October 2025 | Endo Lab & Medical Systems
Clinical Lab Newsletter
Innovation, Regulation, and Strategic Trends in Molecular
Testing & Remnant Sample Research
1) FDA Rescinds LDT Rule; Emergency IVD Guidance Finalized
FDA has officially rescinded the 2024 LDT rule after a March court decision. CLIA remains the governing framework. In parallel, FDA finalized guidance on enforcement discretion for IVDs during future EUA emergencies.
Takeaway: Keep your LDT inventory validated under CLIA and update your emergency testing SOPs to reflect the new guidance. Let us know if we can help with validation or just guidance. Contact: John Castelino @ john.castelino@endogroupllc.com
2) Respiratory Season Outlook: Low Now, But Prepare
CDC reports respiratory illness is currently low across the U.S., with influenza and RSV still at baseline. COVID-19 ED visits are declining but remain elevated. Meanwhile, AMA retired PLA codes 0240U/0241U—use CPT 87636/87637 instead.
Takeaway: Prepare for an October–November uptick. Update charge masters and payer policies to avoid claim denials. Let ENDO know if we can help with molecular test panels to increase throughput. Contact: John Castelino @ john.castelino@endogroupllc.com
3) Biospecimen Remnant Collection – Compliance Essentials
For research, de-identified specimens may not require IRB review under the Common Rule. HIPAA requires Safe Harbor or Expert Determination de-identification.
Takeaway: Align BAAs, MTAs, de-identification documentation, and audit trails now to support compliant remnant programs. If you want or need to know more, contact David Curley @ david.curley@endogroupllc.com
4) First FDA-Cleared Alzheimer’s Blood Test
FDA cleared the Lumipulse G pTau217/β-Amyloid 1-42 plasma ratio as the first Alzheimer’s disease blood test (for adults 55+ with symptoms).
Takeaway: Labs with Lumipulse analyzers can expand diagnostics now. Monitor CLFS updates and payer coverage over the next 6–12 months.
5) CLIA Updates You Shouldn’t Miss
Paperless CLIA is coming: CMS will stop mailing paper fee coupons & certificates after March 1, 2026.
Personnel & PT changes: New requirements are live as of Jan 1, 2025.
Takeaway: Confirm your email notification settings, update personnel records, and check PT enrollment against the new criteria.
Upcoming Industry Events (Fall 2025)
Pathology Visions 2025 (DPA) — Oct 5–7, San Diego, CA
AMP 2025 Annual Meeting — Nov 11–15, Boston, MA
ASCP 2025 Annual Meeting — Nov 17–20, Atlanta, GA
MEDICA 2025 — Düsseldorf, Germany | Nov 17–20, 2025
October Fun Fact
A single microliter of human blood contains around 4–6 million red blood cells—millions of oxygen couriers in a droplet smaller than a grain of sand.
Have questions, ideas, or want to feature your lab in next month’s edition?
Reply to this email or contact us at info@endolabsystems.com.
Stay smart, stay compliant.
