November 2025 | Endo Lab & Medical Systems
Clinical Lab Newsletter
Innovation, Regulation, and Strategic Trends in Molecular
Testing & Remnant Sample Research
1) Labs’ Economic Impact: $140 B and 670K Jobs
A new report from the American Clinical Laboratory Association (ACLA) confirms U.S. clinical laboratories drive nearly $140 billion in annual economic activity and sustain about 670,000 jobs nationwide.
Why this matters:
Labs serve as economic anchors in both urban and rural markets, often among the largest healthcare employers outside of hospitals.
The findings strengthen advocacy for reimbursement stability under Medicare and Medicaid-positioning labs as essential infrastructure.
Every $1 spent on lab testing delivers roughly $6.60 in downstream healthcare savings through early detection and optimized care.
Action:
Leverage these data points in investor decks, partnership pitches, or local economic discussions.
If you are a new lab and are considering ways to grow revenue with your offerings contact ENDO. john.castelino@endogroupllc.com
2) Respiratory Illness Risk in the US (Nov 2025 - Feb 2026)
The next 3-4 months mark the peak of the 2025-2026 respiratory virus season in the US, driven by influenza (flu), COVID-19, and respiratory syncytial virus (RSV). As of mid-November 2025, national activity remains low, but early increases are underway with RSV among young children in the Southeast and South, and low but rising flu and COVID-19 cases.
CDC forecasts combined peak hospitalizations from all three viruses likely similar to or slightly higher than the severe 2024-2025 season (which saw up to 1.3 million flu hospitalizations and 130,000 deaths). An emerging H3N2 flu variant (subclade K) could intensify risks, potentially making this a harsher winter if it dominates as expected.
Action: Be prepared for efficient and accurate respiratory testing. Contact ENDO to discuss options for testing that ensures throughput and cost justification. Contact: john.castelino@endogroupllc.com
Also look to add to your revenue stream by selling your respiratory samples. To discuss options, contact: david.curley@endogroupllc.com
3) Tech & M&A Shake-Ups That Impact Labs
Thermo Fisher Scientific announced plans to acquire Clario (clinical trial data services) for up to $9.4 billion, expanding its reach into integrated clinical-data ecosystems.
The AHA and others renewed calls for CLFS reform before the 2026 rate reset.
Why this matters for Endo Lab:
M&A activity underscores a move toward data-rich, end-to-end diagnostic ecosystems combining test results, analytics, and clinical metadata.
Supply-chain consolidation could alter reagent pricing and platform availability.
Action: Review vendor dependencies and evaluate collaborations with smaller, AI-driven analytics firms to complement existing partnerships.
4) Biospecimen Remnant Collection – Compliance & Strategy Update
Remnant specimens remain a cornerstone of translational research, but regulatory scrutiny is increasing.
Key compliance reminders:
Only properly de-identified or coded specimens qualify as non-human-subjects research under the Common Rule; HIPAA de-identification must follow Safe Harbor or Expert Determination methods.
Chain-of-custody, transport, and annotation quality directly determine specimen usability.
Emerging trend: The NIH and major pharmas now prioritize diversity & representativeness in biospecimen cohorts. Labs capable of stratifying de-identified samples by demographic or clinical phenotype gain new contracting advantages.
Action: Expand your data schema to include age, sex, ethnicity, and diagnosis fields while maintaining HIPAA compliance. Strengthen your BAAs, MTAs, and audit documentation before Q1 2026.
If you currently do not have a remnant sample program and would like to establish this new revenue stream, contact ENDO. david.curley@endogroupllc.com
5) Workforce & Automation: A Balancing Act
Industry data show continued shortages in MLS/MLT roles, even as automation and AI reshape pre-analytic and post-analytic workflows.
Why this matters:
Recruiting remains competitive, driving up wage pressure.
Automation can offset staffing challenges, but integration costs and validation timelines must be managed carefully.
Action: Assess which workflows (aliquoting, accessioning, QC tracking) can be automated in 2026, and explore workforce-development grants for lab training partnerships.
Industry Events
Fun Fact:
Roughly 70% of all medical decisions are influenced by data produced in clinical laboratories-yet lab testing accounts for less than 1% of total U.S. healthcare spending.
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.
