September 2025 | Endo Lab & Medical Systems – Clinical Lab Newsletter
Innovation, Regulation, and Strategic Trends in Molecular Testing & Remnant Sample Research
1) Respiratory Season 2025–26: Labs on High Alert
What’s on the horizon: The CDC anticipates a fall–winter 2025–26 respiratory season that may rival or slightly exceed last year’s peaks. Several viruses are already lining up:
Influenza: The 2024–25 season produced ~47 million illnesses, 610,000 hospitalizations, and nearly 27,000 deaths.
RSV: With new FDA-cleared vaccines (Arexvy, Abrysvo, Mresvia), labs may see shifts in disease severity and positivity rates.
Rhinovirus: Expected seasonal rise as schools and cooler weather drive indoor crowding.
Human Metapneumovirus (hMPV): Surges seen in China in late 2024 suggest greater visibility this year thanks to broader diagnostics.
Why it matters for labs & remnant programs:
Multiplex respiratory panels (influenza, RSV, hMPV, rhinovirus, SARS-CoV-2) will be in high demand.
Remnant collections from pre-, peak-, and post-season phases offer valuable temporal data.
Vaccine uptake, particularly for RSV, may reshape testing volumes and outcomes.
If you are interested in learning more about our respiratory panels and custom panels please email: john.castelino@endogroupllc.com
If interested in learning more about how your lab would benefit from our respiratory remnant collection contact: david.curley@endogroupllc.com
2) LDT Rule Vacated: FDA Oversight of LDTs Set Aside (for now)
On March 31, 2025, a federal court vacated the FDA’s LDT rule, concluding FDA lacks authority to regulate LDTs as “devices.” FDA did not appeal. Labs remain under CLIA and state law, but FDA or Congress may revisit oversight.
Action items: Ensure CLIA compliance, review personnel and validation requirements, and monitor FDA/CMS updates.
Contact us to discuss our comprehensive line of molecular panels and custom panels to optimize your offering. email: john.castelino@endogroupllc.com
3) First FDA-Cleared Alzheimer’s Blood Test
FDA cleared Fujirebio’s Lumipulse G pTau217/β-Amyloid 1-42 plasma ratio (May 2025), the first blood test aiding Alzheimer’s diagnosis. Quest and Labcorp have begun offering it.
Why it matters:
Action items: Standardize plasma workflows; align with payer policy and CPT/PLA coding.
Are you a lab that offers this testing? If so, please contact us about future blood clinical trials. email: david.curley@endogroupllc.com
4) H5N1 2025: Practical Guidance for Clinical & Molecular Labs
CDC reports sporadic H5N1 cases in cattle-exposed workers and ongoing herd detections. Risk to the public is low, with no sustained human transmission.
Lab implications:
Action items: Update specimen routing SOPs; ensure PPE and packaging meet CDC guidelines.
To learn more about our H1N1panel offerings contact John Castelino @ john.castelino@endogroupllc.com
Bonus: Multi-omics Tailwind
NIH’s All of Us program expanded to >415,000 WGS records in 2025 and is layering metabolomics.
Illumina launched Protein Prep, a proteomics workflow designed to integrate with NGS.
Implication: Link remnant collections with phenotypic data to maximize multi-omic research potential.
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
ADLM 2025 recordings available Sept 9
SEPTEMBER Fun Fact
Roughly 14 billion lab tests are performed in the U.S. each year across ~266,000 CLIA-certified labs—making labs the most productive factories of knowledge in medicine.
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.
