SAGA Diagnostics achieves ISO 17025 accreditation by SWEDAC for mutation testing services

17 Jun 2021
Diane Li
Assistant Editor

Industry news

SAGA Diagnostics AB (“SAGA”), announced that it has successfully been accredited to the ISO 17025 standard for its leading-edge mutation detection laboratory services designed to radically improve cancer diagnosis, monitoring, and treatment outcomes. Granted by SWEDAC, the Swedish Board for Accreditation and Conformity Assessment, ISO 17025 is an international quality management standard used to assess the competency of analytical laboratories.

"The entire SAGA team is delighted with achieving this milestone as it demonstrates our commitment to providing the highest quality services and results to our rapidly growing number of customers in the biotechnology, pharmaceutical, academic, and hospital sectors." - Dr. Karolina Holm, Clinical Laboratory QA Manager of SAGA Diagnostics

SAGA is commercializing proprietary ultrasensitive technologies to quantify cancer-associated genetic aberrations in tissue and liquid biopsy samples which are uniquely capable of achieving limits of detection down to 0.001% mutant allele fraction. SAGA’s platform technologies, which are based on digital PCR and next-generation sequencing, are tools to be used in cancer patient stratification, therapy response monitoring, disease relapse identification, as well as in aiding in treatment decisions and as companion diagnostics.

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ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Cancer DiagnosticsThere are a wide variety of diagnostic tests for cancer available, and this range continues to expand as our knowledge of cancer improves. Current diagnostic methods include biopsy, imaging and blood tests for known biomarkers. New methods in research development include liquid biopsies and cancer breathalyzers.MutationMutations are changes in the DNA sequence that can lead to diseases, including cancer and genetic disorders. Analyzing mutations is crucial in diagnostics, drug development, and personalized medicine. Explore mutation detection tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Molecular DiagnosticsMolecular diagnostics use an individual’s genetic code and gene expression to diagnose and monitor diseases. The technique is used increasingly in the field of infectious diseases and oncology, as well as areas such as coagulation, HLA typing and pharmacogenomics. Molecular diagnostics plays a pivotal role in personalized medicine.PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.BiotechnologyBiotechnology is the use of biological processes, organisms, or systems in the production of products and services. It spans a wide range of applications, including healthcare, agriculture, and environmental management. Browse our peer-reviewed product directory to find the best biotechnology tools, compare products, check reviews, and get pricing directly from manufacturers.Cancer ResearchAlthough cancer is often referred to as a single condition, it actually consists of more than 100 different diseases. Microscopy, mass spectrometry, high throughput sequencing and flow cytometry are some of the most common techniques employed in cancer research labs.
SAGA Diagnostics achieves ISO 17025 accreditation by SWEDAC for mutation testing services