Analytical chemistry helps turn biological samples into measurements clinicians can use to make more individualised decisions. Sequencing can reveal genetic variants; mass spectrometry and chromatography can measure molecules; spectroscopy and imaging can add other kinds of information. These tools do not personalise care by themselves: a test must be accurate for its intended use, and its result must be clinically meaningful.
What analytical chemistry contributes to personalised diagnosis
Precision medicine uses differences among patients—including genetic, environmental and lifestyle factors—to tailor prevention and treatment. In some cancers, molecular testing already helps clinicians choose treatment based on a tumour’s molecular profile. FDA describes next-generation sequencing (NGS) as a way to examine large portions of a genome and identify genetic variants that can help diagnose, treat or understand disease.
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Analytical chemistry supplies the measurement: it identifies or quantifies a target in a sample. A separate interpretive step determines what that measurement means for a diagnosis or treatment decision. A biomarker may help detect disease, assess its progression or support a targeted therapy, but an association alone does not establish that using the biomarker improves care. NIST’s precision-medicine work addresses the measurement infrastructure behind such tests, including methods, reference materials and interlaboratory testing.
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| Tool | What it measures or contributes | Clinical context and important limit |
|---|---|---|
| Next-generation sequencing | Genetic variation across large portions of a genome | Used in some settings to help inform diagnosis and treatment, including molecularly guided cancer care. Test performance and variant interpretation matter; an instrument’s sequence output is only one part of the process. FDA also identifies bioinformatics tools, standards and variant databases as part of test development and evaluation. |
| Mass spectrometry | Molecular signatures and measured concentrations of compounds | A 2026 status review describes diagnostic use as limited but growing, with examples including therapeutic drug monitoring and precision dosing. This supports specialised laboratory applications, not a claim of universal routine access. |
| Chromatography and protein or metabolite analysis | Separation and analysis of proteins and small molecules | NCI lists chromatography and mass spectrometry among methods used in molecular analysis. They can contribute to biomarker discovery or measurement, but the measurement alone does not establish clinical usefulness. |
| Spectroscopy | Signals produced when materials interact with light or other forms of energy | NIST’s point-of-care pharmaceutical manufacturing framework includes Raman, UV-Vis and fluorescence approaches for material characterisation and quality control. This illustrates measurement in manufacturing and product assurance, not broad deployment as a diagnostic test. |
| Microfluidics and biofluidics | Small-volume sample handling combined with on-chip sensing | Research explores samples such as blood, saliva, urine, sweat and tears, with sensing that may use spectroscopy, electrochemical signals, colour changes or imaging. Compact sample-to-answer workflows are a technology direction, not evidence that a particular test is routinely available at the point of care. |
| Imaging and spatial analysis | Where molecular signals occur within a tissue or tumour | NCI identifies integration of imaging with molecular analysis, including mass spectrometry or proteomics, and high-resolution tumour mapping as areas for technology development and translation. |
How to judge whether a test can guide care
Analytical performance
First ask whether the method measures its intended target reliably in the intended sample. FDA treats analytical validation and clinical validity as distinct issues in the NGS test-development and oversight context: a technically dependable measurement is not, on its own, proof that a result predicts disease or treatment response.
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Clinical validity and usefulness
Clinical validity concerns whether the result is meaningfully associated with the condition or response it is intended to address. Clinical usefulness asks whether acting on the result can support a decision that matters to the patient. These questions are especially important for biomarkers: detecting a signal does not automatically make it a suitable basis for care.
Measurement comparability
Reference materials, shared methods and interlaboratory testing help establish whether measurements can be compared and trusted beyond a single instrument or laboratory. NIST’s precision-medicine programme includes work involving genomics, cancer biomarkers, the microbiome and flow cytometry, reflecting the breadth of the measurement challenge.
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Choosing a method starts with the clinical question
There is no universally best platform. A useful comparison begins with the information a clinician needs and the constraints of the test’s intended setting—not with the novelty of the instrument.
- Target: Identify the biomarker or analyte the test needs to detect or quantify.
- Sample: Check whether the method is suited to the specimen and the preparation it requires.
- Performance: Look for evidence of analytical validation for the intended use, then assess whether the result has clinical validity and usefulness.
- Workflow: Consider throughput, turnaround needs and whether the test is designed for a central laboratory or a point-of-care setting.
- Interpretation: For complex results such as genomic variants, account for bioinformatics and the standards or databases used to interpret them.
The sources describe different technology classes and applications, but do not establish a controlled head-to-head ranking. A method that answers one question well may not be suitable for a different target, sample or clinical decision.
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What is established—and what remains a direction for development
Molecular testing already informs treatment choices in some cancer settings, while mass spectrometry has specialised diagnostic applications such as therapeutic drug monitoring and precision dosing. Other developments should be described according to the evidence for their particular use: NCI’s technology categories include translational development areas, and a 2026 review presents biofluidics as a route toward compact diagnostic workflows rather than proof of routine clinical adoption.
Point-of-care also needs a precise meaning. NIST’s programme, updated in February 2026, concerns measurement science for point-of-care pharmaceutical manufacturing, including analytical control of ingredients and finished dosage forms. It is not evidence that personalised diagnostic testing in general has moved out of central laboratories. A compact device or small-volume assay becomes a clinical option only when the specific test and setting have appropriate validation and evidence.
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Regulatory descriptions require dates as well. FDA says it issued final guidance documents in April 2018 addressing clinical validity of genetic variant databases and analytical validation of NGS tests for suspected germline disease, and notes that standards and performance metrics must evolve with the field. That dated guidance history should not be mistaken for a complete statement of current regulatory requirements; those should be checked against FDA’s latest materials.
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Smaller samples, integrated sensors and richer molecular measurements may make more tailored testing possible. But the central challenge is connecting a dependable measurement to an interpretation that changes a real decision. Sequencing, mass spectrometry, spectroscopy, chromatography, imaging and microfluidics each contribute different signals; none is a substitute for validating the test’s performance and showing that its result is meaningful for its intended clinical use.
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