American Clinical Laboratory Association

ACLA’s 2025 Annual Meeting brought together 200+ attendees for a day of political and policy insights from top public and private sector experts, including leaders from member laboratories, diagnostics manufacturers, and patient organizations. Learn more: https://bit.ly/3Xtqj5l

Clinical laboratory testing is essential for the early detection and effective treatment of diseases like diabetes, helping patients get timely care and improving health outcomes. Learn more about #ThePowerofKnowing: https://bit.ly/438URwY

Scheduled payment cuts jeopardize access to life-saving diagnostic tests that inform patients’ most important health care decisions. Tell Congress to #StopLabCuts: https://bit.ly/49QU2ZE.

Sexually transmitted infections (STIs) impact millions of Americans each year. Regular screening is vital for early diagnosis and treatment. Learn more about #ThePowerofKnowing this #STIAwarenessMonth: https://bit.ly/438URwY.

ACLA and its member company, HealthTrackRx, today announced a victory in its legal challenge to the FDA's Final Rule that would have regulated virtually all laboratory developed testing services as medical devices. The U.S. District Court for the Eastern District of Texas has vacated the Final Rule in its entirety, holding that FDA’s attempt to regulate professional laboratory testing services as medical devices exceeds the authority granted to FDA in the Food, Drug, and Cosmetic Act (FDCA). In an opinion that accepts many of ACLA’s primary arguments, the court found that “the text, structure, and history of the FDCA and [the Clinical Laboratory Improvement Amendments (CLIA)] make clear that FDA lacks the authority to regulate laboratory-developed test services.” The court emphasized that “devices” under the FDCA “are articles of commerce, not the kinds of services performed by doctors and laboratories,” and that Congress specifically addressed the regulation of clinical laboratories and their services through CLIA, an independent statutory framework. “The court’s ruling ensures that clinical laboratories can continue to focus on their primary mission – offering innovative and reliable diagnostics that save and improve the lives of millions of patients every day,” said ACLA President Susan Van Meter. “This is a victory that protects patient access to critically needed testing services and removes burdensome regulations that would have undermined the clinical laboratory system in this country.” Read our full statement here: http://bit.ly/41TbCuZ. 

#Multiplesclerosis can be detected and diagnosed early through clinical laboratory testing. These tests prevent delays in diagnosis, improving patient outcomes in the long run. Learn more about #ThePowerofKnowing this #AutoimmuneAwarenessMonth: https://bit.ly/438URwY.

Regular clinical laboratory testing is essential to reduce chronic kidney disease (CKD) and improve patient outcomes. Discover more about #ThePowerofKnowing this #NationalKidneyMonth: https://bit.ly/438URwY.

Unless Congress intervenes, clinical laboratories will face Medicare cuts, stifling investment in next-generation diagnostics. Congress must pass a long-term solution to #StopLabCuts: https://bit.ly/49QU2ZE.

DNA-based blood and fecal screening equip providers with the tools to detect colon cancer in early stages and provide patients the answers they need for their health care decisions. Discover #ThePowerofKnowing this #ColorectalCancerAwarenessMonth: https://bit.ly/438URwY.

Clinical laboratories are leading the way in diagnostic innovation, advancing timely health care for patients nationwide. Learn more about ACLA’s 2025 policy priorities: https://bit.ly/4h5GOMk.