Somewhere in the world, a clinician analyses a new-born baby’s blood; what she finds can potentially save his life, as the test she uses has been carefully developed to detect the molecular traces of a specific disorder. This laboratory developed test (LDT), and many others like it, is fast becoming an essential part of the diagnostic toolkit used by healthcare providers across the developed world.
But as the use of LDTs has grown, so too have calls for their standardisation. These calls are being met with new regulations designed to improve reproducibility and enhance patient safety. But what impact will these regulations have on the healthcare industry, and how will they affect clinicians, manufacturers and ultimately, patient health?
Why should LDTs be regulated?
Superficially, the broader application of LDTs is brilliant news for patients. The more easily and accurately we can diagnose diseases, the better we can treat them using more effective and personalised therapies.
But looking deeper, there is an important problem with the current use of LDTs; a lack of interlaboratory standardisation means that a test developed in one lab may be very different to a test developed to measure the same disorder in another lab. This disparity raises concerns about reliability, given that two different LDTs designed for the same disease can produce entirely different results. This could potentially affect the accuracy of disease diagnoses and have serious consequences for patient care.
Therefore, proper standardisation of LDTs may be a crucial step for the healthcare industry. In light of this, the US Food and Drug Administration (FDA) two years ago released its draft guidance on the regulation of LDTs calling for better standardization and, in response to mixed feedback from within the industry, issued a discussion paper on the topic earlier this year. Although it’s still early days, this marks a big step towards operative LDT regulation to ensure the highest standards of diagnostic testing are adhered to.
What do LDT regulations mean for clinicians, manufacturers, and patients?
These regulations are undoubtedly useful resources for clinicians to harmonise LDTs and harness their exciting potential in disease diagnosis. This may help improve diagnoses and help drive a precision medicine approach that can target the specific biological pathways responsible for patients’ individual diseases.
The adoption of standardised approaches, however, is likely to be a costly process for some. For example, if labs are in the process of validating or using specific assays, they are likely going to need to adjust their methods so that they meet the new standards. This has obvious time- and resource-constraints associated with it, but is necessary for the development of universal LDTs that are in keeping with sanctioned guidelines.
It is also likely that clinicians will increasingly demand products and standards from manufacturers that meet these regulations. For example, many LDTs are based on liquid chromatography-mass spectrometry (LC-MS) techniques, so there is likely to be an increasing demand for LC-MS products that facilitate assay harmonisation across laboratories.
In the short term, manufacturers of LC-MS technologies won’t be affected by the proposed regulations, because they are legally restricted in making ‘off-label’ claims about the intended use of their products. However, it could have a much bigger impact on manufacturers of 'certified reference materials' (i.e. the controls used to validate particular analytical instruments/methods), because these measurement standards will play a key role in harmonising LC-MS assays.
Whatever the technology used to develop LDTs, it is likely that rising pressure will mean that manufacturers will need to start developing solutions that satisfy the standards developed by the FDA. There are positives to this however, as the standardisation of methods could potentially help laboratories with acquiring FDA approval for their LDTs, something that some within the industry currently perceive to be a difficult process. This in turn may help ensure products are made more rapidly available to the global market.
What’s next for LDT regulation?
As technological and research advances widen the potential of diagnostic tests, further guidelines providing clear direction on LDTs will be needed to standardise their use and ensure patient safety. Ultimately, once these are in place, properly understood and implemented by our clinician by using the highest quality tests available to her, she will be better able to protect the life of the new-born baby, and many others like him.
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