New Test Approvals Bring Momentum for Clinical Next Generation Sequencing
ROCKVILLE Md., May 3, 2018 /PRNewswire/ -- Kalorama says the NGS market has been influenced by the recent momentum shift from basic to translational research, which led to the development of several NGS-based clinical diagnostic tests for a variety of therapeutic areas, with a current emphasis on oncology. Some of these tests also received regulatory clearance in major markets, with three of them being approved by the US FDA in 2017, compared to only three other sequencing-based tests approved between 2013 and 2017. The healthcare market research firm completed its study of the market for Next Generation Sequencing (NGS) last month. The report says the global DNA sequencing market is a large market with an estimated $4.5 billion in product revenues in 2017, which are projected to continue to grow and reach approximately $8.9 billion in revenues in 2022.
The tests approved in 2017 are Illumina's Praxis Extended RAS panel for colorectal cancer, ThermoFisher Scientific's Oncomine Dx for non-small cell lung cancer, and Foundation Medicine's Foundation ONE CDx for melanoma, breast, colorectal, lung, and ovarian cancer.
However, clinical NGS testing is more difficult to regulate, as NGS-based tests generate large amounts of data that do not fit exactly into the previously-established categories of clinical diagnostics tests; while such tests typically detect a single disease or condition, one NGS test is equivalent to numerous tests belonging to the previous categories. To facilitate and accelerate the development of NGS-based tests, the US FDA released in July 2016 a draft guidance for the regulatory oversight of NGS-based in vitro diagnostics tests used for diagnosing germline diseases. The agency offers recommendations for designing, developing and validating NGS tests, and proposes the use of data from FDA-recognized public genome databases in order to support a test's clinical validity. The agency also created the precisionFDA cloud-based portal, which is intended to facilitate the sharing of data and tools among researchers in this field worldwide.
For clinical diagnostics applications, the most important features of an assay are simplicity, robustness, and accuracy; therefore, the current library preparation methods are still relatively complex for routine use in clinical settings, as clinicians have limited time and skills for such complex laboratory tasks. For such applications, technologies such as single molecule sequencing have an advantage, as they have easier sample preparation requirements; however, these technologies must improve in order to decrease their error rates to limits acceptable for clinical diagnostics.
Among areas in clinical or "Regulated Samples" expected to grow the fastest in terms of applications, labs that Kalorama surveyed said the following. Rare genetic or inherited diseases, followed by cancer and pharmacogenetics lead the list:
- Rare genetic/ inherited diseases - 75.9%
- Cancer - 24.1%
- Pharmacogenetics - 10.3%
The quality and amount of DNA samples is another important aspect for the development of clinical diagnostics, as a large proportion of samples are FFPE tissues, in which the DNA is typically degraded. The quality of DNA is a significant issue in particular for nanopore sequencing, therefore the development of this technology for clinical diagnostics has been challenging thus far. Moreover, given the miniaturization of samples in clinical diagnostics, the amount of sample inputs required by each technology is important in selecting the appropriate method for the development of clinical diagnostics.
As expected, the report said Illumina's platforms are the most favored in the development of such applications, partly due to their performance and availability, but also to their regulatory clearance by the FDA and other regulatory agencies worldwide. Additionally, the introduction of smaller sequencers is expected to further accelerate their development and commercialization for clinical sequencing applications.
Kalorama's report, Next Generation Sequencing Market by Product Type (Instrumentation, Consumables, Services), Application (Research, Clinical), by Method (Sanger, Next-Generation) and by Geographic Region, can be found at: https://www.kaloramainformation.com/Generation-Sequencing-Instrumentation-Consumables-Services-Competitive-Trends-11594541/.
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