Molecular Diagnostics

What is Molecular Diagnostics?

Molecular diagnostics refers to a collection of techniques that detect molecular characteristics (such as sequence, expression level, methylation status, etc.) of nucleic acids (DNA, RNA) or proteins in biological samples to reveal the mechanisms of disease occurrence and to assist in diagnosis, prognostic evaluation, and treatment guidance. Its core lies in analyzing disease biomarkers at the molecular level, overcoming the limitations of traditional pathology and biochemical testing, and offering high sensitivity (down to the single-molecule level), high specificity, and the potential for early diagnosis.

Its core value is embodied in three major areas: early diagnosis, precise subtyping, and treatment guidance. In infectious diseases, it enables confirmation within hours during the window period; in oncology, it supports companion diagnostics and dynamic monitoring; in genetic diseases and reproductive medicine, it facilitates carrier screening, non-invasive prenatal testing, and preimplantation genetic testing. Built on technical platforms such as PCR, digital PCR, next-generation sequencing (NGS), nucleic acid hybridization, and CRISPR, molecular diagnostics has become an indispensable cornerstone in infectious disease prevention and control, precision oncology, genetic disease management, and animal-origin testing.

Molecular Diagnostics Reference Materials (Standards) for Molecular Diagnostics

Molecular diagnostics reference materials (standards) are nucleic acid (e.g., armored pseudovirus) or protein reference substances with clearly assigned values, defined uncertainty, and established traceability chains. They serve as the “metrological ruler” for the entire molecular diagnostics system.

Molecular Diagnostics Reagents for Molecular Diagnostics

A regulatory-compliant molecular diagnostic test must deeply integrate molecular diagnostic reagents (which provide specific amplification/sequencing systems) with molecular diagnostic reference materials (which provide quantitative benchmarks). GeneMedi offers nucleic acid extraction reagents, nucleic acid molecular detection reagents, multiplex fluorescent quantitative PCR reagents, and other products covering multiple disease types. These are widely applied across various fields of life science research, including infectious disease detection, tumor detection, animal-origin testing (e.g., meat adulteration), and GMO detection, providing reliable tools for precise molecular diagnostics.