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.
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:
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.
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.
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:
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 Scientific has a track record of faster, smoother validations with labs across the country. Here’s what our capabilities look like in practice:
These results are the product of a finely tuned, expert-led process.
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.