SeraCare Life Sciences has been assisting in the development of advanced diagnostics for over three decades, and has grown and added capabilities over the years including becoming a trusted supplier of critical raw materials such as processed plasma and in-kit control technologies for most of the leading in-vitro diagnostic (IVD) infectious disease platforms globally. Vice-president for precision medicine Trevor Brown discusses the key challenges facing the IVD technology industry, and the trend he sees developing in the coming years.
Trevor Brown: I lead the molecular and precision medicine business unit for SeraCare Life Sciences. Our business unit serves the in-vitro diagnostic development markets by providing critical tools and technologies that help to accelerate and improve diagnostic assay development programmes. We partner with IVD developers around the world, specialising in natural and engineered products - primarily for infectious disease and autoimmune diagnostics.
If you wanted to boil it down to the one thing we are most proficient at, it would be that we are the best in the world at making a biosynthetic product look like a real patient specimen.
I would say one of the the biggest challenges is the speed at which technologies are advancing and how rapidly they've been adopted into the clinic. The majority of all of the new precision medicine tests using NGS and dPCR for profiling tumours, non-invasive oncology and reproductive health tests are being developed as laboratory tests in clinical laboratories themselves, rather than with the traditional IVD developer model.
This mainly has to do with the complexity of the platforms and the regulatory environment that has struggled to keep pace. While the opportunities and applications seem to expand overnight, the bar is high for an IVD developer to bring one of these new tests through a regulatory submission. And if they are successful, the question raised is how they will ensure the result, and be able to quickly and efficiently troubleshoot problems.
The other side of it is that with labs under CLIA/CAP, there are hundreds of self-developed and self-validated assays being brought to market. It has been noted that not all of these may be at the same level of development rigour and validation - many of the common tools are available to infectious-disease test developers, but almost none of the types of quality-control tools being widely used across labs that are serving to track the daily, weekly and monthly performance of the assays. Many of these are built using non-GMP, RUO reagents from companies new to the IVD world.
The combination of technological innovation and increasingly effective pharmaceuticals for global diseases such as HIV, hepatitis C and cancer is already changing the landscape of healthcare. Whether it means increased standardisation of high-complexity testing or the decentralisation of more routine infectious-disease testing into the community, the focus needs to be on how trustworthy the result is.
We already see traditional diagnostic powerhouses such as Roche moving solidly into the NGS space, which will no doubt bring a level of much-needed diagnostic experience into the primarily RUO-based world. We are also seeing a recognition of the importance of data quality and the ability to not only use that data to trend internal performance, but also to look externally and see how others are performing when using the same 'ground truth' tools for their assays.
Only when the industry begins to adopt quality performance measures as a normal part of running these new diagnostic tests - be it a rapid point-of-care device testing chlamydia trachomatis at a physician-office laboratory or a laboratory-developed test profiling a biopsied tumour in a hospital molecular pathology lab - will the certainty of results meet the potential for positive patient impact.
SeraCare Life Sciences