The Frontier of Fluid Biomarkers: Top 5 Global Central Labs for Alzheimer’s and NDD Clinical Trials
Finding the right specialised laboratory partner can make or break clinical trials, especially in the neurodegenerative disease (NDD) landscape. Startups, companies, and labs researching Alzheimer’s and Parkinson’s need laboratories that can handle blood-based biomarkers like plasma p-tau217, as well as options that offer rapid logistics and cutting-edge automated platforms.
But where can such firms be found? Fortunately, this review has some answers for you. We look at some of the top global central labs for Alzheimer’s and NDD clinical trials worldwide so you can make a choice about which one might be best for you.
Best for mid-size and emerging biotechs requiring specialised NDD biomarker validation – MLM Medical Labs
If you are a mid-size or emerging biotech requiring specialised NDD biomarker validation, we recommend MLM Medical Labs. MLM holds Health Institution status under EU IVDR, providing sponsors with a regulatory-compliant path to deploy exploratory assays at LDT/IVDR status for European studies.
What’s nice about MLM Medical Labs is the sheer range of options that it provides. For example, it focuses on Alzheimer’s disease, providing validated blood-based and CSF testing for Aꞵ-40, Aꞵ-42, and the Aꞵ-40/42 ratio, alongside other tau pathology testing including:
- p-tau181
- p-tau217
- p-tau231
- the p-tau217/A-beta 42 ratio
There’s also broad CNS expertise to support MSA, LBD, and Parkinson’s trials, as well as a high level of regulatory and platform agility, with assays supported by current industry implementation, including Lumipulse and ELISA platforms.
Ultimately, we were impressed by MLM because of its global e-requisition capabilities and the fact that sponsors maintain digital visibility over their trials through the laboratory’s online portal. It also has global reach, with laboratories across Africa, the EU, and the US.
Best for massive multi-country phase three trials – Q2 Solutions
If you are conducting a massive, multi-country Phase 3 trial for your biotech or medical startup, you might want to consider Q2 Solutions, a joint venture between IQVIA and Quest Diagnostics. The laboratory offers a massive global infrastructure and is able to support enormous patient intakes. Its edge comes from its scale and connected intelligence. Q2 Solutions can scale assays across standard platforms and seamlessly integrate laboratory logistics with IQVIA’s clinical trial management and patient recruitment analysis.
But it’s not all good news, though. Companies looking for highly specialised protocols or emerging biotechs may find Q2 Solutions’ approach quite rigid. They can also sometimes feel deprioritized compared to larger clients with bigger budgets.
Best for large-scale international trials needing multi-site global sample preservation – Eurofins BioPharma Services
Eurofins BioPharma Services is located in Luxembourg and focuses on providing services for the biggest international trials that need rapid global sample preservation. Because of this, it has an enormous footprint across the globe in more than 70 countries.
For NDD trials in particular that need regional processing at regional hubs to avoid degradation on long shipping routes, Eurofins is a top choice. Incredibly, the laboratory claims a sub-10-hour global turnaround time from the point of collection to the freezer, giving them a distinct logistical advantage over their rivals.
The labs’ highly diversified global network means that many trials have to integrate with multiple third parties and regional entities. This means that the administrative costs of working with this particular company can be higher unless managed properly or unless you have an experienced administrator in-house.
Best for early phase 1 or phase 2 trials needing sensitive biomarker quantification – Frontage Laboratories
Let’s say you have an early Phase 1 or Phase 2 trial needing sensitive biomarker quantification. In this case, it is difficult to know which particular laboratory to turn to. Fortunately, Frontage Laboratories has carved out a niche for itself to serve this particular type of client. While other laboratories might focus on clinic-ready automated systems, Frontage Laboratories believes more in custom bioanalytical assay development, quantification, and validation.
For example, Frontage uses the Quanterix Simoa Analyzer. Interestingly, this allows the laboratory to detect very low levels of NDD biomarkers that might be found in asymptomatic patients or in pre-clinical patient samples. The idea here is to offer clients a more sensitive approach that enables them to enrich their data with more interesting findings. This is particularly important for neurological biomarkers like p-Tau217 that might be in tiny concentrations in the blood and yet still indicate a disease state.
The downside of using this particular option is the special nature of the services that it offers. Unlike conventional, traditional full-service central labs that handle all heavy global kit building, Frontage may need to be combined with other services to deliver everything that clients require.
Best for mid to large scale trials needing European regional expertise – Cerba Research
Lastly, if you are looking for a partner for a mid- to large-scale trial in the European area, consider Cerba Research. This is a European laboratory network that has aggressively expanded its biomarker and translational footprints in recent years, including into emerging markets in Asia Pacific. It is famous because of its specialised pathology, immunology, and metabolic assay menus. These are highly competitive in the European space and provide clients with even more options for connecting with validated clinical endpoints.
Many startups and companies focusing on NDD use this laboratory because of its ability to assist with regulatory compliance. It understands the scrutiny that many firms, laboratories, and trials face, and it can help clients work around these issues with care. While it is highly capable across Europe and expanding globally, its US lab footprint is low, and it relies heavily on partners. This means that service quality can vary depending on which facility you use.
Final verdict: Who offers the best global labs for Alzheimer’s and NDD clinical trials?
The competition for the best global labs for Alzheimer’s and NDD clinical trials is strong, but our top pick has to go to MLM Medical Labs. This is because of the tremendous specialisation it has in NDD biomarker validation. It’s able to offer numerous blood-based and CSF testing methodologies, including various p-tau markers. For this reason, we’re giving it our five out of five star rating.