FDA LDT Rule Overturned—Important Update for Your Lab

Important Regulatory Update:

On March 31, 2025, the U.S. District Court for the Eastern District of Texas vacated the FDA’s Final Rule concerning Laboratory Developed Tests (LDTs). This decision effectively removes FDA-imposed restrictions and reaffirms the oversight of LDTs under CLIA regulations managed by CMS.

What does this mean for your lab?

Continuing Use of Empire ASR and RUO Probes:
Laboratories may continue developing and validating Laboratory Developed Tests utilizing Empire Genomics’ ASR and RUO-labeled probes without FDA regulatory burden or additional premarket approval requirements.

Operational Clarity:
The uncertainty created by the FDA’s Final Rule has been resolved, allowing labs to confidently continue delivering critical diagnostic information without disruption.

Ongoing Commitment to Compliance and Quality:
Empire Genomics remains committed to providing high-quality, reliable FISH probes and reagents, supporting your laboratory’s clinical and research needs under existing CLIA standards.

Next Steps:

• No immediate action is required
• Continue utilizing Empire Genomics’ ASR and RUO products as your trusted FISH Vendor.
• Contact our team if you have specific regulatory or compliance-related questions.

Empire Genomics remains your trusted partner and first choice in FISH, committed to keeping you informed and ahead of regulatory changes.

Questions or concerns?
Reach out to your Empire representative or email us directly, we are here to help you!