By Jason Meredith
Hospitals are becoming the new centers of innovation for novel clinical diagnostic tests. While this is enabling more sophisticated and personalized approaches to disease prevention, early diagnosis, and targeted treatment, it also has the potential to create major headaches for regulatory management of clinical labs.
Innovation of new clinical diagnostic tests in the regulatory environment will benefit from advances in automation.
Automation of laboratory-developed tests (LDTs) can significantly increase productivity. However, simplistic turnkey solutions are typically not flexible enough to cope with the ever-expanding range of technologies and tests being developed when automating assays for a GxP environment. To ease compliance worries and stay ahead of the curve in an increasingly competitive environment, clinical laboratories need flexible automation systems that are specifically designed for the regulatory environment.
Clinical laboratories are under growing pressure to manage increasing test volumes and more complex diagnostic assays, while at the same time facing budget cuts and a continuously evolving regulatory landscape. To thrive in this challenging environment, clinical laboratories are focusing their efforts in the niche areas that give them a competitive edge, which means that innovative LDTs and in vitro diagnostics (IVDs) are becoming more important than ever.
New legislation and guidelines in Europe and the US are leading to more stringent oversight of diagnostic tests. Compliance with new regulations, such as the latest European IVD directive, is increasing complexity and workloads in the clinical laboratory. At the same time, healthcare initiatives like the impending PAMA legislation in the US (due to take effect Jan. 1, 2018) signal unprecedented cuts in reimbursements to clinical laboratories. These forces threaten to drive clinical labs to the breaking point and have initiated a wave of laboratory consolidations through mergers and acquisitions.
As advanced and increasingly complex analytical methods and technologies transition from the research arena to the clinical diagnostics laboratory, greater flexibility and productivity are essential. Labs need to be able to bring new tests on board quickly, change assay formats on the fly, add modules and devices, and reconfigure workflows to support high throughput sample processing.
Molecular analytical and detection methods such as next-generation sequencing (NGS) and mass spectrometry (MS), feature among the technological advances driving innovation in today’s LDTs. The complex, multi-step sample preparation workflows required for these techniques often create bottlenecks. The growing need for better standardization across test panels creates an additional burden. Inevitably, clinical labs are implementing automated systems to overcome these challenges, and they face important choices when it comes to deciding which system will best fit their needs.
Closed, single-purpose platforms are common in clinical labs, and can seem like a logical option to reduce validation requirements and simplify test procedures. However, such “black-box” approaches to lab automation severely constrain flexibility and can hamper innovation. More open automation platforms are needed to deliver the level of flexibility required to adopt new analytical strategies and bring novel assays on stream quickly. Being able to adapt rapidly to changing needs reduces risk in the longer term.
When implementing a more flexible automation system into the laboratory, attention to regulatory compliance and quality are paramount. Laboratories risk noncompliance if factors such as controlled access, sample tracking, data traceability, record keeping and use of electronic signatures are not adequately addressed. Additionally, qualification processes such as validation may be complicated and time consuming if systems are not purpose-built for automating assays in the GxP environment.
The majority of open automation solutions are designed primarily for the research environment, and as such are not compliance-ready. Fortunately, leading instrument providers are now recognizing that compliant automation systems are a “must-have” for productivity and efficiency in today’s regulated clinical environment. The key to success lies in manufacturers having a solid understanding of current and future regulatory needs, and taking a proactive approach to compliance during the instrument design phase.
There is no denying that automation can enhance the speed and throughput of sample processing in a clinical lab. However, off-the-shelf liquid handling systems are not sufficient to overcome the challenging sample preparation and processing needs associated with today's LDTs and to give labs the flexibility they need to meet the demands for diagnostic testing at present and into the future. Automation solutions with compliance capabilities and features built in can truly improve lab productivity and better prepare clinical labs to survive and even thrive in an uncertain regulatory future.
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