HealthTrackRx Applauds Court Ruling to Vacate FDA's Laboratory-Developed Test (LDT) Rule

DENTON, Texas, April 1, 2025 /PRNewswire/ -- HealthTrackRx, a leader in molecular diagnostics and named plaintiff in the lawsuit challenging the U.S. Food and Drug Administration's (FDA) regulation of laboratory-developed tests (LDTs) as medical devices, applauds the U.S. District Court for the Eastern District of Texas for summarily vacating the FDA's Rule. This decision is a major victory for clinical laboratories, healthcare providers, and most importantly, patients.

"This ruling affirms what we and our colleagues across the industry have long maintained: the FDA lacks the legal authority to regulate LDTs," said Martin Price, Executive Chairman & CEO of HealthTrackRx. "By vacating this rule, the court has protected patient access to vital diagnostic testing, ensured continued innovation in laboratory medicine, and prevented unnecessary regulatory burdens that would have resulted in increased healthcare costs and delayed critical diagnoses."

Preserving Patient Access to Essential Testing

HealthTrackRx, alongside the American Clinical Laboratory Association (ACLA), challenged the FDA's rule imposing significant additional regulatory requirements on LDTs. The rule threatened access to specialized, high-quality testing crucial for diagnosing and managing infectious diseases, genetic conditions, and other complex health concerns.

Laboratory-developed tests have driven major diagnostic advancements—from early cancer detection to rapid infectious disease testing. The court's decision prevents unnecessary costs and delays, ensuring patients and providers continue receiving timely, accurate results.

"Our ability to develop and rapidly deploy innovative diagnostic tests is essential to public health," said Price. "This ruling allows us to continue delivering the next-morning results that healthcare providers rely on to make informed treatment decisions without unnecessary regulatory hurdles."

Commitment to High-Quality, CLIA-Regulated Testing

HealthTrackRx remains committed to rigorous quality standards under the Clinical Laboratory Improvement Amendments (CLIA) and believes laboratory oversight should remain with Centers for Medicare & Medicaid Services (CMS) rather than the FDA. Each of HealthTrackRx's laboratory facilities are accredited by the College of American Pathology (CAP), the widely recognized gold-standard for clinical quality and safety.

To learn more about HealthTrackRx and its mission to get people healthier faster, visit www.healthtrackrx.com.

About HealthTrackRx

HealthTrackRx is the nation's premier infectious disease laboratory delivering next-morning results through its advanced PCR-based testing solutions. Committed to "Getting People Healthier Faster," the company partners with healthcare providers nationwide to improve patient outcomes, reduce total care costs, and promote better stewardship of antibiotics. For more information, please visit https://www.healthtrackrx.com.

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SOURCE HealthTrackRx