Getting LDT Validation Right the First Time with Streamline’s Validation Services

Validating a laboratory-developed test (LDT) is a task not relished by many labs—it’s a resource-intensive process prone to delays when minor oversights lead to repeated testing.
What’s more, resulting extensions not only drain budgets, but also morale.
All of this means that it pays to get it right the first time.

This is a pain point we’ve acutely felt at Streamline Scientific, leading us to create a best-in-class validation process that allows labs to easily navigate complex regulatory requirements, avoid common pitfalls, and get their LDTs up and running efficiently with less need for rework. 

Why Validation Is So Challenging for Labs

Even the most experienced laboratories aren’t immune to validation struggles, so what about the process makes it such a challenge? In short, it’s because validations aren’t something most labs do regularly, which means associated planning and execution fall outside routine lab staff competencies.

This means they end up encountering a variety of roadblocks:

• Unfamiliarity with the design and execution of validation protocols
• Adherence to specific CLIA, COLA, or CAP requirements can be nuanced
• Relevant reagents and equipment can be uncommon, needing dedicated sourcing
• Unusual clinical samples or microbial reference materials often have long procurement
  lead times

Each of these difficulties can lead to rework after the discovery of the issue and months of setbacks, or worse, outright failure. This wasted time can mean delayed results, lost revenue, and exposure to regulatory risk. In contrast, a well-planned and properly supported validation can be completed in just a couple of weeks.

How Streamline’s Validation Services Can Help

The right consulting partner can carry your lab seamlessly through the whole validation process—from planning to post-validation support. 

Streamline Scientific will help customize validation plans not only to your specific test and unique lab setup, but also to requirements set by CLIA, COLA, and CAP. We’ll help you source all the appropriate equipment, clinical samples, and reagents, as well as provide your lab staff with
on-site and remote training. After the validation is complete, we’ll help with reporting and ongoing support. 

Meet the Team Behind the Success

When it comes to LDT validation, expertise and close support matter. It is our expertly assembled team that drives Streamline’s industry-beating validation performance:

• Molecular Application Specialists
• PhD-level scientists
• Field Application Scientists

Backed by a CLIA-certified in-house reference lab, our validation team brings the years of experience needed to ensure your project's success.

Streamline’s Validation Services By the Numbers

Streamline Scientific has a track record of faster, smoother validations with labs across the country. Here’s what our capabilities look like in practice:

• 200+ labs supported throughout the validation process
• 1,500 total validations completed across a wide variety of assay types
• 99% success completion rate
• 13.5 days average per validation

These results are the product of a finely tuned, expert-led process.

Want to Learn More?

Our whitepaper takes a deep dive into how Streamline Scientific’s services can help your lab validate faster, avoid unnecessary rework, and ensure long-term success.