Clinical Research & Labs News
May 2025 Edition
1. Multi-Omics and Phenotypic Data Drive Clinical Research Forward
The integration of multi-omics (genomics, proteomics, metabolomics) with detailed phenotypic data is revolutionizing clinical research and precision medicine. Key advantages include:
Deeper Disease Insights: Combining molecular and clinical profiles reveals previously undetected disease subtypes.
Target Discovery: Multi-omics approaches accelerate identification of druggable targets.
Enhanced Trial Design: Patient stratification based on omics signatures improves enrollment precision and outcome analysis.
If you are a lab running a high-volume of blood tests and are interested in learning how to capitalize by providing your remnant blood samples, contact: David.curley@endogroupllc.com
2. CMS Proposes Overhaul of Clinical Lab Fee Schedule (CLFS)
The Centers for Medicare & Medicaid Services (CMS) has proposed significant updates to the Clinical Lab Fee Schedule to reflect advances in diagnostic technology and cost efficiencies. Key provisions include:
Market-Based Pricing Adjustments: Pricing will better reflect current commercial payment rates.
Tiered Reimbursement for Molecular Tests: Higher complexity tests may receive increased payment.
Administrative Simplification: Streamlined reporting and audit procedures aim to reduce administrative burden.
Consider moving away from broad panel offerings to custom panels with specific targets that align with the tiered reimbursement. If you would like to know more about how you do this, contact John Castelino @ ENDO Lab and Medical: john.castelino@endogroupllc.com
3. Trends in Clinical Lab Consolidation Continue
The trend of mergers and acquisitions in the lab industry shows no signs of slowing. In Q1 2025 alone, three major acquisitions were announced, driven by:
Operational Scalability: Larger networks reduce redundancy and increase cost efficiency.
Technology Integration: Consolidated labs are more likely to implement centralized LIS and automation.
Access to Capital: Investment groups remain attracted to the stability and scalability of diagnostic testing services. Independent labs should proactively assess their competitive positioning and potential for strategic partnerships.
Q1 Major Acquisition Announcements are as follows:
Labcorp's Acquisition of BioReference Health's Oncology and Clinical Testing Services (Specialized Diagnostics Expansion)
Sonic Healthcare's Acquisition of LADR (Laboratory Group Dr. Kramer and Colleagues) ($698M in cash and shares)
Brookfield's Acquisition of Antylia Scientific ($1.4B)
4. Monkeypox Testing Updates: CDC Recommends Expanded Surveillance
The CDC has issued new guidance recommending that clinical labs broaden monkeypox testing beyond symptomatic patients, in light of recent localized outbreaks. Key points:
Expanded Testing Criteria: Includes asymptomatic individuals in high-risk communities.
Sample Types: PCR-based testing from lesion swabs and new protocols for blood-based detection.
Data Sharing Emphasis: CDC is urging real-time reporting to state and federal health systems.
Labs are encouraged to update their protocols and prepare for potential surges in test volume.
If you are not currently running a Monkeypox Panel and are interested in learning about options to add this to your molecular offering, contact John Castelino @ ENDO Lab and Medical: john.castelino@endogroupllc.com
Interesting Fact of the Month
Did you know? The average Phase III clinical trial collects over 3 million data points, including more than 150 biological samples per participant across the trial’s duration. That’s a lot of tubes!
