Companion diagnostics (CDx) are molecular assays that measure levels of proteins, genes, or specific mutations to reveal a specific, efficacious therapy for an individual’s condition. CDx are a form of personalized, stratified, and precision medicine due to which a patient’s treatment will become increasingly individualized. CDx has expanded from a handful of oncology drugs with corresponding diagnostics to include multiple therapeutic areas, and the number of combinations has grown significantly over the years. However, oncology remains the largest segment for FDA-defined marketed drugs with CDx.
The CDx thematic research report looks at the CDx medical devices market and some of the oncology biomarkers, indications, and diagnostic technologies being utilized. The market for biomarker testing continues to increase due to increases in disease, awareness, improved accessibility to personalized medicine, and technological advancements.
What are the key techniques in CDx?
The key techniques used in CDx are immunohistochemistry (IHC), in situ hybridization (ISH), nucleic acid amplification (NAAT), and gene sequencing methods such as Sanger sequencing and next-generation sequencing (NGS).
IHC is a widely used, antibody-based technique that detects the presence of specific antigens or proteins in tissue. Frequently, chromogenic detection methods are used to visualize antibody-antigen interactions, allowing for the evaluation of cellular localization and staining patterns in the context of tumor structures.
In Situ Hybridization
ISH involves the denaturation of DNA or RNA to form single-stranded molecules, which naturally re-anneal to labelled probes made up of complementary nucleic acid sequences. Fluorescence in situ hybridization (FISH) uses probes that are directly labelled with fluorophores, antigens, or biotin. These are then subsequently bound by fluorescently tagged secondary compounds such as antibodies or streptavidin.
Nucleic Acid Amplification
A NAAT involves the amplification of specific nucleic acid sequences related to a target gene or mutation. NAATs invariably involve polymerase chain reaction (PCR) consisting of three main steps, which are repeated many times in cycles to amplify a target DNA sequence.
Sanger sequencing is a DNA sequencing technique that uses modified, chain-terminating dideoxynucleotides (ddNTPs).
NGS technology is increasingly being applied in clinical practice. The technique is highly scalable and typically involves fragmenting the genome and then randomly sampling for and sequencing these fragments. NGS can be performed on formalin-fixed and paraffin-embedded (FFPE) and freshly collected tissue specimens, as well as on fine-needle aspiration samples and small biopsy specimens.
What are the key trends in CDx?
The key trends in CDx are technology trends, macroeconomic trends, and regulatory trends. Technology trends include big data, artificial intelligence (AI), biomarker testing, laboratory developed tests, next-generation sequencing, and liquid biopsies. The decreasing cost of genetic testing as well as a collaboration between diagnostic and pharmaceutical companies come under macroeconomic trends. The impact of clinical guidelines is a part of regulatory trends.
Which are the key public companies associated with CDx?
Some of the key public companies associated with CDx are Abbott Laboratories, Agilent Technologies, bioMerieux, Illumina, and Thermo Fisher Scientific.
Which are the key private companies associated with CDx?
Some of the key private companies associated with CDx are Asuragen, Foundation Medicine, MilliporeSigma, and Roche Diagnostics International.
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Market report scope
|Key techniques||Immunohistochemistry (IHC), In Situ Hybridization (ISH), Nucleic Acid Amplification (NAAT), and Gene Sequencing Methods|
|Key public companies||Abbott Laboratories, Agilent Technologies, bioMerieux, Illumina, and Thermo Fisher Scientific|
|Key private companies||Asuragen, Foundation Medicine, MilliporeSigma, and Roche Diagnostics International|
- Identifies those companies most likely to succeed in a world filled with disruptive threats.
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Thermo Fisher Scientific
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