How does automated liquid handling drive efficiency in Laboratory Developed Tests?

09/10/2023

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What are LDTs and why are they important?

Laboratory Developed Tests (LDTs) are specialized diagnostic tests designed, manufactured, and used within a single laboratory. These tests fulfil critical needs in healthcare, enabling rapid and specialized diagnostics for a wide array of targets such as RNA, DNA, and proteins. Often essential for diagnosing rare diseases and facilitating personalized medicine, LDTs come into play especially when commercial tests are impractical or unavailable. Due to their crucial role in guiding treatment decisions, it's vital that LDTs undergo rigorous validation to ensure their accuracy, making them indispensable tools in modern healthcare.

 

The role of LDTs in personalized cancer treatment

LDTs employing Next-Generation Sequencing (NGS) have gained immense significance as companion diagnostics for personalized cancer care. These NGS-driven LDTs identify specific genetic markers in patients, enabling healthcare providers to tailor treatments more effectively. NGS technology allows multiple genes to be assessed in a single assay, eliminating the need for multiple tests and offering a faster, more economical diagnostic solution while extending the utility of valuable clinical samples.

 

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Automated liquid handling boosts the precision and efficiency of LDTs

Automated liquid handling solutions are revolutionizing how labs perform NGS-driven LDTs by significantly enhancing both accuracy and efficiency. These automated systems are a cost-effective way to help labs meet ambitious Key Performance Indicators (KPIs). By automating laborious and repetitive pipetting tasks, human error is minimized and skilled personnel are freed up for other crucial activities. This contributes to more efficient and streamlined workflows, reducing turnaround times and getting results to patients faster. Furthermore, automation allows labs to effortlessly scale their operations to meet future testing demands, positioning them for adaptability in the ever-evolving fields of personalized medicine and cancer care.

 

  

Key considerations when choosing an automated liquid handling solution for LDTs

As laboratories operating at high throughput levels face pressure to maintain quality and meet regulatory requirements, choosing an automated liquid handling solution for LDTs requires thoughtful consideration.

 

Consider the level of technical support and maintenance services offered by the vendor. This can be crucial for minimizing downtime and ensuring the longevity and reliability of the system.

A complex, difficult-to-use system can slow down operations and increase the likelihood of errors. A user-friendly interface and straightforward operation are key for efficiency.

A new system must meet all regulatory requirements for LDTs, which may include specific quality control and data reporting features.

As LDTs evolve, a flexible system that can adapt to new methodologies and assays is invaluable. This can be especially important for labs that plan to expand into new areas of testing.

 

Conclusion

Automated liquid handling systems are proving to be a transformative technology in the landscape of Laboratory Developed Tests (LDTs), especially those utilizing Next-Generation Sequencing (NGS) for personalized cancer care. By enhancing accuracy, boosting efficiency, and offering scalable solutions, these systems enable labs to meet current and future challenges more effectively. However, given the high stakes and regulatory rigor associated with LDTs, it's essential for labs to make well-informed choices when implementing automated solutions. The right system not only improves the quality of diagnostics but also positions labs to be agile and adaptive in a rapidly advancing healthcare environment.

 

References

  1. FDA 2023, Laboratory Developed Tests, FDA https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests
  2. Pallavi Upadhyay PhD 2022, Current Challenges Facing Lab Developed Tests, Today’s Clinical Lab https://www.clinicallab.com/trends/clinical-lab-business-management/current-challenges-facing-lab-developed-tests-26502