TB treatment monitoring to occur outside of a biosafety level 3 (BSL-3) laboratory.

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“We at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) were surprised to see a statement from Drs. Jeff Shuren and Dora Hughes from the Centers for Medicare & Medicaid Services (CMS) in support of the U.S. Food & Drug Administration’s (FDA’s) proposed rule to duplicate the regulation of laboratory developed tests by placing these tests under FDA authority, in addition to their current regulation under CMS.

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A new study shows that lapatinib, a drug used for the treatment of metastatic HER2-positive cancer, is associated with improved overall survival in patients with initially HER2-negative metastatic breast cancer and HER2-positive circulating tumor cells (CTCs).

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The Association for Diagnostics & Laboratory Medicine’s (formerly AACC’s) Clinical Chemistry journal released a special issue today titled “Cancer: Biology and Diagnostics,” which presents a wide range of discoveries with the potential to improve cancer diagnosis and treatment.

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Molecular diagnostics is a powerful branch of laboratory medicine that examines the fundamental genetic and biochemical components of life to provide invaluable insights into health and disease.

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A special report published today in the Association for Diagnostics & Laboratory Medicine’s (ADLM’s, formerly AACC’s) The Journal of Applied Laboratory Medicine describes the design, operations, and methodology of the COVID Immunity Study, a large-scale scientific study by ADLM that took place in September 2021.