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5.2 Aptamer-Based Medical Devices for Diagnosis
5.2.1 Biomarker Detection
Biomarkers are highly correlated with the changes or possible changes in the structure and/or function of systems, organs, tissues, cells and subcells. They govern
biological processes and indicate the biological state of the target subject. On one
hand, biological processes or disease progression are usually controlled by some
specific biomarkers, which further affect numerous cell types. On the other hand,
some specific biomarkers are also generated during the corresponding biological
processes. Biomarkers can be utilized to diagnose diseases, determine disease stage
and prognosis, monitor the metabolic status of the body, or evaluate the safety and
efficacy of new drugs or therapies in targeted populations. Generally, biomarkers
can be hormones, peptides, lipids, proteins, pathogen nucleic acids, and cells. Their
detection medium can be many kinds of body fluids (e.g. saliva, blood, etc.), feces,
tissue samples, hair, etc.
As its definition depicts, aptamers can specifically recognize and bind to their
targets, whose range are from small metal ions to large tumor cells or microorganisms.
In the field of medical devices, they are most widely used in biomarker detection.
Nowadays, rapid, accurate and noninvasive detection of biomarkers is one of the
methods to determine the type and stage of diseases, and it has become a thriving
field for the development of medical devices for detection.
Founded in 2000 by Larry Gold, SomaLogic has scanned the living data stream of
human proteins through aptamer-based technologies with greater precision, sensitivity and scale than anybody in the world. These data have been translated into
actionable insights for every seeker and enabler of human health. This company is
launching the digital precision health management new ideas, through proteomics
method determination of tens of thousands of human body protein data rather than the
genetic data. It is working with leading academic institutions and biobanks around the
world to assemble the world’s largest database of protein measurements, applying
their SomaScan® Assay to thousands of samples with extensive clinical outcome
data [10]. It is also using complicated device learning and bioinformatics capabilities to transform the massive collection of data into quantitative risk assessments and
reliable physiological and lifestyle insights [11–13]. The company’s mission is to
use its proprietary modified aptamer-based proteomic technologies to develop a wide
range of enhanced protein analysis tools and reagents for the life sciences community, to facilitate biomarker discovery and validation for diagnostic and therapeutic
applications, and to develop and commercialize clinical diagnostic products that will
improve the delivery of health care by offering timely and accurate diagnostic information to physicians and their patients [14]. As of January 2020, this company owns
or controls over 460 domestic and foreign issued patents, and over 237 domestic
and foreign pending patent applications [15]. Many of them are potentially to be
approved by the authorities as medical devices.
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