Clinical Research & Labs News
July 2025 Edition - Happy 4th of July
1. PCR Equipment Market Expands: Here’s What to Watch
The global PCR machine market is projected to grow from $6.57 billion in 2025 to $9.57 billion by 2034. Key drivers? Faster workflows, mobile setups, and AI integration.
PCR Trends to Know:
Ultra-fast thermal cyclers for STAT testing
Wi-Fi-enabled instruments with cloud-based result access
Growth in applications: infectious disease, oncology, food safety, and even wastewater surveillance
Lifecycle planning: Labs upgrading aging PCR fleets now to keep pace
ENDO Insight: If your PCR instruments are more than 5 years old, this is the time to evaluate new platforms. Ask us about our preferred vendors and demo programs. Are you maximizing the capabilities of your PCR equipment? Interested in finding our about additional services you can offer with your existing equipment contact John Castelino @ john.castelino@endogroupllc.com
ENDO Takeaway: As technology evolves, strategic partnerships with AI platforms and certified labs are no longer optional—they’re critical.
2. July Industry Events You Shouldn’t Miss
Conference season is in full swing, and this month offers some of the best opportunities to learn, network, and explore the future of diagnostics.
Top Picks for July 2025:
ADLM 2025 Clinical Lab Expo (formerly AACC)
Chicago | July 27–31
FEMS MICRO 2025 – Milan, Italy | July 14–17
ASV 2025 – American Society for Virology – Montreal, Canada | July 14–17
Pro Tip: Follow social media hashtags (#ADLM2025, #FEMSMICRO25) and register early for virtual sessions if you can’t attend in person. ENDO will be at ADLM. If interested in meeting with us, contact David Curley @ david.curley@endogroupllc.com
3. Remnant Sample Access Faces Tightening Restrictions
With increased attention on data privacy and consent, clinical labs are facing new hurdles when accessing leftover biospecimens for research and validation.
What’s Changing?
Hospitals are pausing remnant release programs due to vague or missing consent language
IRBs and compliance teams are requiring explicit remnant-use policies
Labs are re-evaluating requisition form language for compliance with HIPAA, CLIA, and OHRP standards
Some institutions now demand either patient opt-in or opt-out options to use samples post-testing
What You Can Do:
Review all requisition forms for clear consent language
Establish written SOPs for remnant use
Engage compliance/legal early—don’t wait for an IRB block to slow down your project
Working with a company that knows the ins and out of remnant samples is key to staying up on changing trends. If interested in collecting and selling your remnants, contact David Curley @ david.curley@endogroupllc.com for a free samples consultation.
4. CLIA 2024: What the New Interpretive Guidelines Mean for You
In January 2024, CMS released updated CLIA interpretive guidelines that have wide-reaching implications for molecular and clinical labs. These changes are already altering workflows, staffing, and reimbursement.
Key Updates & Impacts:
Target-by-target validation now required for all multi-analyte molecular tests
Must provide accuracy and precision data for each analyte, not just the overall panel
Payer scrutiny has increased—many labs report temporary reimbursement delays
Hiring surge for QA/QC and regulatory affairs professionals to keep up with documentation
Labs with proactive verification protocols are already winning more contracts due to payer confidence
ENDO Tip: Don’t wait—review your LDT verification strategy now. Need help? We can connect you with partners experienced in CLIA compliance overhauls. Contact Jason Heffner @ jason.heffner@endogroupllc.com
5. Clinical Genomics Market Surges with AI and Accreditation Momentum
The global clinical genomics market hit $1.06 billion in 2024 and is projected to climb to $1.25 billion by 2025, fueled by increased demand for personalized medicine and AI-driven diagnostics.
What’s Driving the Growth?
Expansion of NABL-accredited and CAP-certified molecular labs globally
Increased use of AI for variant analysis, reporting, and decision support
Government grants and VC investment in oncology and rare disease diagnostics
Bottlenecks in bioinformatics talent and infrastructure, especially in emerging markets
ENDO Takeaway: As technology evolves, strategic partnerships with AI platforms and certified labs are no longer optional—they’re critical.
Quick Lab Tip:
If you're waiting on legal or compliance reviews, keep momentum by collecting logistics data like 6-month sample history or consent form screenshots in parallel.
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.
